Trial Outcomes & Findings for Role of Infected Blood Dendritic Cells in Heart Disease Risk (NCT NCT01568944)
NCT ID: NCT01568944
Last Updated: 2020-05-12
Results Overview
The frequency of blood dendritic cells, i.e. % CCR6+CD1a+ DCs by flow cytometry 30 days after treatment with 7 day regimen of antibiotics, mouthrinse therapy and scaling and root planing (SRP) will be compared to those who did not receive the antibiotics, but did receive mouthrinse and scaling and root planing (SRP)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
30 days
Results posted on
2020-05-12
Participant Flow
Participant milestones
| Measure |
Oral Antibiotic and Oral Rinse
Each subject will received oral Amoxicillin/Amoxil/lansoprazole/Flagyl 250 mg of each three times a day for 8 days. Subjects will also rinse their mouths with 2 ounces of 0.12% chlorhexidine/peridex mouthrinse two times per day. Subjects will also receive mechanical debridement at the baseline visit. Intervention Amoxicillin/Amoxil/lansoprazol 500 mg/ Metronidazole/Flagyl 250 mg
Oral Antibiotic and Oral Rinse: PO Amoxicillin in 500 mg / Metronidazole 250 mg of each TID for 8 days plus 2 ounces of 0.12% chlorhexidine mouthrinse used BID
Standard Treatment: Full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers
|
Standard Treatment
Subjects assigned to standard treatment will receive full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers
Standard Treatment: Full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
10
|
|
Overall Study
COMPLETED
|
8
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Role of Infected Blood Dendritic Cells in Heart Disease Risk
Baseline characteristics by cohort
| Measure |
Oral Antibiotic and Oral Rinse
n=8 Participants
Each subject will received oral Amoxicillin/Amoxil/lansoprazole/Flagyl 250 mg of each three times a day for 8 days. Subjects will also rinse their mouths with 2 ounces of 0.12% chlorhexidine/peridex mouthrinse two times per day. Subjects will also receive mechanical debridement at the baseline visit. Intervention Amoxicillin/Amoxil/lansoprazol 500 mg/ Metronidazole/Flagyl 250 mg
Oral Antibiotic and Oral Rinse: PO Amoxicillin in 500 mg / Metronidazole 250 mg of each TID for 8 days plus 2 ounces of 0.12% chlorhexidine mouthrinse used BID
Standard Treatment: Full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers
|
Standard Treatment
n=10 Participants
Subjects assigned to standard treatment will receive full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers
Standard Treatment: Full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 4 • n=99 Participants
|
48 years
STANDARD_DEVIATION 5 • n=107 Participants
|
46 years
STANDARD_DEVIATION 4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=99 Participants
|
10 participants
n=107 Participants
|
18 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 30 daysThe frequency of blood dendritic cells, i.e. % CCR6+CD1a+ DCs by flow cytometry 30 days after treatment with 7 day regimen of antibiotics, mouthrinse therapy and scaling and root planing (SRP) will be compared to those who did not receive the antibiotics, but did receive mouthrinse and scaling and root planing (SRP)
Outcome measures
| Measure |
Oral Antibiotic and Oral Rinse
n=8 Participants
Each subject will received oral Amoxicillin/Amoxil/lansoprazole/Flagyl 250 mg of each three times a day for 8 days. Subjects will also rinse their mouths with 2 ounces of 0.12% chlorhexidine/peridex mouthrinse two times per day. Subjects will also receive mechanical debridement at the baseline visit. Intervention Amoxicillin/Amoxil/lansoprazol 500 mg/ Metronidazole/Flagyl 250 mg
Oral Antibiotic and Oral Rinse: PO Amoxicillin in 500 mg / Metronidazole 250 mg of each TID for 8 days plus 2 ounces of 0.12% chlorhexidine mouthrinse used BID
Standard Treatment: Full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers
|
Standard Treatment
n=10 Participants
Subjects assigned to standard treatment will receive full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers
Standard Treatment: Full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers
|
|---|---|---|
|
Frequency of Blood Dendritic Cells From Baseline
|
12 % MFI
Standard Deviation 4
|
14 % MFI
Standard Deviation 2
|
SECONDARY outcome
Timeframe: 30 daysPopulation: The number of teeth
Probing attachment levels (distance from the cemento-enamel junction to the base of the periodontal pocket in mm at 6 sites p\[er tooth) will be monitored after 30 days
Outcome measures
| Measure |
Oral Antibiotic and Oral Rinse
n=32 tooth sites
Each subject will received oral Amoxicillin/Amoxil/lansoprazole/Flagyl 250 mg of each three times a day for 8 days. Subjects will also rinse their mouths with 2 ounces of 0.12% chlorhexidine/peridex mouthrinse two times per day. Subjects will also receive mechanical debridement at the baseline visit. Intervention Amoxicillin/Amoxil/lansoprazol 500 mg/ Metronidazole/Flagyl 250 mg
Oral Antibiotic and Oral Rinse: PO Amoxicillin in 500 mg / Metronidazole 250 mg of each TID for 8 days plus 2 ounces of 0.12% chlorhexidine mouthrinse used BID
Standard Treatment: Full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers
|
Standard Treatment
n=32 tooth sites
Subjects assigned to standard treatment will receive full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers
Standard Treatment: Full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers
|
|---|---|---|
|
Probing Attachment Levels
|
4.2 mm
Standard Deviation 6
|
4.6 mm
Standard Deviation 4
|
