Trial Outcomes & Findings for Efficacy of Manual Toothbrushes in Removing Dental Plaque (NCT NCT04025684)
NCT ID: NCT04025684
Last Updated: 2021-01-28
Results Overview
Supra-gingival plaque was assessed on the facial and lingual surfaces of the teeth (7-7 each arch) using RPI. Each tooth surface was divided into 9 zones, for a total of 18 sites per tooth (A to I facial with 9 sites and lingual with 9 sites separately); A to C along gingival margin; D to F directly above A to C (D and F being inter-proximal zones); G to H across middle of tooth; and I covered incisal area. Plaque was disclosed and presence or absence of plaque in each zone was recorded as per scoring criteria: 0-Plaque absent, 1-Plaque present; where lower score represents better result. An average score for a participant was generated by averaging across all sites and surfaces of all teeth assessed. Change from pre-brushing = (post-brushing score - pre-brushing score). Overall mean calculated for all participants was reported.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
At Day 0
Results posted on
2021-01-28
Participant Flow
The study was conducted at single center in United Kingdom.
A total of 125 participants were screened, of whom 80 were randomized in 4 study product groups, 33 did not meet the study criteria, 2 were lost to follow-up, 2 withdrew consent, and 8 were not randomized due to other reason.
Participant milestones
| Measure |
Oral B Indicator 123
Participants randomized to this group dosed the Oral B Indicator 123 toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 milliliters (mL) tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Dr Best Original
Participants randomized to this group dosed the Dr Best Original toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Dr Best Multi Expert
Participants randomized to this group dosed the Dr Best Multi Expert toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Parodontax Interdental
Participants randomized to this group dosed the parodontax Interdental toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
19
|
20
|
21
|
|
Overall Study
COMPLETED
|
18
|
15
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
0
|
1
|
Reasons for withdrawal
| Measure |
Oral B Indicator 123
Participants randomized to this group dosed the Oral B Indicator 123 toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 milliliters (mL) tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Dr Best Original
Participants randomized to this group dosed the Dr Best Original toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Dr Best Multi Expert
Participants randomized to this group dosed the Dr Best Multi Expert toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Parodontax Interdental
Participants randomized to this group dosed the parodontax Interdental toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
|
Overall Study
Multiple reasons
|
1
|
3
|
0
|
1
|
Baseline Characteristics
Efficacy of Manual Toothbrushes in Removing Dental Plaque
Baseline characteristics by cohort
| Measure |
Oral B Indicator 123
n=20 Participants
Participants randomized to this group dosed the Oral B Indicator 123 toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Dr Best Original
n=19 Participants
Participants randomized to this group dosed the Dr Best Original toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Dr Best Multi Expert
n=20 Participants
Participants randomized to this group dosed the Dr Best Multi Expert toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Parodontax Interdental
n=21 Participants
Participants randomized to this group dosed the parodontax Interdental toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
79 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
52 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
62 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: At Day 0Population: Modified intent-to-treat population (mITT) comprised all randomized participants who had a postbaseline plaque assessment.
Supra-gingival plaque was assessed on the facial and lingual surfaces of the teeth (7-7 each arch) using RPI. Each tooth surface was divided into 9 zones, for a total of 18 sites per tooth (A to I facial with 9 sites and lingual with 9 sites separately); A to C along gingival margin; D to F directly above A to C (D and F being inter-proximal zones); G to H across middle of tooth; and I covered incisal area. Plaque was disclosed and presence or absence of plaque in each zone was recorded as per scoring criteria: 0-Plaque absent, 1-Plaque present; where lower score represents better result. An average score for a participant was generated by averaging across all sites and surfaces of all teeth assessed. Change from pre-brushing = (post-brushing score - pre-brushing score). Overall mean calculated for all participants was reported.
Outcome measures
| Measure |
Oral B Indicator 123
n=20 Participants
Participants randomized to this group dosed the Oral B Indicator 123 toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Dr Best Original
n=19 Participants
Participants randomized to this group dosed the Dr Best Original toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Dr Best Multi Expert
n=20 Participants
Participants randomized to this group dosed the Dr Best Multi Expert toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Parodontax Interdental
n=20 Participants
Participants randomized to this group dosed the parodontax Interdental toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
|---|---|---|---|---|
|
Change From Pre to Post Brushing in Overall Mean Rustogi Modified Navy Plaque Index (RPI) After a Single Brushing Event at Day 0
|
-0.09623 score on a scale
Standard Deviation 0.052741
|
-0.12005 score on a scale
Standard Deviation 0.055350
|
-0.09859 score on a scale
Standard Deviation 0.045509
|
-0.09599 score on a scale
Standard Deviation 0.044436
|
PRIMARY outcome
Timeframe: At Day 0Population: mITT comprised all randomized participants who had a postbaseline plaque assessment.
Supra-gingival plaque accumulation was assessed on facial and lingual surfaces of teeth (7-7 in each arch) using TPI. Plaque was assessed with each tooth being divided into 6 areas including mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces and scored for each site on a scale of 0 to 5: 0-No plaque, 1-Slight flecks of plaque at cervical margin of tooth, 2-Thin, continuous band of plaque (1millimetre \[mm\] or smaller) at cervical margin of tooth, 3-Band of plaque wider than 1mm but covering less than 1/3 of area, 4-Plaque covering at least 1/3 but less than 2/3 of area, 5-Plaque covering 2/3 or more of crown of tooth; where lower score represents better result. An average score for a participant was generated by averaging across all sites and surfaces of all teeth assessed. Change from pre-brushing = (post-brushing score - pre-brushing score). Overall mean calculated for all participants was reported.
Outcome measures
| Measure |
Oral B Indicator 123
n=20 Participants
Participants randomized to this group dosed the Oral B Indicator 123 toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Dr Best Original
n=19 Participants
Participants randomized to this group dosed the Dr Best Original toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Dr Best Multi Expert
n=20 Participants
Participants randomized to this group dosed the Dr Best Multi Expert toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Parodontax Interdental
n=20 Participants
Participants randomized to this group dosed the parodontax Interdental toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
|---|---|---|---|---|
|
Change From Pre to Post Brushing in Overall Mean Turesky Modified Quigley & Hein Plaque Index (TPI) After a Single Brushing Event at Day 0
|
-0.49354 Score on a scale
Standard Deviation 0.312963
|
-0.62218 Score on a scale
Standard Deviation 0.340491
|
-0.57721 Score on a scale
Standard Deviation 0.347314
|
-0.53714 Score on a scale
Standard Deviation 0.273720
|
SECONDARY outcome
Timeframe: At Day 0, Day 7 and Day 28Population: mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category.
