Dental Plaque, Oral Hygiene
Conditions
Keywords
Oral Hygiene
Brief summary
This clinical methodology development study will evaluate the plaque removal efficacy of four marketed manual toothbrushes, with differing bristle types and brush head designs, in healthy dentate participants. Changes in supra-gingival plaque accumulation will be assessed after first use and following 1-and 4-weeks treatment (twice-daily brushing), using two different clinical measures of dental plaque. Study participants will abstain from oral hygiene for a period of 12-18 hours prior to each assessment visit. Data generated will inform the design of future clinical studies investigating the plaque removal efficacy of manual toothbrushes.
Detailed description
This will be a single center, 4-week, randomized, controlled, examiner-blind, four-treatment arm, parallel design, clinical methodology development study to investigate the plaque removal efficacy of marketed manual toothbrushes in healthy, dentate participants. Changes in plaque level will be evaluated after first brushing, after two further single brushing events (Days 7 and 28) and following 7 and 28 days usage (twice daily brushing with assigned toothbrush treatment). Supra-gingival plaque levels will be assessed using two established clinical measures: the Rustogi Modified Navy Plaque Index (RPI) and the 6-site Turesky Modified Quigley and Hein Plaque Index (TPI). Participants will abstain from oral hygiene for a period of 12-18 hours prior to each assessment visit. Participants with Day 0 pre-brushing mean RPI overall ≥ 0.6 will be stratified by their Day 0 pre-brushing RPI score (lower: mean RPI overall ≥ 0.6 to ≤ 0.8; higher: mean RPI overall; 0.8 to 1.0) and randomized to study treatment (Visit 2). To standardize oral hygiene practice, eligible participants will complete a lead-in period (minimum 5 days) prior to Visit 2 during which they will brush with the toothbrush and regular fluoride toothpaste provided. The safety and oral tolerability of each study toothbrush will be monitored after first use and over the 28-day usage period by review of reported treatment emergent adverse events (TEAEs).
Interventions
OTHEROral B Indicator 123
Manual toothbrush (medium bristle stiffness; compact head, UK market).
OTHERDr Best Original
Manual toothbrush (medium bristle stiffness; regular head, German market)
OTHERDr Best Multi Expert
Manual toothbrush (medium bristle stiffness; compact head, German market)
OTHERparodontax Interdental
Manual toothbrush (soft bristle stiffness; compact head, German market)
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Examiner-blind; Monitor and Data-analyst
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
An individual must meet all the following inclusion criteria to be eligible for enrollment into the study. * Participant provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed. * A participant who is willing and able to comply with scheduled visits, treatment plan and other study procedures. * A participant in good general, mental and oral health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history or upon oral examination, or condition, that would impact the participant's safety, well-being or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements. * A participant with, in the opinion of the investigator or medically qualified designee, satisfactory oral hygiene based on oral examination. * A participant who routinely uses a manual toothbrush for daily oral hygiene. * VISIT 1 (Screening): A participant must have a) ≥ 20 natural, permanent teeth b) ≥ 40 gradable tooth surfaces (≥ 2/3rds of the tooth surface assessable for RPI).Third molars, fully crowned/ extensively restored, grossly carious, orthodontically-banded/bonded or abutment teeth and surfaces with calculus deposits which, in the opinion of the clinical examiner, would interfere with plaque assessment should not be included in the gradable surface count. Third molars can be included if, as a result tooth loss, they are functioning as second molars. * VISIT 2 (Baseline): A participant must have a pre-brushing mean RPI ≥ 0.6 overall (that is, the mean over all gradable surfaces)
Exclusion criteria
An individual who meets any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Pre to Post Brushing in Overall Mean Rustogi Modified Navy Plaque Index (RPI) After a Single Brushing Event at Day 0 | At Day 0 | 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. |
| Change From Pre to Post Brushing in Overall Mean Turesky Modified Quigley & Hein Plaque Index (TPI) After a Single Brushing Event at Day 0 | At Day 0 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Mean Rustogi Modified Navy Plaque Index (RPI) Pre- and Post-brushing at Day 7 and Day 28 | At Day 7 and Day 28 | 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. |
| Overall Mean Turesky Modified Quigley & Hein Plaque Index (TPI) Pre- and Post-brushing TPI at Day 7, and Day 28 | At Day 7 and Day 28 | 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. |
| 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 | At Day 0, Day 7 and Day 28 | 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. |
| 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 | At Day 0, Day 7 and Day 28 | 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. |
| 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 | At Day 0, Day 7 and Day 28 | 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. |
| 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, Day 7 and Day 28 | 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. |
| 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 | At Day 0, Day 7 and Day 28 | 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. |
| 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, Day 7 and Day 28 | 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. |