SECONDARY outcome
Timeframe: 30 daysPopulation: CCL20 in pg/ml of serum will be measured by ELISA
serum CCL20 in pg/ml by ELISA will be measured after 30 days
Outcome measures
| Measure |
Oral Antibiotic and Oral Rinse
n=8 Participants
Each subject will received oral Amoxicillin/Amoxil/lansoprazole/Flagyl 250 mg of each three times a day for 8 days. Subjects will also rinse their mouths with 2 ounces of 0.12% chlorhexidine/peridex mouthrinse two times per day. Subjects will also receive mechanical debridement at the baseline visit. Intervention Amoxicillin/Amoxil/lansoprazol 500 mg/ Metronidazole/Flagyl 250 mg
Oral Antibiotic and Oral Rinse: PO Amoxicillin in 500 mg / Metronidazole 250 mg of each TID for 8 days plus 2 ounces of 0.12% chlorhexidine mouthrinse used BID
Standard Treatment: Full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers
|
Standard Treatment
n=10 Participants
Subjects assigned to standard treatment will receive full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers
Standard Treatment: Full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers
|
|---|---|---|
|
Serum Cytokine Response
|
22 pg/ml
Standard Deviation 5
|
32 pg/ml
Standard Deviation 5
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Probing depths in mm at 192 sites per patient
Probing depths (distance from the free gingival margin to the base of the pocket in mm at six sites per tooth) will be monitored after 30 days
Outcome measures
| Measure |
Oral Antibiotic and Oral Rinse
n=192 sites per mouth
Each subject will received oral Amoxicillin/Amoxil/lansoprazole/Flagyl 250 mg of each three times a day for 8 days. Subjects will also rinse their mouths with 2 ounces of 0.12% chlorhexidine/peridex mouthrinse two times per day. Subjects will also receive mechanical debridement at the baseline visit. Intervention Amoxicillin/Amoxil/lansoprazol 500 mg/ Metronidazole/Flagyl 250 mg
Oral Antibiotic and Oral Rinse: PO Amoxicillin in 500 mg / Metronidazole 250 mg of each TID for 8 days plus 2 ounces of 0.12% chlorhexidine mouthrinse used BID
Standard Treatment: Full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers
|
Standard Treatment
n=192 sites per mouth
Subjects assigned to standard treatment will receive full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers
Standard Treatment: Full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers
|
|---|---|---|
|
Probing Depths
|
4.2 mm
Standard Deviation 3
|
4.7 mm
Standard Deviation 4
|
SECONDARY outcome
Timeframe: 30 daysPopulation: plaque index at 64 sites per mouth will be measured
Plaque index of Silness and Loe will be monitored at buccal and lingual surfaces of all teeth after 30 days: 0 no visible microbial plaque 1. thin film of visible microbial plaque in sulcus 2. moderate accumulation of plaque in sulcus 3. large amount of plaque in sulcus or along free gingival margin
Outcome measures
| Measure |
Oral Antibiotic and Oral Rinse
n=64 sites per mouth
Each subject will received oral Amoxicillin/Amoxil/lansoprazole/Flagyl 250 mg of each three times a day for 8 days. Subjects will also rinse their mouths with 2 ounces of 0.12% chlorhexidine/peridex mouthrinse two times per day. Subjects will also receive mechanical debridement at the baseline visit. Intervention Amoxicillin/Amoxil/lansoprazol 500 mg/ Metronidazole/Flagyl 250 mg
Oral Antibiotic and Oral Rinse: PO Amoxicillin in 500 mg / Metronidazole 250 mg of each TID for 8 days plus 2 ounces of 0.12% chlorhexidine mouthrinse used BID
Standard Treatment: Full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers
|
Standard Treatment
n=64 sites per mouth
Subjects assigned to standard treatment will receive full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers
Standard Treatment: Full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers
|
|---|---|---|
|
Plaque Index
|
2 pI index
Interval 0.0 to 3.0
|
3 pI index
Interval 1.0 to 3.0
|
SECONDARY outcome
Timeframe: 30 daysPopulation: gingival index at 3 sites per tooth
Gingival index of Loe and Silness on facial, lingual and mesial surfaces of all teeth will be monitored after 30 days: 0 Normal, no inflammation 1. Mild inflammation, slight color change and edema, no bleeding 2. Moderate inflammation, redness, edema, bleeds on probing 3. Severe inflammation, marked redness and edema ulceration, spontaneous bleeding
Outcome measures
| Measure |
Oral Antibiotic and Oral Rinse
n=96 3 sites per tooth
Each subject will received oral Amoxicillin/Amoxil/lansoprazole/Flagyl 250 mg of each three times a day for 8 days. Subjects will also rinse their mouths with 2 ounces of 0.12% chlorhexidine/peridex mouthrinse two times per day. Subjects will also receive mechanical debridement at the baseline visit. Intervention Amoxicillin/Amoxil/lansoprazol 500 mg/ Metronidazole/Flagyl 250 mg
Oral Antibiotic and Oral Rinse: PO Amoxicillin in 500 mg / Metronidazole 250 mg of each TID for 8 days plus 2 ounces of 0.12% chlorhexidine mouthrinse used BID
Standard Treatment: Full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers
|
Standard Treatment
n=96 3 sites per tooth
Subjects assigned to standard treatment will receive full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers
Standard Treatment: Full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers
|
|---|---|---|
|
Gingival Index
|
2 GI
Interval 1.0 to 3.0
|
3 GI
Interval 2.0 to 4.0
|
Adverse Events
Oral Antibiotic and Oral Rinse
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Treatment
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