Supra-gingival plaque was assessed on the facial and lingual surfaces of the teeth (7-7 each arch) using RPI. Each tooth surface was divided into 9 zones, for a total of 18 sites per tooth (A to I facial with 9 sites and lingual with 9 sites separately); A to C along gingival margin; D to F directly above A to C (D and F being inter-proximal zones); G to H across middle of tooth; and I covered incisal area. Plaque was disclosed and presence or absence of plaque in each zone was recorded as per scoring criteria: 0-Plaque absent, 1-Plaque present; where lower score represents better result. An average score for a participant was generated by averaging across all sites and surfaces of all teeth assessed. Change from Day 0 pre-brushing at Day 7/28 = (post-brushing score at Day 7/28- pre-brushing score at Day 0). Overall mean calculated for all participants was reported.
Outcome measures
| Measure |
Oral B Indicator 123
n=20 Participants
Participants randomized to this group dosed the Oral B Indicator 123 toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Dr Best Original
n=19 Participants
Participants randomized to this group dosed the Dr Best Original toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Dr Best Multi Expert
n=20 Participants
Participants randomized to this group dosed the Dr Best Multi Expert toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Parodontax Interdental
n=20 Participants
Participants randomized to this group dosed the parodontax Interdental toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
|---|---|---|---|---|
|
Change From Baseline (Day 0 Pre-Brushing) to Post-Brushing in Overall Mean Rustogi Modified Navy Plaque Index (RPI) at Day 7 and Day 28
Change at Day 7 Post brushing
|
-0.13485 score on a scale
Standard Deviation 0.057076
|
-0.16648 score on a scale
Standard Deviation 0.074227
|
-0.09813 score on a scale
Standard Deviation 0.068715
|
-0.11839 score on a scale
Standard Deviation 0.059674
|
|
Change From Baseline (Day 0 Pre-Brushing) to Post-Brushing in Overall Mean Rustogi Modified Navy Plaque Index (RPI) at Day 7 and Day 28
Change at Day 28 Post brushing
|
-0.14738 score on a scale
Standard Deviation 0.071082
|
-0.16234 score on a scale
Standard Deviation 0.047753
|
-0.12854 score on a scale
Standard Deviation 0.085085
|
-0.11835 score on a scale
Standard Deviation 0.070860
|
SECONDARY outcome
Timeframe: At Day 0, Day 7 and Day 28Population: mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category.
Supra-gingival plaque accumulation was assessed on facial and lingual surfaces of teeth (7-7 in each arch) using TPI. Plaque was assessed with each tooth being divided into 6 areas including mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces and scored for each site on a scale of 0 to 5: 0-No plaque, 1-Slight flecks of plaque at cervical margin of tooth, 2-Thin, continuous band of plaque (1mm or smaller) at cervical margin of tooth, 3-Band of plaque wider than 1mm but covering less than 1/3 of area, 4-Plaque covering at least 1/3 but less than 2/3 of area, 5-Plaque covering 2/3 or more of crown of tooth; where lower score represents better result. An average score for a participant was generated by averaging across all sites and surfaces of all teeth assessed. Change from Day 0 pre-brushing at Day 7/28 = (post-brushing score at Day 7/28- pre-brushing score at Day 0). Overall mean calculated for all participants was reported.
Outcome measures
| Measure |
Oral B Indicator 123
n=20 Participants
Participants randomized to this group dosed the Oral B Indicator 123 toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Dr Best Original
n=19 Participants
Participants randomized to this group dosed the Dr Best Original toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Dr Best Multi Expert
n=20 Participants
Participants randomized to this group dosed the Dr Best Multi Expert toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Parodontax Interdental
n=20 Participants
Participants randomized to this group dosed the parodontax Interdental toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
|---|---|---|---|---|
|
Change From Baseline (Day 0 Pre-Brushing) to Post-Brushing in Overall Mean Turesky Modified Quigley & Hein Plaque Index (TPI) at Day 7 and Day 28
Change at Day 28 Post brushing
|
-0.75755 score on a scale
Standard Deviation 0.330047
|
-0.79959 score on a scale
Standard Deviation 0.281520
|
-0.70769 score on a scale
Standard Deviation 0.438260
|
-0.60327 score on a scale
Standard Deviation 0.379847
|
|
Change From Baseline (Day 0 Pre-Brushing) to Post-Brushing in Overall Mean Turesky Modified Quigley & Hein Plaque Index (TPI) at Day 7 and Day 28
Change at Day 7 Post brushing
|
-0.71646 score on a scale
Standard Deviation 0.290669
|
-0.90569 score on a scale
Standard Deviation 0.436986
|
-0.63582 score on a scale
Standard Deviation 0.417132
|
-0.61935 score on a scale
Standard Deviation 0.348844
|
SECONDARY outcome
Timeframe: At Day 7 and Day 28Population: mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category.
Supra-gingival plaque was assessed on the facial and lingual surfaces of the teeth (7-7 each arch) using RPI. Each tooth surface was divided into 9 zones, for a total of 18 sites per tooth (A to I facial with 9 sites and lingual with 9 sites separately); A to C along gingival margin; D to F directly above A to C (D and F being inter-proximal zones); G to H across middle of tooth; and I covered incisal area. Plaque was disclosed and presence or absence of plaque in each zone was recorded as per scoring criteria: 0-Plaque absent, 1-Plaque present; where lower score represents better result. An average score for a participant was generated by averaging across all sites and surfaces of all teeth assessed. Overall mean calculated for all participants was reported.
