Trial Outcomes & Findings for Impact of Periodontal Therapy on Patients With Diabetes (NCT NCT04830969)
NCT ID: NCT04830969
Last Updated: 2023-03-01
Results Overview
Periodontal PD in millimeters is measured with a UNC-15 periodontal probe on 6 sites per tooth; site status is compared between timepoints measured
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
116 participants
Primary outcome timeframe
Baseline to 6 months
Results posted on
2023-03-01
Participant Flow
Of 116 enrolled participants, 114 met inclusion criteria and were randomized for treatment
Participant milestones
| Measure |
A: SRP + SPT
The first group, A, includes diabetics and non-diabetics with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
|
B: SRP
The second group, B, includes diabetics and non-diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
|
|---|---|---|
|
Overall Study
STARTED
|
58
|
56
|
|
Overall Study
COMPLETED
|
45
|
41
|
|
Overall Study
NOT COMPLETED
|
13
|
15
|
Reasons for withdrawal
| Measure |
A: SRP + SPT
The first group, A, includes diabetics and non-diabetics with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
|
B: SRP
The second group, B, includes diabetics and non-diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
2
|
|
Overall Study
Protocol Violation
|
3
|
9
|
|
Overall Study
Lost to Follow-up
|
4
|
4
|
Baseline Characteristics
Impact of Periodontal Therapy on Patients With Diabetes
Baseline characteristics by cohort
| Measure |
Diabetic + SRP + SPT
n=21 Participants
The group includes diabetics with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
|
Diabetic + SRP
n=23 Participants
The group includes diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
|
Non-Diabetic + SRP + SPT
n=24 Participants
The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
|
Non-Diabetic + SRP
n=18 Participants
The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
60.9 years
STANDARD_DEVIATION 8.8 • n=99 Participants
|
66 years
STANDARD_DEVIATION 8.7 • n=107 Participants
|
65.5 years
STANDARD_DEVIATION 10.9 • n=206 Participants
|
62.3 years
STANDARD_DEVIATION 7.3 • n=7 Participants
|
63.8 years
STANDARD_DEVIATION 9.2 • n=31 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
32 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
54 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
86 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
African American
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
15 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
76 Participants
n=31 Participants
|
|
Education
|
15.6 year
STANDARD_DEVIATION 2.4 • n=99 Participants
|
16.1 year
STANDARD_DEVIATION 2.1 • n=107 Participants
|
15.1 year
STANDARD_DEVIATION 2.3 • n=206 Participants
|
13.8 year
STANDARD_DEVIATION 1.8 • n=7 Participants
|
15.2 year
STANDARD_DEVIATION 2.3 • n=31 Participants
|
|
BMI
|
32.5 kg/m^2
STANDARD_DEVIATION 5.1 • n=99 Participants
|
32.5 kg/m^2
STANDARD_DEVIATION 6.8 • n=107 Participants
|
29.6 kg/m^2
STANDARD_DEVIATION 5.6 • n=206 Participants
|
27.7 kg/m^2
STANDARD_DEVIATION 4.9 • n=7 Participants
|
30.7 kg/m^2
STANDARD_DEVIATION 5.9 • n=31 Participants
|
|
Smoking History
Never Smoked
|
9 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
47 Participants
n=31 Participants
|
|
Smoking History
Former
|
11 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
37 Participants
n=31 Participants
|
|
Smoking History
Unknown
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Alcohol Intake
Never
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Alcohol Intake
Former
|
7 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
22 Participants
n=31 Participants
|
|
Alcohol Intake
Current
|
13 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
55 Participants
n=31 Participants
|
|
Alcohol Intake
Unknown
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
Whole Mouth Mean Pocket Depth
|
3 mm
STANDARD_DEVIATION 0.5 • n=99 Participants
|
2.7 mm
STANDARD_DEVIATION 0.2 • n=107 Participants
|
2.9 mm
STANDARD_DEVIATION 0.4 • n=206 Participants
|
2.8 mm
STANDARD_DEVIATION 0.3 • n=7 Participants
|
2.8 mm
STANDARD_DEVIATION 0.4 • n=31 Participants
|
|
Whole Mouth Mean Clinical Attachment Loss
|
3.5 mm
