Trial Outcomes & Findings for Iranian Traditional Mouth Rinse Punica Granatum Pleniflora (Golnaar) in Treatment of Gingivitis in Diabetic Patients (NCT NCT02227485)
NCT ID: NCT02227485
Last Updated: 2016-08-24
Results Overview
0 No plaque 1. A film of plaque adhering to the free gingival margin and adjacent area of the tooth, which cannot be seen with the naked eye. But only by using disclosing solution or by using probe. 2. Moderate accumulation of deposits within the gingival pocket, on the gingival margin and/ or adjacent tooth surface, which can be seen with the naked eye. 3. Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
COMPLETED
NA
80 participants
At the beginning, after 2 weeks and after 4 weeks
2016-08-24
Participant Flow
Recruitment for Chlorhexidine group started on 11/05/2014 and ended on 07/11/2014. For Golnaar group the starting and ending dates were; 01/05/2014 and 09/11/2014.
Participant milestones
| Measure |
Chlorhexidine (0.2%)
Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses.
|
Punica Granatum Pleniflora Mouth Rinse
Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of "Golnaar" mouth rinse for 2 minutes every night for 2 weeks.
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses.
|
|---|---|---|
|
First Follow-up
STARTED
|
40
|
40
|
|
First Follow-up
COMPLETED
|
36
|
38
|
|
First Follow-up
NOT COMPLETED
|
4
|
2
|
|
Second Follow-up
STARTED
|
36
|
38
|
|
Second Follow-up
COMPLETED
|
34
|
36
|
|
Second Follow-up
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Iranian Traditional Mouth Rinse Punica Granatum Pleniflora (Golnaar) in Treatment of Gingivitis in Diabetic Patients
Baseline characteristics by cohort
| Measure |
Chlorhexidine (0.2%)
n=40 Participants
Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
Chlorhexidine (0.2%): All the patients in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses.
|
Punica Granatum Pleniflora Mouth Rinse
n=40 Participants
Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
Punica granatum Pleniflora (Golnaar) mouth rinse: All the patients in intervention group use 10 ml of "Golnaar" mouth rinse for 2 minutes every night for 2 weeks.
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.3 years
STANDARD_DEVIATION 6.5 • n=99 Participants
|
50.35 years
STANDARD_DEVIATION 6.9 • n=107 Participants
|
51.33 years
STANDARD_DEVIATION 6.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Region of Enrollment
Iran, Islamic Republic of
|
40 participants
n=99 Participants
|
40 participants
n=107 Participants
|
80 participants
n=206 Participants
|
|
Height
|
163.9 cm
STANDARD_DEVIATION 9.6 • n=99 Participants
|
164.1 cm
STANDARD_DEVIATION 10.0 • n=107 Participants
|
164 cm
STANDARD_DEVIATION 9.7 • n=206 Participants
|
|
Weight
|
75.1 kg
STANDARD_DEVIATION 13.5 • n=99 Participants
|
75.6 kg
STANDARD_DEVIATION 13.8 • n=107 Participants
|
75.4 kg
STANDARD_DEVIATION 13.6 • n=206 Participants
|
|
Disease duration
|
10.3 years
STANDARD_DEVIATION 6.2 • n=99 Participants
|
9.7 years
STANDARD_DEVIATION 6.3 • n=107 Participants
|
10 years
STANDARD_DEVIATION 6.2 • n=206 Participants
|
|
Teeth number
|
24.7 teeth
STANDARD_DEVIATION 3.3 • n=99 Participants
|
25.0 teeth
STANDARD_DEVIATION 3.6 • n=107 Participants
|
24.9 teeth
STANDARD_DEVIATION 3.4 • n=206 Participants
|
|
BP
|
12.3 mm Hg
STANDARD_DEVIATION 1 • n=99 Participants
|
12.5 mm Hg
STANDARD_DEVIATION 1.2 • n=107 Participants
|
12.4 mm Hg
STANDARD_DEVIATION 1.1 • n=206 Participants
|
PRIMARY outcome
Timeframe: At the beginning, after 2 weeks and after 4 weeksPopulation: The number of analysed cases for the base line section are 40 and for other sections (after 2 weeks and 4 weeks) are 34 for Chlorhexidine group and 36 for Punica granatum group.