Outcome measures
| Measure |
Oral B Indicator 123
n=20 Participants
Participants randomized to this group dosed the Oral B Indicator 123 toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Dr Best Original
n=19 Participants
Participants randomized to this group dosed the Dr Best Original toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Dr Best Multi Expert
n=20 Participants
Participants randomized to this group dosed the Dr Best Multi Expert toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Parodontax Interdental
n=20 Participants
Participants randomized to this group dosed the parodontax Interdental toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
|---|---|---|---|---|
|
Overall Mean Rustogi Modified Navy Plaque Index (RPI) Pre- and Post-brushing at Day 7 and Day 28
At Day 7 Pre-brushing
|
0.443 score on a scale
Standard Deviation 0.0739
|
0.438 score on a scale
Standard Deviation 0.0859
|
0.468 score on a scale
Standard Deviation 0.0738
|
0.449 score on a scale
Standard Deviation 0.0654
|
|
Overall Mean Rustogi Modified Navy Plaque Index (RPI) Pre- and Post-brushing at Day 7 and Day 28
At Day 28 Pre-brushing
|
0.443 score on a scale
Standard Deviation 0.0920
|
0.467 score on a scale
Standard Deviation 0.0888
|
0.467 score on a scale
Standard Deviation 0.0721
|
0.434 score on a scale
Standard Deviation 0.0756
|
|
Overall Mean Rustogi Modified Navy Plaque Index (RPI) Pre- and Post-brushing at Day 7 and Day 28
At Day 7 Post-brushing
|
0.352 score on a scale
Standard Deviation 0.0695
|
0.333 score on a scale
Standard Deviation 0.0749
|
0.390 score on a scale
Standard Deviation 0.0924
|
0.352 score on a scale
Standard Deviation 0.0681
|
|
Overall Mean Rustogi Modified Navy Plaque Index (RPI) Pre- and Post-brushing at Day 7 and Day 28
At Day 28 Post-brushing
|
0.340 score on a scale
Standard Deviation 0.1113
|
0.343 score on a scale
Standard Deviation 0.0974
|
0.360 score on a scale
Standard Deviation 0.0802
|
0.352 score on a scale
Standard Deviation 0.0736
|
SECONDARY outcome
Timeframe: At Day 7 and Day 28Population: mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category.
Supra-gingival plaque accumulation was assessed on facial and lingual surfaces of teeth (7-7 in each arch) using TPI. Plaque was assessed with each tooth being divided into 6 areas including mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces and scored for each site on a scale of 0 to 5: 0-No plaque, 1-Slight flecks of plaque at cervical margin of tooth, 2-Thin, continuous band of plaque (1mm or smaller) at cervical margin of tooth, 3-Band of plaque wider than 1mm but covering less than 1/3 of area, 4-Plaque covering at least 1/3 but less than 2/3 of area, 5-Plaque covering 2/3 or more of crown of tooth; where lower score represents better result. An average score for a participant was generated by averaging across all sites and surfaces of all teeth assessed. Overall mean calculated for all participants was reported.
Outcome measures
| Measure |
Oral B Indicator 123
n=20 Participants
Participants randomized to this group dosed the Oral B Indicator 123 toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Dr Best Original
n=19 Participants
Participants randomized to this group dosed the Dr Best Original toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Dr Best Multi Expert
n=20 Participants
Participants randomized to this group dosed the Dr Best Multi Expert toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Parodontax Interdental
n=20 Participants
Participants randomized to this group dosed the parodontax Interdental toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
|---|---|---|---|---|
|
Overall Mean Turesky Modified Quigley & Hein Plaque Index (TPI) Pre- and Post-brushing TPI at Day 7, and Day 28
At Day 28 Post-brushing
|
1.766 score on a scale
Standard Deviation 0.5549
|
1.788 score on a scale
Standard Deviation 0.5161
|
1.870 score on a scale
Standard Deviation 0.4209
|
1.832 score on a scale
Standard Deviation 0.4330
|
|
Overall Mean Turesky Modified Quigley & Hein Plaque Index (TPI) Pre- and Post-brushing TPI at Day 7, and Day 28
At Day 7 Pre-brushing
|
2.361 score on a scale
Standard Deviation 0.4198
|
2.368 score on a scale
Standard Deviation 0.5218
|
2.508 score on a scale
Standard Deviation 0.4270
|
2.446 score on a scale
Standard Deviation 0.3834
|
|
Overall Mean Turesky Modified Quigley & Hein Plaque Index (TPI) Pre- and Post-brushing TPI at Day 7, and Day 28
At Day 7 Post-brushing
|
1.803 score on a scale
Standard Deviation 0.4084
|
1.669 score on a scale
Standard Deviation 0.4246
|
1.945 score on a scale
Standard Deviation 0.5175
|
1.816 score on a scale
Standard Deviation 0.3902
|
|
Overall Mean Turesky Modified Quigley & Hein Plaque Index (TPI) Pre- and Post-brushing TPI at Day 7, and Day 28
At Day 28 Pre-brushing
|
2.327 score on a scale
Standard Deviation 0.5263
|
2.459 score on a scale
Standard Deviation 0.4062
|
2.452 score on a scale
Standard Deviation 0.2773
|
2.346 score on a scale
Standard Deviation 0.3421
|
SECONDARY outcome
Timeframe: At Day 0, Day 7 and Day 28Population: mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category.
Supra-gingival plaque accumulation was assessed for gingival zone A to C. Plaque was disclosed and presence or absence of plaque in each zone was recorded as per scoring criteria: 0-Plaque absent, 1-Plaque present; where lower score represents better result. An average score for a participant was generated by averaging across all sites and surfaces of all teeth assessed. Change from Day 0 pre-brushing at Day 0/7/28= (post-brushing score at Day 0/7/28- pre-brushing score at Day 0). Mean calculated for all participants was reported.
Outcome measures
| Measure |
Oral B Indicator 123
n=20 Participants
Participants randomized to this group dosed the Oral B Indicator 123 toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Dr Best Original
n=19 Participants
Participants randomized to this group dosed the Dr Best Original toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Dr Best Multi Expert
n=20 Participants
Participants randomized to this group dosed the Dr Best Multi Expert toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Parodontax Interdental
n=20 Participants
Participants randomized to this group dosed the parodontax Interdental toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
|---|---|---|---|---|
|
Change From Baseline (Day 0 Pre-Brushing) to Post-Brushing in Gingival Margin Sites Mean Rustogi Modified Navy Plaque Index (RPI) at Day 0, Day 7 and Day 28
Change at Day 0 Post brushing
|
-0.04938 score on a scale
Standard Deviation 0.054115
|
-0.09034 score on a scale
Standard Deviation 0.092453
|
-0.05344 score on a scale
Standard Deviation 0.059657
|
-0.07211 score on a scale
Standard Deviation 0.058880
|
|
Change From Baseline (Day 0 Pre-Brushing) to Post-Brushing in Gingival Margin Sites Mean Rustogi Modified Navy Plaque Index (RPI) at Day 0, Day 7 and Day 28
Change at Day 7 Post brushing
|
-0.12498 score on a scale
Standard Deviation 0.096075
|
-0.16961 score on a scale
Standard Deviation 0.132531
|
-0.09456 score on a scale
Standard Deviation 0.095039
|
-0.12165 score on a scale
Standard Deviation 0.089975
|
|
Change From Baseline (Day 0 Pre-Brushing) to Post-Brushing in Gingival Margin Sites Mean Rustogi Modified Navy Plaque Index (RPI) at Day 0, Day 7 and Day 28
Change at Day 28 Post brushing
|
-0.17348 score on a scale
Standard Deviation 0.152077
|
-0.16314 score on a scale
Standard Deviation 0.156324
|
-0.12075 score on a scale
Standard Deviation 0.123455
|
-0.10500 score on a scale
Standard Deviation 0.110297
|
SECONDARY outcome
Timeframe: At Day 0, Day 7 and Day 28Population: mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category.