STANDARD_DEVIATION 0.8 • n=99 Participants
|
3.2 mm
STANDARD_DEVIATION 0.7 • n=107 Participants
|
3.3 mm
STANDARD_DEVIATION 0.7 • n=206 Participants
|
3.3 mm
STANDARD_DEVIATION 0.5 • n=7 Participants
|
3.3 mm
STANDARD_DEVIATION 0.7 • n=31 Participants
|
|
% sites with Pocket Depth ≥ 4 mm per participant
|
24.9 % sites with PD >= 4 mm of a participant
STANDARD_DEVIATION 15.8 • n=99 Participants
|
18.7 % sites with PD >= 4 mm of a participant
STANDARD_DEVIATION 7.2 • n=107 Participants
|
21.4 % sites with PD >= 4 mm of a participant
STANDARD_DEVIATION 10.6 • n=206 Participants
|
20.2 % sites with PD >= 4 mm of a participant
STANDARD_DEVIATION 10.6 • n=7 Participants
|
21.3 % sites with PD >= 4 mm of a participant
STANDARD_DEVIATION 11.4 • n=31 Participants
|
|
Bleeding on Probing (BOP) Index per participant
|
40 BOP index of a participant
STANDARD_DEVIATION 17.2 • n=99 Participants
|
35.9 BOP index of a participant
STANDARD_DEVIATION 13.4 • n=107 Participants
|
34.9 BOP index of a participant
STANDARD_DEVIATION 11.9 • n=206 Participants
|
35.3 BOP index of a participant
STANDARD_DEVIATION 15.3 • n=7 Participants
|
36.5 BOP index of a participant
STANDARD_DEVIATION 14.3 • n=31 Participants
|
|
Plaque Index (PI) per participant
|
48.0 Plaque Index of a participant
STANDARD_DEVIATION 16.7 • n=99 Participants
|
47.1 Plaque Index of a participant
STANDARD_DEVIATION 13.7 • n=107 Participants
|
38.9 Plaque Index of a participant
STANDARD_DEVIATION 11.5 • n=206 Participants
|
40.3 Plaque Index of a participant
STANDARD_DEVIATION 14.6 • n=7 Participants
|
43.6 Plaque Index of a participant
STANDARD_DEVIATION 14.5 • n=31 Participants
|
|
Hemoglobin A1c
|
7 % of hemoglobin a1c
n=99 Participants
|
7 % of hemoglobin a1c
n=107 Participants
|
5.5 % of hemoglobin a1c
n=206 Participants
|
5.2 % of hemoglobin a1c
n=7 Participants
|
6 % of hemoglobin a1c
n=31 Participants
|
|
Fasting Blood Glucose
|
129 mg/dL
n=99 Participants
|
135 mg/dL
n=107 Participants
|
92 mg/dL
n=206 Participants
|
90 mg/dL
n=7 Participants
|
107 mg/dL
n=31 Participants
|
|
C-reactive Protein (CRP)
|
2.5 mg/L
n=99 Participants
|
1.8 mg/L
n=107 Participants
|
2.2 mg/L
n=206 Participants
|
1.2 mg/L
n=7 Participants
|
1.9 mg/L
n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsPeriodontal PD in millimeters is measured with a UNC-15 periodontal probe on 6 sites per tooth; site status is compared between timepoints measured
Outcome measures
| Measure |
Group A: SRP + SPT
n=45 Participants
The group includes patients with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
|
Group B: SRP
n=41 Participants
The group includes patients with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
|
Non-Diabetic + SRP + SPT
The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
|
Non-Diabetic + SRP
The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
|
|---|---|---|---|---|
|
Change in Probing Pocket Depth at the 6-month Post-SRP Completed at Baseline
|
-0.25 mm
Standard Deviation 0.24
|
-0.18 mm
Standard Deviation 0.2
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 3 monthsPeriodontal PD in millimeters is measured with a UNC-15 periodontal probe on 6 sites per tooth; site status is compared between timepoints measured
Outcome measures
| Measure |
Group A: SRP + SPT
n=45 Participants
The group includes patients with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
|
Group B: SRP
n=41 Participants
The group includes patients with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
|
Non-Diabetic + SRP + SPT
The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
|
Non-Diabetic + SRP
The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
|
|---|---|---|---|---|
|
Change in Probing Pocket Depth at the 3-month Post-SRP Completed at Baseline
|
-0.31 mm
Standard Deviation 0.27
|
-0.21 mm
Standard Deviation 0.22
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 3 months;Baseline to 6 monthsThe distance from the Cemento-enamel Junction (CEJ) to the free gingival margin is measured with a periodontal probe. Millimeters of recession (loss of attachment) is recorded as a negative number; when the gingival margin is above the CEJ, the measurement (in millimeters) is recorded as positive.