0 No plaque 1. A film of plaque adhering to the free gingival margin and adjacent area of the tooth, which cannot be seen with the naked eye. But only by using disclosing solution or by using probe. 2. Moderate accumulation of deposits within the gingival pocket, on the gingival margin and/ or adjacent tooth surface, which can be seen with the naked eye. 3. Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
Outcome measures
| Measure |
Chlorhexidine (0.2%)
n=40 Participants
Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (2%) for 2 minutes every night for 2 weeks.
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses.
|
Punica Granatum Pleniflora Mouth Rinse
n=40 Participants
Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of "Golnaar" mouth rinse for 2 minutes every night for 2 weeks.
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses.
|
|---|---|---|
|
Plaque Index
At base line
|
2.3 units on a scale
Standard Deviation 0.9
|
2.5 units on a scale
Standard Deviation 0.6
|
|
Plaque Index
After 2 weeks
|
1.9 units on a scale
Standard Deviation 1
|
2 units on a scale
Standard Deviation 0.7
|
|
Plaque Index
After 4 weeks
|
0.2 units on a scale
Standard Deviation 0.2
|
0.2 units on a scale
Standard Deviation 0.1
|
PRIMARY outcome
Timeframe: At the beginning, after 2 weeks and after 4 weeks.Population: The number of analysed cases for the base line section are 40 and for other sections (after 2 weeks and 4 weeks) are 34 for Chlorhexidine group and 36 for Punica granatum group.
presence of bleeding of the gum when probing it: 0= No bleeding 1= Bleeding occurs within 10 seconds after gentle probing of the orifice of the gingival crevice
Outcome measures
| Measure |
Chlorhexidine (0.2%)
n=40 Participants
Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (2%) for 2 minutes every night for 2 weeks.
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses.
|
Punica Granatum Pleniflora Mouth Rinse
n=40 Participants
Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of "Golnaar" mouth rinse for 2 minutes every night for 2 weeks.
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses.
|
|---|---|---|
|
Bleeding Index
At base line
|
0.133 units on a scale
Standard Deviation 0.097
|
0.148 units on a scale
Standard Deviation 0.123
|
|
Bleeding Index
After 2 weeks
|
0.039 units on a scale
Standard Deviation 0.057
|
0.034 units on a scale
Standard Deviation 0.056
|
|
Bleeding Index
After 4 weeks
|
0.01 units on a scale
Standard Deviation 0.034
|
0.016 units on a scale
Standard Deviation 0.03
|
PRIMARY outcome
Timeframe: At the beginning, after 2 weeks and after 4 weeksPopulation: The number of analysed cases for the base line section are 40 and for other sections (after 2 weeks and 4 weeks) are 34 for Chlorhexidine group and 36 for Punica granatum group.
It is the depth of the dental sulcus which detected by measuring the depth of sulcular insertion of the probe at six sites; mesiofacial, midfacial, distofacial, mesiolingual, midlingual and distolingual of all teeth divided by the teeth number. the measurement unit is millimeter (mm).
Outcome measures
| Measure |
Chlorhexidine (0.2%)
n=40 Participants
Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (2%) for 2 minutes every night for 2 weeks.
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses.
|
Punica Granatum Pleniflora Mouth Rinse
n=40 Participants
Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of "Golnaar" mouth rinse for 2 minutes every night for 2 weeks.
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses.
|
|---|---|---|
|
Pocket Depth
At base line
|
1.3 mm
Standard Deviation 0.8
|
1.6 mm
Standard Deviation 1.1
|
|
Pocket Depth
After 2 weeks
|
0.9 mm
Standard Deviation 0.7
|
0.8 mm
Standard Deviation 0.8
|
|
Pocket Depth
After 4 weeks
|
0.6 mm
Standard Deviation 0.6
|
0.6 mm
Standard Deviation 0.7
|
PRIMARY outcome
Timeframe: At the beginning, after 2 weeks and after 4 weeks.Population: The number of analysed cases for the base line section are 40 and for other sections (after 2 weeks and 4 weeks) are 34 for Chlorhexidine group and 36 for Punica granatum group.