Supra-gingival plaque accumulation was assessed for inter-proximal zones D to F. Plaque was disclosed and presence or absence of plaque in each zone was recorded as per scoring criteria: 0-Plaque absent, 1-Plaque present; where lower score represents better result. An average score for a participant was generated by averaging across all sites and surfaces of all teeth assessed. Change from Day 0 pre-brushing at Day 0/7/28= (post-brushing score at Day 0/7/28- pre-brushing score at Day 0). Mean calculated for all participants was reported.
Outcome measures
| Measure |
Oral B Indicator 123
n=20 Participants
Participants randomized to this group dosed the Oral B Indicator 123 toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Dr Best Original
n=19 Participants
Participants randomized to this group dosed the Dr Best Original toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Dr Best Multi Expert
n=20 Participants
Participants randomized to this group dosed the Dr Best Multi Expert toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Parodontax Interdental
n=20 Participants
Participants randomized to this group dosed the parodontax Interdental toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
|---|---|---|---|---|
|
Change From Baseline (Day 0 Pre-Brushing) to Post-Brushing in Inter-Proximal Sites Mean Rustogi Modified Navy Plaque Index (RPI) at Day 0, Day 7 and Day 28
Change at Day 0 Post brushing
|
-0.26809 score on a scale
Standard Deviation 0.130993
|
-0.28219 score on a scale
Standard Deviation 0.133379
|
-0.25775 score on a scale
Standard Deviation 0.123545
|
-0.22865 score on a scale
Standard Deviation 0.130830
|
|
Change From Baseline (Day 0 Pre-Brushing) to Post-Brushing in Inter-Proximal Sites Mean Rustogi Modified Navy Plaque Index (RPI) at Day 0, Day 7 and Day 28
Change at Day 7 Post brushing
|
-0.31485 score on a scale
Standard Deviation 0.161214
|
-0.33171 score on a scale
Standard Deviation 0.188937
|
-0.21269 score on a scale
Standard Deviation 0.167972
|
-0.24499 score on a scale
Standard Deviation 0.172251
|
|
Change From Baseline (Day 0 Pre-Brushing) to Post-Brushing in Inter-Proximal Sites Mean Rustogi Modified Navy Plaque Index (RPI) at Day 0, Day 7 and Day 28
Change at Day 28 Post brushing
|
-0.30399 score on a scale
Standard Deviation 0.153080
|
-0.32138 score on a scale
Standard Deviation 0.130552
|
-0.26825 score on a scale
Standard Deviation 0.188777
|
-0.25411 score on a scale
Standard Deviation 0.191171
|
SECONDARY outcome
Timeframe: At Day 0, Day 7 and Day 28Population: mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category.
Supra-gingival plaque accumulation was assessed for inter-proximal zones D to F. Plaque was disclosed and scored for each site on a scale of 0 to 5: 0-No plaque, 1-Slight flecks of plaque at cervical margin of tooth, 2-Thin, continuous band of plaque (1mm or smaller) at cervical margin of tooth, 3-Band of plaque wider than 1mm but covering less than 1/3 of area, 4-Plaque covering at least 1/3 but less than 2/3 of area, 5-Plaque covering 2/3 or more of crown of tooth; where lower score represents better result. An average score for a participant was generated by averaging across all sites and surfaces of all teeth assessed. Change from Day 0 pre-brushing at Day 0/7/28= (post-brushing score at Day 0/7/28- pre-brushing score at Day 0). Mean calculated for all participants was reported.
Outcome measures
| Measure |
Oral B Indicator 123
n=20 Participants
Participants randomized to this group dosed the Oral B Indicator 123 toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Dr Best Original
n=19 Participants
Participants randomized to this group dosed the Dr Best Original toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Dr Best Multi Expert
n=20 Participants
Participants randomized to this group dosed the Dr Best Multi Expert toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Parodontax Interdental
n=20 Participants
Participants randomized to this group dosed the parodontax Interdental toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
|---|---|---|---|---|
|
Change From Baseline (Day 0 Pre-Brushing) to Post-Brushing in Inter-Proximal Sites Mean Turesky Modified Quigley & Hein Plaque Index (TPI) at Day 0, Day 7 and Day 28
Change at Day 0 Post brushing
|
-0.49949 score on a scale
Standard Deviation 0.314629
|
-0.60975 score on a scale
Standard Deviation 0.337375
|
-0.58666 score on a scale
Standard Deviation 0.352225
|
-0.49861 score on a scale
Standard Deviation 0.291868
|
|
Change From Baseline (Day 0 Pre-Brushing) to Post-Brushing in Inter-Proximal Sites Mean Turesky Modified Quigley & Hein Plaque Index (TPI) at Day 0, Day 7 and Day 28
Change at Day 7 Post brushing
|
-0.72054 score on a scale
Standard Deviation 0.293855
|
-0.89035 score on a scale
Standard Deviation 0.429582
|
-0.62843 score on a scale
Standard Deviation 0.400444
|
-0.56209 score on a scale
Standard Deviation 0.365074
|
|
Change From Baseline (Day 0 Pre-Brushing) to Post-Brushing in Inter-Proximal Sites Mean Turesky Modified Quigley & Hein Plaque Index (TPI) at Day 0, Day 7 and Day 28
Change at Day 28 Post brushing
|
-0.78797 score on a scale
Standard Deviation 0.326878
|
-0.81581 score on a scale
Standard Deviation 0.261399
|
-0.72924 score on a scale
Standard Deviation 0.445553
|
-0.58135 score on a scale
Standard Deviation 0.389490
|
SECONDARY outcome
Timeframe: At Day 0, Day 7 and Day 28Population: mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category.