Outcome measures
| Measure |
Group A: SRP + SPT
n=45 Participants
The group includes patients with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
|
Group B: SRP
n=41 Participants
The group includes patients with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
|
Non-Diabetic + SRP + SPT
The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
|
Non-Diabetic + SRP
The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
|
|---|---|---|---|---|
|
Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline
Baseline to 3-month
|
-0.1 mm
Standard Deviation 0.29
|
-0.2 mm
Standard Deviation 0.29
|
—
|
—
|
|
Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline
Baseline to 6-month
|
-0.1 mm
Standard Deviation 0.25
|
-0.12 mm
Standard Deviation 0.27
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 3 months; Baseline to 6 monthsPopulation: For each participant, 6 sites per tooth are evaluated. The measured sites within each participant were summarized to access the outcome in each participant. The analysis is based on participants.
The analysis is based on the measures of each participant. Participant instead of site is used as unite for arm/group. The measure, % sites with probing pocket depth \>= 4 mm within each participant, indicates the portion of deep pocket in a participant. Periodontal PD in millimeters is measured with a UNC-15 periodontal probe on 6 sites per tooth; The percentage of sites with Periodontal PD \>= 4 mm within each participant was compared between measured time points.
Outcome measures
| Measure |
Group A: SRP + SPT
n=45 Participants
The group includes patients with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
|
Group B: SRP
n=41 Participants
The group includes patients with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
|
Non-Diabetic + SRP + SPT
The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
|
Non-Diabetic + SRP
The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
|
|---|---|---|---|---|
|
Change in % Sites With Probing Pocket Depth >= 4 mm of a Participant at the 3, 6 Months Post-SRP Completed at Baseline
Baseline to 3-month
|
-8.71 % sites with PD >= 4 mm of a participant
Standard Deviation 7.03
|
-4.74 % sites with PD >= 4 mm of a participant
Standard Deviation 5.1
|
—
|
—
|
|
Change in % Sites With Probing Pocket Depth >= 4 mm of a Participant at the 3, 6 Months Post-SRP Completed at Baseline
Baseline to 6-month
|
-7.03 % sites with PD >= 4 mm of a participant
Standard Deviation 6.72
|
-4.73 % sites with PD >= 4 mm of a participant
Standard Deviation 5.35
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 3 months; Baseline to 6 monthsPopulation: For each participant, 6 sites per tooth are evaluated. The measured sites within each participant were summarized to access the outcome in each participant. The analysis is based on participants.
The analysis is based on the measures of each participant. 0 is the absence of gingival bleeding and 1 is the presence of gingival bleeding after probing and measuring for pocket depth. Bleeding on probing index is defined as the percentage of sites with presence of gingival bleeding after probing per participant. The value of bleeding on probing index ranges from 0 to 100 for each participant. The bleeding on probing index per participant is compared between time points measured.
Outcome measures
| Measure |
Group A: SRP + SPT
n=45 Participants
The group includes patients with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
|
Group B: SRP
n=41 Participants
The group includes patients with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
|
Non-Diabetic + SRP + SPT
The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
|
Non-Diabetic + SRP
The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
|
|---|---|---|---|---|
|
Changes in Bleeding on Probing (BOP) Index of a Participant at 3, 6 Months After Treatment at Baseline
Baseline to 3 months
|
-13.24 BOP index of a participant
Standard Deviation 9.69
|
-5.57 BOP index of a participant
Standard Deviation 10.1
|
—
|
—
|
|
Changes in Bleeding on Probing (BOP) Index of a Participant at 3, 6 Months After Treatment at Baseline
Baseline to 6 months
|
-8.93 BOP index of a participant
Standard Deviation 10.76
|
-4.09 BOP index of a participant
Standard Deviation 9.22
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 3 months; Baseline to 6 monthsPopulation: For each participant, 6 sites per tooth are evaluated. The measured sites within each participant were summarized to access the outcome in each participant. The analysis is based on participants.