| 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 0, Day 7 pre-brushing and Day 28 pre-brushing | 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. |
| 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 0, Day 7 pre-brushing and Day 28 pre-brushing | 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. |
| 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 0, Day 7 pre-brushing and Day 28 pre-brushing | 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. |
| 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 0, Day 7 pre-brushing and Day 28 pre-brushing | 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. |
| 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 0, Day 7 pre-brushing and Day 28 pre-brushing | 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. |
| 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, Day 7 and Day 28 | 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. |
| 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 | At Day 0, Day 7 and Day 28 | 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. |
Countries
United Kingdom
Participant flow
Recruitment details
The study was conducted at single center in United Kingdom.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 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. | 20 |
| 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. | 19 |
| 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. | 20 |
| 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. | 21 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Multiple reasons | 1 | 3 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Dr Best Original | Dr Best Multi Expert | Oral B Indicator 123 | Parodontax Interdental | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 20 Participants | 20 Participants | 20 Participants | 79 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 5 Participants | 1 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 4 Participants | 3 Participants | 1 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 15 Participants | 12 Participants | 19 Participants | 62 Participants |
| Sex: Female, Male Female | 12 Participants | 10 Participants | 14 Participants | 16 Participants | 52 Participants |
| Sex: Female, Male Male | 7 Participants | 10 Participants | 6 Participants | 5 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 19 | 0 / 20 | 0 / 21 |
| other Total, other adverse events | 0 / 20 | 2 / 19 | 1 / 20 | 1 / 21 |
| serious Total, serious adverse events | 0 / 20 | 0 / 19 | 0 / 20 | 0 / 21 |
Outcome results
Primary
Change From Pre to Post Brushing in Overall Mean Rustogi Modified Navy Plaque Index (RPI) After a Single Brushing Event at Day 0
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.
Time frame: At Day 0
Population: Modified intent-to-treat population (mITT) comprised all randomized participants who had a postbaseline plaque assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral B Indicator 123 | 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 |
| Dr Best Original | Change From Pre to Post Brushing in Overall Mean Rustogi Modified Navy Plaque Index (RPI) After a Single Brushing Event at Day 0 | -0.12005 score on a scale | Standard Deviation 0.05535 |
| Dr Best Multi Expert | Change From Pre to Post Brushing in Overall Mean Rustogi Modified Navy Plaque Index (RPI) After a Single Brushing Event at Day 0 | -0.09859 score on a scale | Standard Deviation 0.045509 |
| Parodontax Interdental | Change From Pre to Post Brushing in Overall Mean Rustogi Modified Navy Plaque Index (RPI) After a Single Brushing Event at Day 0 | -0.09599 score on a scale | Standard Deviation 0.044436 |
Comparison: Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.p-value: <0.000195% CI: [-0.11, -0.08]ANCOVA
Comparison: Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.p-value: <0.000195% CI: [-0.14, -0.1]ANCOVA
Comparison: Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.p-value: <0.000195% CI: [-0.12, -0.08]ANCOVA
Comparison: Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.p-value: <0.000195% CI: [-0.12, -0.08]ANCOVA
Primary
Change From Pre to Post Brushing in Overall Mean Turesky Modified Quigley & Hein Plaque Index (TPI) After a Single Brushing Event at Day 0
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.
Time frame: At Day 0
Population: mITT comprised all randomized participants who had a postbaseline plaque assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral B Indicator 123 | 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 |
| Dr Best Original | Change From Pre to Post Brushing in Overall Mean Turesky Modified Quigley & Hein Plaque Index (TPI) After a Single Brushing Event at Day 0 | -0.62218 Score on a scale | Standard Deviation 0.340491 |
| Dr Best Multi Expert | Change From Pre to Post Brushing in Overall Mean Turesky Modified Quigley & Hein Plaque Index (TPI) After a Single Brushing Event at Day 0 | -0.57721 Score on a scale | Standard Deviation 0.347314 |
| Parodontax Interdental | Change From Pre to Post Brushing in Overall Mean Turesky Modified Quigley & Hein Plaque Index (TPI) After a Single Brushing Event at Day 0 | -0.53714 Score on a scale | Standard Deviation 0.27372 |
Comparison: Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.p-value: <0.000195% CI: [-0.62, -0.37]ANCOVA
Comparison: Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.p-value: <0.000195% CI: [-0.75, -0.49]ANCOVA
Comparison: Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.p-value: <0.000195% CI: [-0.68, -0.42]ANCOVA
Comparison: Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group.p-value: <0.000195% CI: [-0.7, -0.44]ANCOVA
Secondary
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
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.