Supra-gingival plaque accumulation was assessed for gingival zone A to C. Plaque was disclosed and presence or absence of plaque in each zone was recorded as per scoring criteria: 0-Plaque absent, 1-Plaque present; where lower score represents better result. An average score for a participant was generated by averaging across all sites and surfaces of all teeth assessed. Mean calculated for all participants was reported.
Outcome measures
| Measure |
Oral B Indicator 123
n=20 Participants
Participants randomized to this group dosed the Oral B Indicator 123 toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Dr Best Original
n=19 Participants
Participants randomized to this group dosed the Dr Best Original toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Dr Best Multi Expert
n=20 Participants
Participants randomized to this group dosed the Dr Best Multi Expert toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Parodontax Interdental
n=20 Participants
Participants randomized to this group dosed the parodontax Interdental toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
|---|---|---|---|---|
|
Gingival Margin Sites Mean Rustogi Modified Navy Plaque Index (RPI) Pre- and Post-brushing at Day 0, Day 7 and Day 28
At Day 0 Post-brushing
|
0.939 score on a scale
Standard Deviation 0.0635
|
0.896 score on a scale
Standard Deviation 0.0932
|
0.939 score on a scale
Standard Deviation 0.0577
|
0.909 score on a scale
Standard Deviation 0.0894
|
|
Gingival Margin Sites Mean Rustogi Modified Navy Plaque Index (RPI) Pre- and Post-brushing at Day 0, Day 7 and Day 28
At Day 7 Post-brushing
|
0.863 score on a scale
Standard Deviation 0.1046
|
0.818 score on a scale
Standard Deviation 0.1429
|
0.898 score on a scale
Standard Deviation 0.0931
|
0.859 score on a scale
Standard Deviation 0.1056
|
|
Gingival Margin Sites Mean Rustogi Modified Navy Plaque Index (RPI) Pre- and Post-brushing at Day 0, Day 7 and Day 28
At Day 0 Pre-brushing
|
0.988 score on a scale
Standard Deviation 0.0227
|
0.987 score on a scale
Standard Deviation 0.0213
|
0.992 score on a scale
Standard Deviation 0.0115
|
0.981 score on a scale
Standard Deviation 0.0481
|
|
Gingival Margin Sites Mean Rustogi Modified Navy Plaque Index (RPI) Pre- and Post-brushing at Day 0, Day 7 and Day 28
At Day 7 Pre-brushing
|
0.966 score on a scale
Standard Deviation 0.0488
|
0.952 score on a scale
Standard Deviation 0.0831
|
0.978 score on a scale
Standard Deviation 0.0376
|
0.969 score on a scale
Standard Deviation 0.0406
|
|
Gingival Margin Sites Mean Rustogi Modified Navy Plaque Index (RPI) Pre- and Post-brushing at Day 0, Day 7 and Day 28
At Day 28 Pre-brushing
|
0.945 score on a scale
Standard Deviation 0.1094
|
0.974 score on a scale
Standard Deviation 0.0436
|
0.983 score on a scale
Standard Deviation 0.0252
|
0.964 score on a scale
Standard Deviation 0.0657
|
|
Gingival Margin Sites Mean Rustogi Modified Navy Plaque Index (RPI) Pre- and Post-brushing at Day 0, Day 7 and Day 28
At Day 28 Post-brushing
|
0.814 score on a scale
Standard Deviation 0.1625
|
0.825 score on a scale
Standard Deviation 0.1686
|
0.871 score on a scale
Standard Deviation 0.1218
|
0.876 score on a scale
Standard Deviation 0.1127
|
SECONDARY outcome
Timeframe: At Day 0, Day 7 and Day 28Population: mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category.
Supra-gingival plaque accumulation was assessed for inter-proximal zones D to F. Plaque was disclosed and presence or absence of plaque in each zone was recorded as per scoring criteria: 0-Plaque absent, 1-Plaque present; where lower score represents better result. An average score for a participant was generated by averaging across all sites and surfaces of all teeth assessed. Mean calculated for all participants was reported.
Outcome measures
| Measure |
Oral B Indicator 123
n=20 Participants
Participants randomized to this group dosed the Oral B Indicator 123 toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Dr Best Original
n=19 Participants
Participants randomized to this group dosed the Dr Best Original toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Dr Best Multi Expert
n=20 Participants
Participants randomized to this group dosed the Dr Best Multi Expert toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Parodontax Interdental
n=20 Participants
Participants randomized to this group dosed the parodontax Interdental toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
|---|---|---|---|---|
|
Inter-Proximal Sites Mean Rustogi Modified Navy Plaque Index (RPI) Pre- and Post-brushing at Day 0, Day 7 and Day 28
At Day 0 Pre-brushing
|
0.523 score on a scale
Standard Deviation 0.2121
|
0.499 score on a scale
Standard Deviation 0.2217
|
0.507 score on a scale
Standard Deviation 0.1626
|
0.467 score on a scale
Standard Deviation 0.1910
|
|
Inter-Proximal Sites Mean Rustogi Modified Navy Plaque Index (RPI) Pre- and Post-brushing at Day 0, Day 7 and Day 28
At Day 0 Post-brushing
|
0.255 score on a scale
Standard Deviation 0.1551
|
0.217 score on a scale
Standard Deviation 0.1611
|
0.249 score on a scale
Standard Deviation 0.1422
|
0.238 score on a scale
Standard Deviation 0.1397
|
|
Inter-Proximal Sites Mean Rustogi Modified Navy Plaque Index (RPI) Pre- and Post-brushing at Day 0, Day 7 and Day 28
At Day 7 Pre-brushing
|
0.389 score on a scale
Standard Deviation 0.2041
|
0.371 score on a scale
Standard Deviation 0.2083
|
0.453 score on a scale
Standard Deviation 0.1969
|
0.408 score on a scale
Standard Deviation 0.1668
|
|
Inter-Proximal Sites Mean Rustogi Modified Navy Plaque Index (RPI) Pre- and Post-brushing at Day 0, Day 7 and Day 28
At Day 7 Post-brushing
|
0.214 score on a scale
Standard Deviation 0.1344
|
0.191 score on a scale
Standard Deviation 0.1080
|
0.294 score on a scale
Standard Deviation 0.2048
|
0.222 score on a scale
Standard Deviation 0.1187
|
|
Inter-Proximal Sites Mean Rustogi Modified Navy Plaque Index (RPI) Pre- and Post-brushing at Day 0, Day 7 and Day 28
At Day 28 Pre-brushing
|
0.431 score on a scale
Standard Deviation 0.2299
|
0.442 score on a scale
Standard Deviation 0.2341
|
0.479 score on a scale
Standard Deviation 0.2370
|
0.381 score on a scale
Standard Deviation 0.2083
|
|
Inter-Proximal Sites Mean Rustogi Modified Navy Plaque Index (RPI) Pre- and Post-brushing at Day 0, Day 7 and Day 28
At Day 28 Post-brushing
|
0.227 score on a scale
Standard Deviation 0.2136
|
0.217 score on a scale
Standard Deviation 0.1478
|
0.239 score on a scale
Standard Deviation 0.1666
|
0.213 score on a scale
Standard Deviation 0.1640
|
SECONDARY outcome
Timeframe: At Day 0, Day 7 and Day 28Population: mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category.