The analysis is based on the measures of each participant. Plaque is visually measured on 6 sites per tooth; 0 is the absence of any plaque. 1 is the presence of plaque. For each participant, 6 sites per tooth are evaluated. The Plaque Index (PI) of each participant is defined as the percentage of sites with plaque. The value of PI ranges from 0 to 100 for each participant. The PI of each participant is assessed and compared between measured time points.
Outcome measures
| Measure |
Group A: SRP + SPT
n=45 Participants
The group includes patients with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
|
Group B: SRP
n=41 Participants
The group includes patients with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
|
Non-Diabetic + SRP + SPT
The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
|
Non-Diabetic + SRP
The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
|
|---|---|---|---|---|
|
Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline
Baseline to 3 months
|
-14.76 Plaque Index of a participant
Standard Deviation 11.52
|
-7.7 Plaque Index of a participant
Standard Deviation 12.5
|
—
|
—
|
|
Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline
Baseline to 6 months
|
9.68 Plaque Index of a participant
Standard Deviation 12.22
|
-5.19 Plaque Index of a participant
Standard Deviation 12.08
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 3 months; Baseline to 6 monthsProbing depth (PD) or probing pocket depth (PPD), measured on six surfaces/tooth, is the distance in millimeters (mm) from the gingival margin to the base of the gingival pocket
Outcome measures
| Measure |
Group A: SRP + SPT
n=21 Participants
The group includes patients with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
|
Group B: SRP
n=23 Participants
The group includes patients with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
|
Non-Diabetic + SRP + SPT
n=24 Participants
The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
|
Non-Diabetic + SRP
n=18 Participants
The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
|
|---|---|---|---|---|
|
Change in Probing Pocket Depth at 3, 6 Months After Treatment in Diabetics and Non-diabetics
Baseline to 3-month
|
-0.36 mm
Standard Deviation 0.29
|
-0.17 mm
Standard Deviation 0.17
|
-0.26 mm
Standard Deviation 0.24
|
-0.27 mm
Standard Deviation 0.26
|
|
Change in Probing Pocket Depth at 3, 6 Months After Treatment in Diabetics and Non-diabetics
Baseline to 6-month
|
-0.27 mm
Standard Deviation 0.27
|
-0.12 mm
Standard Deviation 0.19
|
-0.24 mm
Standard Deviation 0.21
|
-0.26 mm
Standard Deviation 0.19
|
SECONDARY outcome
Timeframe: Baseline to 3 months; Baseline to 6 monthsThe distance from the Cemento-enamel Junction (CEJ) to the free gingival margin is measured with a periodontal probe. Millimeters of recession (loss of attachment) is recorded as a negative number; when the gingival margin is above the CEJ, the measurement (in millimeters) is recorded as positive.
Outcome measures
| Measure |
Group A: SRP + SPT
n=21 Participants
The group includes patients with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
|
Group B: SRP
n=23 Participants
The group includes patients with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
|
Non-Diabetic + SRP + SPT
n=24 Participants
The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
|
Non-Diabetic + SRP
n=18 Participants
The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
|
|---|---|---|---|---|
|
Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics
Baseline to 3 months
|
-0.11 mm
Standard Deviation 0.28
|
-0.17 mm
Standard Deviation 0.25
|
-0.1 mm
Standard Deviation 0.31
|
-0.23 mm
Standard Deviation 0.33
|
|
Changes in Clinical Attachment Level at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics
Baseline to 6 months
|
-0.14 mm
Standard Deviation 0.24
|
-0.06 mm
Standard Deviation 0.24
|
-0.07 mm
Standard Deviation 0.26
|
-0.19 mm
Standard Deviation 0.29
|
SECONDARY outcome
Timeframe: Baseline to 3 months; Baseline to 6 monthsPopulation: For each participant, 6 sites per tooth are evaluated. The measured sites within each participant were summarized to access the outcome in each participant. The analysis is based on participants.
The analysis is based on the measure of each participant. Periodontal PD in millimeters is measured with a UNC-15 periodontal probe on 6 sites per tooth; The percentage of sites with Periodontal PD \>= 4 mm per participant is compared between measured time points.