Time frame: At Day 0, Day 7 pre-brushing and Day 28 pre-brushing
Population: mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral B Indicator 123 | 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 |
| Oral B Indicator 123 | 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 |
| Dr Best Original | 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 | -0.01355 score on a scale | Standard Deviation 0.034877 |
| Dr Best Original | 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 | -0.03645 score on a scale | Standard Deviation 0.066621 |
| Dr Best Multi Expert | 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 | -0.01378 score on a scale | Standard Deviation 0.040284 |
| Dr Best Multi Expert | 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 | -0.00943 score on a scale | Standard Deviation 0.026501 |
| Parodontax Interdental | 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 | -0.01219 score on a scale | Standard Deviation 0.038447 |
| Parodontax Interdental | 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 | -0.01715 score on a scale | Standard Deviation 0.083641 |
Secondary
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
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.
Time frame: At Day 0, Day 7 pre-brushing and Day 28 pre-brushing
Population: mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral B Indicator 123 | 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 |
| Oral B Indicator 123 | 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 |
| Dr Best Original | 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 | -0.09659 score on a scale | Standard Deviation 0.197697 |
| Dr Best Original | 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 | -0.15199 score on a scale | Standard Deviation 0.162624 |
| Dr Best Multi Expert | 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 | -0.05413 score on a scale | Standard Deviation 0.144292 |
| Dr Best Multi Expert | 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 | -0.02755 score on a scale | Standard Deviation 0.204586 |
| Parodontax Interdental | 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 | -0.05919 score on a scale | Standard Deviation 0.175623 |
| Parodontax Interdental | 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 | -0.08592 score on a scale | Standard Deviation 0.215974 |
Secondary
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
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.
Time frame: At Day 0, Day 7 pre-brushing and Day 28 pre-brushing
Population: mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral B Indicator 123 | 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 |
| Oral B Indicator 123 | 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 |
| Dr Best Original | 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 | -0.17761 Score on a scale | Standard Deviation 0.225399 |
| Dr Best Original | 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 | -0.21666 Score on a scale | Standard Deviation 0.366396 |
| Dr Best Multi Expert | 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 | -0.10226 Score on a scale | Standard Deviation 0.31555 |
| Dr Best Multi Expert | 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 | -0.17561 Score on a scale | Standard Deviation 0.327045 |
| Parodontax Interdental | 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 | 0.02326 Score on a scale | Standard Deviation 0.316914 |
| Parodontax Interdental | 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 | -0.09889 Score on a scale | Standard Deviation 0.370219 |
Secondary
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
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.
Time frame: At Day 0, Day 7 pre-brushing and Day 28 pre-brushing
Population: mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral B Indicator 123 | 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 |
| Oral B Indicator 123 | 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 |
| Dr Best Original | 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 | -0.12896 score on a scale | Standard Deviation 0.236209 |
| Dr Best Original | 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 | -0.20746 score on a scale | Standard Deviation 0.360506 |
| Dr Best Multi Expert | 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 | -0.07029 score on a scale | Standard Deviation 0.315099 |
| Dr Best Multi Expert | 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 | -0.12756 score on a scale | Standard Deviation 0.302698 |
| Parodontax Interdental | 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 | 0.01187 score on a scale | Standard Deviation 0.282108 |
| Parodontax Interdental | 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 | -0.08991 score on a scale | Standard Deviation 0.357293 |
Secondary
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
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.
Time frame: At Day 0, Day 7 pre-brushing and Day 28 pre-brushing
Population: mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral B Indicator 123 | 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 |
| Oral B Indicator 123 | 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 |
| Dr Best Original | 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 | -0.03796 score on a scale | Standard Deviation 0.060434 |
| Dr Best Original | 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 | -0.06178 score on a scale | Standard Deviation 0.058426 |
| Dr Best Multi Expert | 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 | -0.01992 score on a scale | Standard Deviation 0.050254 |
| Dr Best Multi Expert | 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 | -0.02121 score on a scale | Standard Deviation 0.06178 |
| Parodontax Interdental | 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 | -0.02163 score on a scale | Standard Deviation 0.056758 |
| Parodontax Interdental | 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 | -0.03689 score on a scale | Standard Deviation 0.07567 |
Secondary
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
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.