Supra-gingival plaque accumulation was assessed for inter-proximal zones D to F. Plaque was disclosed and scored for each site on a scale of 0 to 5: 0-No plaque, 1-Slight flecks of plaque at cervical margin of tooth, 2-Thin, continuous band of plaque (1mm or smaller) at cervical margin of tooth, 3-Band of plaque wider than 1mm but covering less than 1/3 of area, 4-Plaque covering at least 1/3 but less than 2/3 of area, 5-Plaque covering 2/3 or more of crown of tooth; where lower score represents better result. An average score for a participant was generated by averaging across all sites and surfaces of all teeth assessed. Mean calculated for all participants was reported.
Outcome measures
| Measure |
Oral B Indicator 123
n=20 Participants
Participants randomized to this group dosed the Oral B Indicator 123 toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Dr Best Original
n=19 Participants
Participants randomized to this group dosed the Dr Best Original toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Dr Best Multi Expert
n=20 Participants
Participants randomized to this group dosed the Dr Best Multi Expert toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Parodontax Interdental
n=20 Participants
Participants randomized to this group dosed the parodontax Interdental toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
|---|---|---|---|---|
|
Inter-Proximal Sites Mean Turesky Modified Quigley & Hein Plaque Index (TPI) Pre- and Post-brushing TPI at Day 0, Day 7 and Day 28
At Day 7 Post-brushing
|
1.937 score on a scale
Standard Deviation 0.4208
|
1.821 score on a scale
Standard Deviation 0.4075
|
2.109 score on a scale
Standard Deviation 0.5191
|
1.991 score on a scale
Standard Deviation 0.3755
|
|
Inter-Proximal Sites Mean Turesky Modified Quigley & Hein Plaque Index (TPI) Pre- and Post-brushing TPI at Day 0, Day 7 and Day 28
At Day 0 Pre-brushing
|
2.643 score on a scale
Standard Deviation 0.3965
|
2.649 score on a scale
Standard Deviation 0.4338
|
2.737 score on a scale
Standard Deviation 0.3425
|
2.552 score on a scale
Standard Deviation 0.4292
|
|
Inter-Proximal Sites Mean Turesky Modified Quigley & Hein Plaque Index (TPI) Pre- and Post-brushing TPI at Day 0, Day 7 and Day 28
At Day 0 Post-brushing
|
2.141 score on a scale
Standard Deviation 0.3735
|
2.041 score on a scale
Standard Deviation 0.3815
|
2.149 score on a scale
Standard Deviation 0.2642
|
2.054 score on a scale
Standard Deviation 0.4217
|
|
Inter-Proximal Sites Mean Turesky Modified Quigley & Hein Plaque Index (TPI) Pre- and Post-brushing TPI at Day 0, Day 7 and Day 28
At Day 7 Pre-brushing
|
2.481 score on a scale
Standard Deviation 0.4396
|
2.493 score on a scale
Standard Deviation 0.4949
|
2.635 score on a scale
Standard Deviation 0.4564
|
2.577 score on a scale
Standard Deviation 0.4149
|
|
Inter-Proximal Sites Mean Turesky Modified Quigley & Hein Plaque Index (TPI) Pre- and Post-brushing TPI at Day 0, Day 7 and Day 28
At Day 28 Pre-brushing
|
2.410 score on a scale
Standard Deviation 0.5228
|
2.550 score on a scale
Standard Deviation 0.3968
|
2.561 score on a scale
Standard Deviation 0.2938
|
2.454 score on a scale
Standard Deviation 0.3358
|
|
Inter-Proximal Sites Mean Turesky Modified Quigley & Hein Plaque Index (TPI) Pre- and Post-brushing TPI at Day 0, Day 7 and Day 28
At Day 28 Post-brushing
|
1.871 score on a scale
Standard Deviation 0.5645
|
1.911 score on a scale
Standard Deviation 0.4994
|
2.007 score on a scale
Standard Deviation 0.4122
|
1.972 score on a scale
Standard Deviation 0.4141
|
SECONDARY outcome
Timeframe: At Day 0, Day 7 pre-brushing and Day 28 pre-brushingPopulation: mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category.
Supra-gingival plaque was assessed on the facial and lingual surfaces of the teeth (7-7 each arch) using RPI. Each tooth surface was divided into 9 zones, for a total of 18 sites per tooth (A to I facial with 9 sites and lingual with 9 sites separately); A to C along gingival margin; D to F directly above A to C (D and F being inter-proximal zones); G to H across middle of tooth; and I covered incisal area. Plaque was disclosed and presence or absence of plaque in each zone was recorded as per scoring criteria: 0-Plaque absent, 1-Plaque present; where lower score represents better result. An average score for a participant was generated by averaging across all sites and surfaces of all teeth assessed. Change from Day 0 pre-brushing at Day 7/28= (pre-brushing score at Day 7/28- pre-brushing score at Day 0). Overall mean calculated for all participants was reported.