Outcome measures
| Measure |
Group A: SRP + SPT
n=21 Participants
The group includes patients with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
|
Group B: SRP
n=23 Participants
The group includes patients with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
|
Non-Diabetic + SRP + SPT
n=24 Participants
The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
|
Non-Diabetic + SRP
n=18 Participants
The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
|
|---|---|---|---|---|
|
Change in % Sites With Probing Pocket Depth >= 4 mm of a Participant at the 3, 6 Months Post-SRP Completed at Baseline in Diabetics and Non-diabetics
Baseline to 3-month
|
-10.23 % sites with PD >= 4 mm of a participant
Standard Deviation 7.88
|
-4.22 % sites with PD >= 4 mm of a participant
Standard Deviation 4.22
|
-7.39 % sites with PD >= 4 mm of a participant
Standard Deviation 6.05
|
-5.4 % sites with PD >= 4 mm of a participant
Standard Deviation 6.12
|
|
Change in % Sites With Probing Pocket Depth >= 4 mm of a Participant at the 3, 6 Months Post-SRP Completed at Baseline in Diabetics and Non-diabetics
Baseline to 6-month
|
-7.85 % sites with PD >= 4 mm of a participant
Standard Deviation 8.02
|
4.12 % sites with PD >= 4 mm of a participant
Standard Deviation 5.55
|
-6.3 % sites with PD >= 4 mm of a participant
Standard Deviation 5.41
|
-5.52 % sites with PD >= 4 mm of a participant
Standard Deviation 5.13
|
SECONDARY outcome
Timeframe: Baseline to 3 months; Baseline to 6 monthsPopulation: For each participant, 6 sites per tooth are evaluated. The measured sites within each participant were summarized to access the outcome in each participant. The analysis is based on participants.
The analysis is based on the measures of each participant. 0 is the absence of gingival bleeding and 1 is the presence of gingival bleeding after probing and measuring for pocket depth. Bleeding on probing index is defined as the percentage of sites with presence of gingival bleeding after probing per participant. The value of bleeding on probing index ranges from 0 to 100 for each participant. The bleeding on probing index per participant is compared between time points measured.
Outcome measures
| Measure |
Group A: SRP + SPT
n=21 Participants
The group includes patients with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
|
Group B: SRP
n=23 Participants
The group includes patients with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
|
Non-Diabetic + SRP + SPT
n=24 Participants
The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
|
Non-Diabetic + SRP
n=18 Participants
The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
|
|---|---|---|---|---|
|
Changes in Bleeding on Probing (BOP) Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics
Baseline to 3 months
|
-13.45 BOP index of a participant
Standard Deviation 11.31
|
-4.35 BOP index of a participant
Standard Deviation 10.62
|
-13.06 BOP index of a participant
Standard Deviation 8.27
|
-7.13 BOP index of a participant
Standard Deviation 9.45
|
|
Changes in Bleeding on Probing (BOP) Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics
Baseline to 6 months
|
-9.62 BOP index of a participant
Standard Deviation 13.34
|
-1.95 BOP index of a participant
Standard Deviation 8.83
|
-8.32 BOP index of a participant
Standard Deviation 8.12
|
-6.82 BOP index of a participant
Standard Deviation 9.23
|
SECONDARY outcome
Timeframe: Baseline to 3 months; Baseline to 6 monthsPopulation: For each participant, 6 sites per tooth are evaluated. The measured sites within each participant were summarized to access the outcome in each participant. The analysis is based on participants.
The analysis is based on the measures of each participant. Plaque is visually measured on 6 sites per tooth; 0 is the absence of any plaque. 1 is the presence of plaque. For each participant, 6 sites per tooth are evaluated. The Plaque Index (PI) of each participant is defined as the percentage of sites with plaque. The value of PI ranges from 0 to 100 for each participant. The PI of each participant is assessed and compared between measured time points.
Outcome measures
| Measure |
Group A: SRP + SPT
n=21 Participants
The group includes patients with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
|
Group B: SRP
n=23 Participants
The group includes patients with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
|
Non-Diabetic + SRP + SPT
n=24 Participants
The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
|
Non-Diabetic + SRP
n=18 Participants
The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
|
|---|---|---|---|---|
|
Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics
Baseline to 3 months
|
-17.46 Plaque Index of a participant
Standard Deviation 13.19
|
-7.67 Plaque Index of a participant
Standard Deviation 13.16
|
-12.4 Plaque Index of a participant
Standard Deviation 9.48
|
-7.75 Plaque Index of a participant
Standard Deviation 11.99
|
|
Change in Plaque Index of a Participant at 3, 6 Months After Treatment at Baseline in Diabetics and Non-diabetics
Baseline to 6 months
|
-12.11 Plaque Index of a participant
Standard Deviation 14.05
|
-4.97 Plaque Index of a participant
Standard Deviation 12.43
|
-7.56 Plaque Index of a participant
Standard Deviation 10.18
|
-5.48 Plaque Index of a participant
Standard Deviation 11.96
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsHemoglobin in A1c (HbA1c) tells the average level of blood sugar over the prior 2 to 3 months. Normal level is below 5.7%; 5.7%-6.4% indicates prediabetes; greater than 6.5% is indicative of diabetes.