Time frame: At Day 0, Day 7 and Day 28
Population: mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral B Indicator 123 | 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 |
| Oral B Indicator 123 | 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 |
| Oral B Indicator 123 | 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 |
| Dr Best Original | 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 | -0.09034 score on a scale | Standard Deviation 0.092453 |
| Dr Best Original | 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 | -0.16314 score on a scale | Standard Deviation 0.156324 |
| Dr Best Original | 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 | -0.16961 score on a scale | Standard Deviation 0.132531 |
| Dr Best Multi Expert | 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 | -0.09456 score on a scale | Standard Deviation 0.095039 |
| Dr Best Multi Expert | 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 | -0.05344 score on a scale | Standard Deviation 0.059657 |
| Dr Best Multi Expert | 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 | -0.12075 score on a scale | Standard Deviation 0.123455 |
| Parodontax Interdental | 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 | -0.07211 score on a scale | Standard Deviation 0.05888 |
| Parodontax Interdental | 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 | -0.10500 score on a scale | Standard Deviation 0.110297 |
| Parodontax Interdental | 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 | -0.12165 score on a scale | Standard Deviation 0.089975 |
Secondary
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
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.
Time frame: At Day 0, Day 7 and Day 28
Population: mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral B Indicator 123 | 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 0.15308 |
| Oral B Indicator 123 | 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 |
| Oral B Indicator 123 | 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 |
| Dr Best Original | 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 | -0.33171 score on a scale | Standard Deviation 0.188937 |
| Dr Best Original | 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 | -0.28219 score on a scale | Standard Deviation 0.133379 |
| Dr Best Original | 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 | -0.32138 score on a scale | Standard Deviation 0.130552 |
| Dr Best Multi Expert | 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 | -0.21269 score on a scale | Standard Deviation 0.167972 |
| Dr Best Multi Expert | 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 | -0.25775 score on a scale | Standard Deviation 0.123545 |
| Dr Best Multi Expert | 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 | -0.26825 score on a scale | Standard Deviation 0.188777 |
| Parodontax Interdental | 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 | -0.22865 score on a scale | Standard Deviation 0.13083 |
| Parodontax Interdental | 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 | -0.25411 score on a scale | Standard Deviation 0.191171 |
| Parodontax Interdental | 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 | -0.24499 score on a scale | Standard Deviation 0.172251 |
Secondary
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
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.
Time frame: At Day 0, Day 7 and Day 28
Population: mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral B Indicator 123 | 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 |
| Oral B Indicator 123 | 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 |
| Oral B Indicator 123 | 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 |
| Dr Best Original | 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 | -0.60975 score on a scale | Standard Deviation 0.337375 |
| Dr Best Original | 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 | -0.81581 score on a scale | Standard Deviation 0.261399 |
| Dr Best Original | 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 | -0.89035 score on a scale | Standard Deviation 0.429582 |
| Dr Best Multi Expert | 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 | -0.62843 score on a scale | Standard Deviation 0.400444 |
| Dr Best Multi Expert | 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 | -0.58666 score on a scale | Standard Deviation 0.352225 |
| Dr Best Multi Expert | 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 | -0.72924 score on a scale | Standard Deviation 0.445553 |
| Parodontax Interdental | 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 | -0.49861 score on a scale | Standard Deviation 0.291868 |
| Parodontax Interdental | 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 | -0.58135 score on a scale | Standard Deviation 0.38949 |
| Parodontax Interdental | 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 | -0.56209 score on a scale | Standard Deviation 0.365074 |
Secondary
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
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.
Time frame: At Day 0, Day 7 and Day 28
Population: mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral B Indicator 123 | 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 |
| Oral B Indicator 123 | 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 |
| Dr Best Original | 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 | -0.16234 score on a scale | Standard Deviation 0.047753 |
| Dr Best Original | 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 | -0.16648 score on a scale | Standard Deviation 0.074227 |
| Dr Best Multi Expert | 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 | -0.09813 score on a scale | Standard Deviation 0.068715 |
| Dr Best Multi Expert | 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 | -0.12854 score on a scale | Standard Deviation 0.085085 |
| Parodontax Interdental | 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 | -0.11839 score on a scale | Standard Deviation 0.059674 |
| Parodontax Interdental | 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 | -0.11835 score on a scale | Standard Deviation 0.07086 |
Secondary
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
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.