Outcome measures
| Measure |
Oral B Indicator 123
n=20 Participants
Participants randomized to this group dosed the Oral B Indicator 123 toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Dr Best Original
n=19 Participants
Participants randomized to this group dosed the Dr Best Original toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Dr Best Multi Expert
n=20 Participants
Participants randomized to this group dosed the Dr Best Multi Expert toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Parodontax Interdental
n=20 Participants
Participants randomized to this group dosed the parodontax Interdental toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
|---|---|---|---|---|
|
Change From Baseline (Day 0 Pre-Brushing) in Overall Rustogi Modified Navy Plaque Index (RPI) at Day 7 Pre-brushing and Day 28 Pre-brushing
At Day 7 Pre-brushing
|
-0.04465 score on a scale
Standard Deviation 0.060772
|
-0.06178 score on a scale
Standard Deviation 0.058426
|
-0.01992 score on a scale
Standard Deviation 0.050254
|
-0.02163 score on a scale
Standard Deviation 0.056758
|
|
Change From Baseline (Day 0 Pre-Brushing) in Overall Rustogi Modified Navy Plaque Index (RPI) at Day 7 Pre-brushing and Day 28 Pre-brushing
At Day 28 Pre-brushing
|
-0.04420 score on a scale
Standard Deviation 0.060384
|
-0.03796 score on a scale
Standard Deviation 0.060434
|
-0.02121 score on a scale
Standard Deviation 0.061780
|
-0.03689 score on a scale
Standard Deviation 0.075670
|
SECONDARY outcome
Timeframe: At Day 0, Day 7 pre-brushing and Day 28 pre-brushingPopulation: mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category.
Supra-gingival plaque accumulation was assessed on facial and lingual surfaces of teeth (7-7 in each arch) using TPI. Plaque was assessed with each tooth being divided into 6 areas including mesiofacial, facial, distofacial, mesiolingual, lingual and distolingual surfaces and scored for each site on a scale of 0 to 5: 0-No plaque, 1-Slight flecks of plaque at cervical margin of tooth, 2-Thin, continuous band of plaque (1mm or smaller) at cervical margin of tooth, 3-Band of plaque wider than 1mm but covering less than 1/3 of area, 4-Plaque covering at least 1/3 but less than 2/3 of area, 5-Plaque covering 2/3 or more of crown of tooth; where lower score represents better result. An average score for a participant was generated by averaging across all sites and surfaces of all teeth assessed. Change from Day 0 pre-brushing at Day 7/28= (pre-brushing score at Day 7/28- pre-brushing score at Day 0). Overall mean calculated for all participants was reported.
Outcome measures
| Measure |
Oral B Indicator 123
n=20 Participants
Participants randomized to this group dosed the Oral B Indicator 123 toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Dr Best Original
n=19 Participants
Participants randomized to this group dosed the Dr Best Original toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Dr Best Multi Expert
n=20 Participants
Participants randomized to this group dosed the Dr Best Multi Expert toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Parodontax Interdental
n=20 Participants
Participants randomized to this group dosed the parodontax Interdental toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
|---|---|---|---|---|
|
Change From Baseline (Day 0 Pre-Brushing) in Overall Mean Turesky Modified Quigley & Hein Plaque Index (TPI) at Day 7 Pre-brushing and Day 28 Pre-brushing
At Day 7 pre-brushing
|
-0.15663 score on a scale
Standard Deviation 0.307019
|
-0.20746 score on a scale
Standard Deviation 0.360506
|
-0.07029 score on a scale
Standard Deviation 0.315099
|
0.01187 score on a scale
Standard Deviation 0.282108
|
|
Change From Baseline (Day 0 Pre-Brushing) in Overall Mean Turesky Modified Quigley & Hein Plaque Index (TPI) at Day 7 Pre-brushing and Day 28 Pre-brushing
At Day 28 pre-brushing
|
-0.19667 score on a scale
Standard Deviation 0.343446
|
-0.12896 score on a scale
Standard Deviation 0.236209
|
-0.12756 score on a scale
Standard Deviation 0.302698
|
-0.08991 score on a scale
Standard Deviation 0.357293
|
SECONDARY outcome
Timeframe: At Day 0, Day 7 pre-brushing and Day 28 pre-brushingPopulation: mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category.
Supra-gingival plaque accumulation was assessed for gingival zone A to C. Plaque was disclosed and presence or absence of plaque in each zone was recorded as per scoring criteria: 0-Plaque absent, 1-Plaque present; where lower score represents better result. An average score for a participant was generated by averaging across all sites and surfaces of all teeth assessed. Change from Day 0 pre-brushing at Day 7/28= (pre-brushing score at Day 7/28- pre-brushing score at Day 0). Mean calculated for all participants was reported.
Outcome measures
| Measure |
Oral B Indicator 123
n=20 Participants
Participants randomized to this group dosed the Oral B Indicator 123 toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Dr Best Original
n=19 Participants
Participants randomized to this group dosed the Dr Best Original toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Dr Best Multi Expert
n=20 Participants
Participants randomized to this group dosed the Dr Best Multi Expert toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Parodontax Interdental
n=20 Participants
Participants randomized to this group dosed the parodontax Interdental toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
|---|---|---|---|---|
|
Change From Baseline (Day 0 Pre-Brushing) in Gingival Margin Sites Mean Rustogi Modified Navy Plaque Index (RPI) at Day 7 Pre-brushing and Day 28 Pre-brushing
At Day 7 pre-brushing
|
-0.02233 score on a scale
Standard Deviation 0.035312
|
-0.03645 score on a scale
Standard Deviation 0.066621
|
-0.01378 score on a scale
Standard Deviation 0.040284
|
-0.01219 score on a scale
Standard Deviation 0.038447
|
|
Change From Baseline (Day 0 Pre-Brushing) in Gingival Margin Sites Mean Rustogi Modified Navy Plaque Index (RPI) at Day 7 Pre-brushing and Day 28 Pre-brushing
At Day 28 pre-brushing
|
-0.04272 score on a scale
Standard Deviation 0.100638
|
-0.01355 score on a scale
Standard Deviation 0.034877
|
-0.00943 score on a scale
Standard Deviation 0.026501
|
-0.01715 score on a scale
Standard Deviation 0.083641
|
SECONDARY outcome
Timeframe: At Day 0, Day 7 pre-brushing and Day 28 pre-brushingPopulation: mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category.
Supra-gingival plaque accumulation was assessed for inter-proximal zones D to F. Plaque was disclosed and presence or absence of plaque in each zone was recorded as per scoring criteria: 0-Plaque absent, 1-Plaque present; where lower score represents better result. An average score for a participant was generated by averaging across all sites and surfaces of all teeth assessed. Change from Day 0 pre-brushing at Day 7/28= (pre-brushing score at Day 7/28- pre-brushing score at Day 0). Mean calculated for all participants was reported.