Outcome measures
| Measure |
Group A: SRP + SPT
n=45 Participants
The group includes patients with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
|
Group B: SRP
n=41 Participants
The group includes patients with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
|
Non-Diabetic + SRP + SPT
The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
|
Non-Diabetic + SRP
The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
|
|---|---|---|---|---|
|
Changes in Hemoglobin A1c at 6 Months After Treatment
|
-0.01 % of hemoglobin a1c
Standard Deviation 0.55
|
0.14 % of hemoglobin a1c
Standard Deviation 0.72
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsFasting blood sugar/glucose (FBS/FBG) is tested with a blood sample taken after an overnight fast. A fasting blood sugar level less than 100 mg/dL is normal; a fasting blood sugar level from 100 to 125 mg/dL is considered prediabetes; a level 126 mg/dL (7 mmol/L) or higher on two separate tests, indicates diabetes.
Outcome measures
| Measure |
Group A: SRP + SPT
n=45 Participants
The group includes patients with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
|
Group B: SRP
n=41 Participants
The group includes patients with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
|
Non-Diabetic + SRP + SPT
The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
|
Non-Diabetic + SRP
The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
|
|---|---|---|---|---|
|
Changes in Fasting Blood Glucose at 6 Months After Treatment
|
-2.13 mg/dL
Standard Deviation 32.30
|
1.85 mg/dL
Standard Deviation 34.68
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsThe high-sensitivity C-reactive protein (hs-CRP) blood test measures body inflammation indicating infection or a chronic inflammatory disease such as periodontitis or diabetes. It also can be used to evaluate risk of developing coronary artery disease. A normal reading is less than 10 milligram per liter (mg/L); a level greater than 10 mg/L is a sign of serious infection, trauma or chronic disease likely requiring further testing to determine cause
Outcome measures
| Measure |
Group A: SRP + SPT
n=45 Participants
The group includes patients with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
|
Group B: SRP
n=41 Participants
The group includes patients with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
|
Non-Diabetic + SRP + SPT
The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
|
Non-Diabetic + SRP
The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
|
|---|---|---|---|---|
|
Change in High Sensitivity C-reactive Protein at 6 Months After Treatment
|
-0.33 mg/L
Standard Deviation 4.31
|
-1.25 mg/L
Standard Deviation 8.84
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsHemoglobin in A1c (HbA1c) tells the average level of blood sugar over the prior 2 to 3 months. Normal level is below 5.7%; 5.7%-6.4% indicates prediabetes; greater than 6.5% is indicative of diabetes.
Outcome measures
| Measure |
Group A: SRP + SPT
n=21 Participants
The group includes patients with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
|
Group B: SRP
n=23 Participants
The group includes patients with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
|
Non-Diabetic + SRP + SPT
n=24 Participants
The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
|
Non-Diabetic + SRP
n=18 Participants
The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
|
|---|---|---|---|---|
|
Changes in Hemoglobin A1c at 6 Months After Treatment in Diabetics and Non-diabetics
|
-0.04 % of hemoglobin a1c
Standard Deviation 0.79
|
0.30 % of hemoglobin a1c
Standard Deviation 0.92
|
0.01 % of hemoglobin a1c
Standard Deviation 0.18
|
-0.07 % of hemoglobin a1c
Standard Deviation 0.20
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsFasting blood sugar/glucose (FBS/FBG) is tested with a blood sample taken after an overnight fast. A fasting blood sugar level less than 100 mg/dL is normal; a fasting blood sugar level from 100 to 125 mg/dL is considered prediabetes; a level 126 mg/dL (7 mmol/L) or higher on two separate tests, indicates diabetes.