Time frame: At Day 0, Day 7 and Day 28
Population: mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral B Indicator 123 | 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 |
| Oral B Indicator 123 | 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 |
| Dr Best Original | 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 | -0.79959 score on a scale | Standard Deviation 0.28152 |
| Dr Best Original | 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 | -0.90569 score on a scale | Standard Deviation 0.436986 |
| Dr Best Multi Expert | 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 | -0.63582 score on a scale | Standard Deviation 0.417132 |
| Dr Best Multi Expert | 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 | -0.70769 score on a scale | Standard Deviation 0.43826 |
| Parodontax Interdental | 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 | -0.61935 score on a scale | Standard Deviation 0.348844 |
| Parodontax Interdental | 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 | -0.60327 score on a scale | Standard Deviation 0.379847 |
Secondary
Gingival Margin Sites Mean Rustogi Modified Navy Plaque Index (RPI) Pre- and Post-brushing at Day 0, Day 7 and Day 28
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.
Time frame: At Day 0, Day 7 and Day 28
Population: mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral B Indicator 123 | 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 |
| Oral B Indicator 123 | 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 |
| Oral B Indicator 123 | 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 |
| Oral B Indicator 123 | 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 |
| Oral B Indicator 123 | 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 |
| Oral B Indicator 123 | 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 |
| Dr Best Original | 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 | 0.825 score on a scale | Standard Deviation 0.1686 |
| Dr Best Original | 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 | 0.818 score on a scale | Standard Deviation 0.1429 |
| Dr Best Original | 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 | 0.987 score on a scale | Standard Deviation 0.0213 |
| Dr Best Original | 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 | 0.952 score on a scale | Standard Deviation 0.0831 |
| Dr Best Original | 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 | 0.896 score on a scale | Standard Deviation 0.0932 |
| Dr Best Original | 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 | 0.974 score on a scale | Standard Deviation 0.0436 |
| Dr Best Multi Expert | 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 0.0577 |
| Dr Best Multi Expert | 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 | 0.978 score on a scale | Standard Deviation 0.0376 |
| Dr Best Multi Expert | 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 | 0.898 score on a scale | Standard Deviation 0.0931 |
| Dr Best Multi Expert | 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 | 0.871 score on a scale | Standard Deviation 0.1218 |
| Dr Best Multi Expert | 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 | 0.983 score on a scale | Standard Deviation 0.0252 |
| Dr Best Multi Expert | 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 | 0.992 score on a scale | Standard Deviation 0.0115 |
| Parodontax Interdental | 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 | 0.964 score on a scale | Standard Deviation 0.0657 |
| Parodontax Interdental | 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 | 0.876 score on a scale | Standard Deviation 0.1127 |
| Parodontax Interdental | 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 | 0.909 score on a scale | Standard Deviation 0.0894 |
| Parodontax Interdental | 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 | 0.859 score on a scale | Standard Deviation 0.1056 |
| Parodontax Interdental | 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 | 0.981 score on a scale | Standard Deviation 0.0481 |
| Parodontax Interdental | 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 | 0.969 score on a scale | Standard Deviation 0.0406 |
Secondary
Inter-Proximal Sites Mean Rustogi Modified Navy Plaque Index (RPI) Pre- and Post-brushing at Day 0, Day 7 and Day 28
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.