0= Absence of inflammation 1. Mild inflammation or with slight changes in color and texture but not in all portions of gingival marginal or papillary 2. Mild inflammation, such as the preceding criteria, in all portions of gingival marginal or papillary 3. moderate, bright surface inflammation, erythema, edema and/or hypertrophy of gingival marginal or papillary 4. severe inflammation: erythema, edema and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion or ulceration
Outcome measures
| Measure |
Chlorhexidine (0.2%)
n=40 Participants
Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (2%) for 2 minutes every night for 2 weeks.
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses.
|
Punica Granatum Pleniflora Mouth Rinse
n=40 Participants
Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of "Golnaar" mouth rinse for 2 minutes every night for 2 weeks.
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses.
|
|---|---|---|
|
Modified Gingival Index
At base line
|
1.3 units on a scale
Standard Deviation 1
|
1.3 units on a scale
Standard Deviation 0.9
|
|
Modified Gingival Index
After 2 weeks
|
0.4 units on a scale
Standard Deviation 0.6
|
0.2 units on a scale
Standard Deviation 0.4
|
|
Modified Gingival Index
After 4 weeks
|
0.1 units on a scale
Standard Deviation 0.3
|
0 units on a scale
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: Up to 2 weeksOutcome measures
| Measure |
Chlorhexidine (0.2%)
n=36 Participants
Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (2%) for 2 minutes every night for 2 weeks.
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses.
|
Punica Granatum Pleniflora Mouth Rinse
n=38 Participants
Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of "Golnaar" mouth rinse for 2 minutes every night for 2 weeks.
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses.
|
|---|---|---|
|
Number of Participants With Adverse Events
No adverse event
|
15 participants
|
22 participants
|
|
Number of Participants With Adverse Events
Had some adverse event
|
21 participants
|
16 participants
|
SECONDARY outcome
Timeframe: Up to 2 weekWe use a Visual Analogue Scale (VAS) to evaluate the patients' satisfaction and their tolerance. This "VAS" ranged from 1 (not satisfied at all) to 5 (fully satisfied) was used: 1. Not satisfied at all 2. Not satisfied adequately 3. Not good-Not bad (So So) 4. Mostly Satisfied 5. Fully satisfied
Outcome measures
| Measure |
Chlorhexidine (0.2%)
n=36 Participants
Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (2%) for 2 minutes every night for 2 weeks.
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses.
|
Punica Granatum Pleniflora Mouth Rinse
n=38 Participants
Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of "Golnaar" mouth rinse for 2 minutes every night for 2 weeks.
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses.
|
|---|---|---|
|
Satisfaction of Patients
Satisfied
|
32 participants
|
36 participants
|
|
Satisfaction of Patients
Unsatisfied
|
1 participants
|
0 participants
|
|
Satisfaction of Patients
So-So
|
3 participants
|
2 participants
|
Adverse Events
Chlorhexidine (0.2%)
Punica Granatum Pleniflora Mouth Rinse
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Chlorhexidine (0.2%)
n=36 participants at risk
Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses.
|
Punica Granatum Pleniflora Mouth Rinse
n=38 participants at risk
Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.
Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of "Golnaar" mouth rinse for 2 minutes every night for 2 weeks.
Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses.
|
|---|---|---|
|
Surgical and medical procedures
Unpleasant taste
|
38.9%
14/36 • Number of events 14 • During the study and up to 1 month after finishing mouth rinses.
|
39.5%
15/38 • Number of events 15 • During the study and up to 1 month after finishing mouth rinses.
|
|
Surgical and medical procedures
Other side effects
|
11.1%
4/36 • Number of events 4 • During the study and up to 1 month after finishing mouth rinses.
|
0.00%
0/38 • During the study and up to 1 month after finishing mouth rinses.
|
|
Surgical and medical procedures
Discolored
|
8.3%
3/36 • Number of events 3 • During the study and up to 1 month after finishing mouth rinses.
|
0.00%
0/38 • During the study and up to 1 month after finishing mouth rinses.
|
|
Surgical and medical procedures
Bad Odor
|
0.00%
0/36 • During the study and up to 1 month after finishing mouth rinses.
|
2.6%
1/38 • Number of events 1 • During the study and up to 1 month after finishing mouth rinses.
|
Additional Information
Dr. Mahsa Rostami-Chijan
Shiraz University of Medical Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place