Outcome measures
| Measure |
Group A: SRP + SPT
n=21 Participants
The group includes patients with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
|
Group B: SRP
n=23 Participants
The group includes patients with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
|
Non-Diabetic + SRP + SPT
n=24 Participants
The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
|
Non-Diabetic + SRP
n=18 Participants
The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
|
|---|---|---|---|---|
|
Changes in Fasting Blood Glucose at 6 Months After Treatment in Diabetics and Non-diabetics
|
-5.05 mg/dL
Standard Deviation 46.99
|
2.74 mg/dL
Standard Deviation 46.04
|
0.42 mg/dL
Standard Deviation 7.78
|
0.72 mg/dL
Standard Deviation 9.22
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsThe high-sensitivity C-reactive protein (hs-CRP) blood test measures body inflammation indicating infection or a chronic inflammatory disease such as periodontitis or diabetes. It also can be used to evaluate risk of developing coronary artery disease. A normal reading is less than 10 milligram per liter (mg/L); a level greater than 10 mg/L is a sign of serious infection, trauma or chronic disease likely requiring further testing to determine cause
Outcome measures
| Measure |
Group A: SRP + SPT
n=21 Participants
The group includes patients with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
|
Group B: SRP
n=23 Participants
The group includes patients with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
|
Non-Diabetic + SRP + SPT
n=24 Participants
The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
|
Non-Diabetic + SRP
n=18 Participants
The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
|
|---|---|---|---|---|
|
Change in High Sensitivity C-reactive Protein at 6 Months After Treatment in Diabetics and Non-diabetics
|
0.23 mg/L
Standard Deviation 2.11
|
-2.23 mg/L
Standard Deviation 11.82
|
-0.41 mg/L
Standard Deviation 5.57
|
0.01 mg/L
Standard Deviation 0.56
|
SECONDARY outcome
Timeframe: Baseline; 6 MonthsShannon index represents mean species diversity in a site at a local scale. Shannon index quantifies the uncertainty in predicting the species identity of an individual that is taken at random from the dataset. The minimum value is 0 and there is no maximum value. High values mean high species diversities.
Outcome measures
| Measure |
Group A: SRP + SPT
n=45 Participants
The group includes patients with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
|
Group B: SRP
n=41 Participants
The group includes patients with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
|
Non-Diabetic + SRP + SPT
The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
|
Non-Diabetic + SRP
The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
|
|---|---|---|---|---|
|
Shannon Index of the Subgingival Plaque Microbiome at Baseline and 6 Months
Baseline
|
5.31 Shannon index value
Standard Deviation 0.48
|
5.27 Shannon index value
Standard Deviation 0.55
|
—
|
—
|
|
Shannon Index of the Subgingival Plaque Microbiome at Baseline and 6 Months
6 Months
|
5.2 Shannon index value
Standard Deviation 0.5
|
5.34 Shannon index value
Standard Deviation 0.5
|
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|
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|
SECONDARY outcome
Timeframe: Baseline to 6 MonthsAnalysis of microbiome community changes using the healthy plane (HP) as a reference. A healthy plane was calculated by fitting a plane that minimizes the sum of squares of distances from HC samples to the nearest point on the plane. The distance of each sample to the HP was then calculated. Higher values of distance to HP mean microbiome community changes towards disease status
Outcome measures
| Measure |
Group A: SRP + SPT
n=45 Participants
The group includes patients with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
|
Group B: SRP
n=41 Participants
The group includes patients with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
|
Non-Diabetic + SRP + SPT
The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling \& root planing plus supportive periodontal therapy (SPT) chlorhexidine gluconate (Paroex®) mouthrinse + Soft-Picks.
Chlorhexidine gluconate oral rinse: Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
Soft Picks: Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
|
Non-Diabetic + SRP
The group includes non-diabetics with periodontal disease; they will receive standard therapy, scaling and root planing (SRP).
Scaling \& Root Planing: SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
|
|---|---|---|---|---|
|
Change in Distance to the Healthy Plane Based on the Subgingival Plaque Microbiome at 6 Months
|
-2.16 distance to the healthy plane
Standard Deviation 5.84
|
-1.26 distance to the healthy plane
Standard Deviation 7.37
|
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|
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|
Adverse Events
Diabetic + SRP + SPT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Diabetic + SRP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-Diabetic + SRP + SPT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-Diabetic + SRP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place