Time frame: At Day 0, Day 7 and Day 28
Population: mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral B Indicator 123 | 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 |
| Oral B Indicator 123 | 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 |
| Oral B Indicator 123 | 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 |
| Oral B Indicator 123 | 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 |
| Oral B Indicator 123 | 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 |
| Oral B Indicator 123 | 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 |
| Dr Best Original | 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 | 0.217 score on a scale | Standard Deviation 0.1478 |
| Dr Best Original | 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 | 0.191 score on a scale | Standard Deviation 0.108 |
| Dr Best Original | 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 | 0.499 score on a scale | Standard Deviation 0.2217 |
| Dr Best Original | 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 | 0.371 score on a scale | Standard Deviation 0.2083 |
| Dr Best Original | 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 | 0.217 score on a scale | Standard Deviation 0.1611 |
| Dr Best Original | 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 | 0.442 score on a scale | Standard Deviation 0.2341 |
| Dr Best Multi Expert | 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 | 0.249 score on a scale | Standard Deviation 0.1422 |
| Dr Best Multi Expert | 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 | 0.453 score on a scale | Standard Deviation 0.1969 |
| Dr Best Multi Expert | 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 | 0.294 score on a scale | Standard Deviation 0.2048 |
| Dr Best Multi Expert | 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 | 0.239 score on a scale | Standard Deviation 0.1666 |
| Dr Best Multi Expert | 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 | 0.479 score on a scale | Standard Deviation 0.237 |
| Dr Best Multi Expert | 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 | 0.507 score on a scale | Standard Deviation 0.1626 |
| Parodontax Interdental | 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 | 0.381 score on a scale | Standard Deviation 0.2083 |
| Parodontax Interdental | 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 | 0.213 score on a scale | Standard Deviation 0.164 |
| Parodontax Interdental | 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 | 0.238 score on a scale | Standard Deviation 0.1397 |
| Parodontax Interdental | 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 | 0.222 score on a scale | Standard Deviation 0.1187 |
| Parodontax Interdental | 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 | 0.467 score on a scale | Standard Deviation 0.191 |
| Parodontax Interdental | 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 | 0.408 score on a scale | Standard Deviation 0.1668 |
Secondary
Inter-Proximal Sites Mean Turesky Modified Quigley & Hein Plaque Index (TPI) Pre- and Post-brushing TPI at Day 0, Day 7 and Day 28
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.
Time frame: At Day 0, Day 7 and Day 28
Population: mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral B Indicator 123 | 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 |
| Oral B Indicator 123 | 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 |
| Oral B Indicator 123 | 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 |
| Oral B Indicator 123 | 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 |
| Oral B Indicator 123 | 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 |
| Oral B Indicator 123 | 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 |
| Dr Best Original | 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 | 1.911 score on a scale | Standard Deviation 0.4994 |
| Dr Best Original | 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 | 1.821 score on a scale | Standard Deviation 0.4075 |
| Dr Best Original | 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 | 2.649 score on a scale | Standard Deviation 0.4338 |
| Dr Best Original | 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 | 2.493 score on a scale | Standard Deviation 0.4949 |
| Dr Best Original | 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 | 2.041 score on a scale | Standard Deviation 0.3815 |
| Dr Best Original | 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 | 2.550 score on a scale | Standard Deviation 0.3968 |
| Dr Best Multi Expert | 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 | 2.149 score on a scale | Standard Deviation 0.2642 |
| Dr Best Multi Expert | 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 | 2.635 score on a scale | Standard Deviation 0.4564 |
| Dr Best Multi Expert | 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 | 2.109 score on a scale | Standard Deviation 0.5191 |
| Dr Best Multi Expert | 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 | 2.007 score on a scale | Standard Deviation 0.4122 |
| Dr Best Multi Expert | 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 | 2.561 score on a scale | Standard Deviation 0.2938 |
| Dr Best Multi Expert | 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 | 2.737 score on a scale | Standard Deviation 0.3425 |
| Parodontax Interdental | 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 | 2.454 score on a scale | Standard Deviation 0.3358 |
| Parodontax Interdental | 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 | 1.972 score on a scale | Standard Deviation 0.4141 |
| Parodontax Interdental | 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 | 2.054 score on a scale | Standard Deviation 0.4217 |
| Parodontax Interdental | 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 | 1.991 score on a scale | Standard Deviation 0.3755 |
| Parodontax Interdental | 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 | 2.552 score on a scale | Standard Deviation 0.4292 |
| Parodontax Interdental | 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 | 2.577 score on a scale | Standard Deviation 0.4149 |
Secondary
Overall Mean Rustogi Modified Navy Plaque Index (RPI) Pre- and Post-brushing at Day 7 and Day 28
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.
Time frame: At Day 7 and Day 28
Population: mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral B Indicator 123 | 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 |
| Oral B Indicator 123 | 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 |
| Oral B Indicator 123 | 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 0.092 |
| Oral B Indicator 123 | 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 |
| Dr Best Original | Overall Mean Rustogi Modified Navy Plaque Index (RPI) Pre- and Post-brushing at Day 7 and Day 28 | At Day 28 Post-brushing | 0.343 score on a scale | Standard Deviation 0.0974 |
| Dr Best Original | Overall Mean Rustogi Modified Navy Plaque Index (RPI) Pre- and Post-brushing at Day 7 and Day 28 | At Day 28 Pre-brushing | 0.467 score on a scale | Standard Deviation 0.0888 |
| Dr Best Original | Overall Mean Rustogi Modified Navy Plaque Index (RPI) Pre- and Post-brushing at Day 7 and Day 28 | At Day 7 Post-brushing | 0.333 score on a scale | Standard Deviation 0.0749 |
| Dr Best Original | Overall Mean Rustogi Modified Navy Plaque Index (RPI) Pre- and Post-brushing at Day 7 and Day 28 | At Day 7 Pre-brushing | 0.438 score on a scale | Standard Deviation 0.0859 |
| Dr Best Multi Expert | Overall Mean Rustogi Modified Navy Plaque Index (RPI) Pre- and Post-brushing at Day 7 and Day 28 | At Day 28 Pre-brushing | 0.467 score on a scale | Standard Deviation 0.0721 |
| Dr Best Multi Expert | Overall Mean Rustogi Modified Navy Plaque Index (RPI) Pre- and Post-brushing at Day 7 and Day 28 | At Day 28 Post-brushing | 0.360 score on a scale | Standard Deviation 0.0802 |
| Dr Best Multi Expert | Overall Mean Rustogi Modified Navy Plaque Index (RPI) Pre- and Post-brushing at Day 7 and Day 28 | At Day 7 Post-brushing | 0.390 score on a scale | Standard Deviation 0.0924 |
| Dr Best Multi Expert | Overall Mean Rustogi Modified Navy Plaque Index (RPI) Pre- and Post-brushing at Day 7 and Day 28 | At Day 7 Pre-brushing | 0.468 score on a scale | Standard Deviation 0.0738 |
| Parodontax Interdental | Overall Mean Rustogi Modified Navy Plaque Index (RPI) Pre- and Post-brushing at Day 7 and Day 28 | At Day 28 Post-brushing | 0.352 score on a scale | Standard Deviation 0.0736 |
| Parodontax Interdental | Overall Mean Rustogi Modified Navy Plaque Index (RPI) Pre- and Post-brushing at Day 7 and Day 28 | At Day 7 Pre-brushing | 0.449 score on a scale | Standard Deviation 0.0654 |
| Parodontax Interdental | 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 0.0681 |
| Parodontax Interdental | Overall Mean Rustogi Modified Navy Plaque Index (RPI) Pre- and Post-brushing at Day 7 and Day 28 | At Day 28 Pre-brushing | 0.434 score on a scale | Standard Deviation 0.0756 |
Secondary
Overall Mean Turesky Modified Quigley & Hein Plaque Index (TPI) Pre- and Post-brushing TPI at Day 7, and Day 28
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.
Time frame: At Day 7 and Day 28
Population: mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral B Indicator 123 | 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 |
| Oral B Indicator 123 | 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 |
| Oral B Indicator 123 | 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 |
| Oral B Indicator 123 | 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 |
| Dr Best Original | 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 | 1.669 score on a scale | Standard Deviation 0.4246 |
| Dr Best Original | 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 | 2.459 score on a scale | Standard Deviation 0.4062 |
| Dr Best Original | 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 | 1.788 score on a scale | Standard Deviation 0.5161 |
| Dr Best Original | 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 | 2.368 score on a scale | Standard Deviation 0.5218 |
| Dr Best Multi Expert | 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 | 2.452 score on a scale | Standard Deviation 0.2773 |
| Dr Best Multi Expert | 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 | 1.945 score on a scale | Standard Deviation 0.5175 |
| Dr Best Multi Expert | 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 | 1.870 score on a scale | Standard Deviation 0.4209 |
| Dr Best Multi Expert | 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 | 2.508 score on a scale | Standard Deviation 0.427 |
| Parodontax Interdental | 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 | 1.832 score on a scale | Standard Deviation 0.433 |
| Parodontax Interdental | 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 | 1.816 score on a scale | Standard Deviation 0.3902 |
| Parodontax Interdental | 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 | 2.446 score on a scale | Standard Deviation 0.3834 |
| Parodontax Interdental | 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 | 2.346 score on a scale | Standard Deviation 0.3421 |