Outcome measures
| Measure |
Oral B Indicator 123
n=20 Participants
Participants randomized to this group dosed the Oral B Indicator 123 toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Dr Best Original
n=19 Participants
Participants randomized to this group dosed the Dr Best Original toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Dr Best Multi Expert
n=20 Participants
Participants randomized to this group dosed the Dr Best Multi Expert toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Parodontax Interdental
n=20 Participants
Participants randomized to this group dosed the parodontax Interdental toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
|---|---|---|---|---|
|
Change From Baseline (Day 0 Pre-Brushing) in Inter-Proximal Sites Mean Rustogi Modified Navy Plaque Index (RPI) at Day 7 Pre-brushing and Day 28 Pre-brushing
At Day 28 pre-brushing
|
-0.09970 score on a scale
Standard Deviation 0.132324
|
-0.09659 score on a scale
Standard Deviation 0.197697
|
-0.02755 score on a scale
Standard Deviation 0.204586
|
-0.08592 score on a scale
Standard Deviation 0.215974
|
|
Change From Baseline (Day 0 Pre-Brushing) in Inter-Proximal Sites Mean Rustogi Modified Navy Plaque Index (RPI) at Day 7 Pre-brushing and Day 28 Pre-brushing
At Day 7 pre-brushing
|
-0.13944 score on a scale
Standard Deviation 0.184635
|
-0.15199 score on a scale
Standard Deviation 0.162624
|
-0.05413 score on a scale
Standard Deviation 0.144292
|
-0.05919 score on a scale
Standard Deviation 0.175623
|
SECONDARY outcome
Timeframe: At Day 0, Day 7 pre-brushing and Day 28 pre-brushingPopulation: mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category.
Supra-gingival plaque accumulation was assessed for inter-proximal zones D to F. Plaque was disclosed and scored for each site on a scale of 0 to 5: 0-No plaque, 1-Slight flecks of plaque at cervical margin of tooth, 2-Thin, continuous band of plaque (1mm or smaller) at cervical margin of tooth, 3-Band of plaque wider than 1mm but covering less than 1/3 of area, 4-Plaque covering at least 1/3 but less than 2/3 of area, 5-Plaque covering 2/3 or more of crown of tooth; where lower score represents better result. An average score for a participant was generated by averaging across all sites and surfaces of all teeth assessed. Change from Day 0 pre-brushing at Day 7/28= (pre-brushing score at Day 7/28- pre-brushing score at Day 0). Mean calculated for all participants was reported.
Outcome measures
| Measure |
Oral B Indicator 123
n=20 Participants
Participants randomized to this group dosed the Oral B Indicator 123 toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Dr Best Original
n=19 Participants
Participants randomized to this group dosed the Dr Best Original toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Dr Best Multi Expert
n=20 Participants
Participants randomized to this group dosed the Dr Best Multi Expert toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Parodontax Interdental
n=20 Participants
Participants randomized to this group dosed the parodontax Interdental toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
|---|---|---|---|---|
|
Change From Baseline (Day 0 Pre-Brushing) in Inter-Proximal Sites Mean Turesky Modified Quigley & Hein Plaque Index (TPI) at Day 7 Pre-brushing and Day 28 Pre-brushing
At Day 7 pre-brushing
|
-0.17652 Score on a scale
Standard Deviation 0.309335
|
-0.21666 Score on a scale
Standard Deviation 0.366396
|
-0.10226 Score on a scale
Standard Deviation 0.315550
|
0.02326 Score on a scale
Standard Deviation 0.316914
|
|
Change From Baseline (Day 0 Pre-Brushing) in Inter-Proximal Sites Mean Turesky Modified Quigley & Hein Plaque Index (TPI) at Day 7 Pre-brushing and Day 28 Pre-brushing
At Day 28 pre-brushing
|
-0.25042 Score on a scale
Standard Deviation 0.332584
|
-0.17761 Score on a scale
Standard Deviation 0.225399
|
-0.17561 Score on a scale
Standard Deviation 0.327045
|
-0.09889 Score on a scale
Standard Deviation 0.370219
|
Adverse Events
Oral B Indicator 123
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dr Best Original
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Dr Best Multi Expert
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Parodontax Interdental
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Oral B Indicator 123
n=20 participants at risk
Participants randomized to this group dosed the Oral B Indicator 123 toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Dr Best Original
n=19 participants at risk
Participants randomized to this group dosed the Dr Best Original toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Dr Best Multi Expert
n=20 participants at risk
Participants randomized to this group dosed the Dr Best Multi Expert toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
Parodontax Interdental
n=21 participants at risk
Participants randomized to this group dosed the parodontax Interdental toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 mL tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/20 • Up to 35 days
Safety population included all randomized participants who completed at least one use of study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
0.00%
0/19 • Up to 35 days
Safety population included all randomized participants who completed at least one use of study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
0.00%
0/20 • Up to 35 days
Safety population included all randomized participants who completed at least one use of study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
4.8%
1/21 • Number of events 1 • Up to 35 days
Safety population included all randomized participants who completed at least one use of study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
|
Injury, poisoning and procedural complications
Tooth injury
|
0.00%
0/20 • Up to 35 days
Safety population included all randomized participants who completed at least one use of study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
0.00%
0/19 • Up to 35 days
Safety population included all randomized participants who completed at least one use of study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
5.0%
1/20 • Number of events 1 • Up to 35 days
Safety population included all randomized participants who completed at least one use of study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
0.00%
0/21 • Up to 35 days
Safety population included all randomized participants who completed at least one use of study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/20 • Up to 35 days
Safety population included all randomized participants who completed at least one use of study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
0.00%
0/19 • Up to 35 days
Safety population included all randomized participants who completed at least one use of study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
0.00%
0/20 • Up to 35 days
Safety population included all randomized participants who completed at least one use of study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
4.8%
1/21 • Number of events 1 • Up to 35 days
Safety population included all randomized participants who completed at least one use of study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/20 • Up to 35 days
Safety population included all randomized participants who completed at least one use of study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
5.3%
1/19 • Number of events 1 • Up to 35 days
Safety population included all randomized participants who completed at least one use of study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
0.00%
0/20 • Up to 35 days
Safety population included all randomized participants who completed at least one use of study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
0.00%
0/21 • Up to 35 days
Safety population included all randomized participants who completed at least one use of study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/20 • Up to 35 days
Safety population included all randomized participants who completed at least one use of study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
5.3%
1/19 • Number of events 1 • Up to 35 days
Safety population included all randomized participants who completed at least one use of study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
0.00%
0/20 • Up to 35 days
Safety population included all randomized participants who completed at least one use of study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
0.00%
0/21 • Up to 35 days
Safety population included all randomized participants who completed at least one use of study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER