An interventional study of Oral B Indicator 123 and Dr Best Original in Dental Plaque and Oral Hygiene, sponsored by GlaxoSmithKline. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-28.
Sponsored by GlaxoSmithKline · Not applicable, Interventional, and Other
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.
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).
314 studies on the registry are indexed under Dental Plaque; 54 are open to participants now.
This study's enrollment of 80 is above the median of 59 across 279 interventional studies indexed under Dental Plaque.
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Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
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An individual must meet all the following inclusion criteria to be eligible for enrollment into the study.
Exclusion Criteria:
An individual who meets any of the following exclusion criteria will not be eligible for enrollment into the study.
Participants will brush their entire dentition twice daily (morning and evening) for 1-timed minute with test toothbrush 1 after applying a strip of standard fluoride (1450 parts per million \[ppm\] fluoride) toothpaste (full brush head) and will then rinse with 10 mL of water post brushing for 5 seconds (on site). Offsite participants will be permitted to rinse with tap water according to their normal habitat.
Other: Oral B Indicator 123
Participants will brush their entire dentition twice daily (morning and evening) for 1-timed minute with test toothbrush 2 after applying a strip of standard fluoride (1450 ppm fluoride) toothpaste (full brush head) and will then rinse with 10 mL of water post brushing for 5 seconds (on site). Offsite participants will be permitted to rinse with tap water according to their normal habitat.
Other: Dr Best Original
Participants will brush their entire dentition twice daily (morning and evening) for 1-timed minute with test toothbrush 3 after applying a strip of standard fluoride (1450 ppm fluoride) toothpaste (full brush head) and will then rinse with 10 mL of water post brushing for 5 seconds (on site). Offsite participants will be permitted to rinse with tap water according to their normal habitat.
Other: Dr Best Multi Expert
Participants will brush their entire dentition twice daily (morning and evening) for 1-timed minute with test toothbrush 4 after applying a strip of standard fluoride (1450 ppm fluoride) toothpaste (full brush head) and will then rinse with 10 mL of water post brushing for 5 seconds (on site). Offsite participants will be permitted to rinse with tap water according to their normal habitat.
Other: parodontax Interdental
Manual toothbrush (medium bristle stiffness; compact head, UK market).
Manual toothbrush (medium bristle stiffness; regular head, German market)
Manual toothbrush (medium bristle stiffness; compact head, German market)
Manual toothbrush (soft bristle stiffness; compact head, German market)
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
The study was conducted at single center in United Kingdom.
| Milestone | Oral B Indicator 123 | Dr Best Original | Dr Best Multi Expert | Parodontax Interdental |
|---|---|---|---|---|
| Started | 20 | 19 | 20 | 21 |
| Completed | 18 | 15 | 20 | 20 |
| Not completed | 2 | 4 | 0 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 | 0 | 0 |
| Withdrew: Multiple reasons | 1 | 3 | 0 | 1 |
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.
| score on a scale | Oral B Indicator 123 | Dr Best Original | Dr Best Multi Expert | 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 | -0.09623 ± 0.052741 | -0.12005 ± 0.055350 | -0.09859 ± 0.045509 | -0.09599 ± 0.044436 |
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.
| Score on a scale | Oral B Indicator 123 | Dr Best Original | Dr Best Multi Expert | 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 | -0.49354 ± 0.312963 | -0.62218 ± 0.340491 | -0.57721 ± 0.347314 | -0.53714 ± 0.273720 |
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.
| score on a scale | Oral B Indicator 123 | Dr Best Original | Dr Best Multi Expert | Parodontax Interdental |
|---|---|---|---|---|
| Change at Day 7 Post brushing | -0.13485 ± 0.057076 | -0.16648 ± 0.074227 | -0.09813 ± 0.068715 | -0.11839 ± 0.059674 |
| Change at Day 28 Post brushing | -0.14738 ± 0.071082 | -0.16234 ± 0.047753 | -0.12854 ± 0.085085 | -0.11835 ± 0.070860 |
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.
| score on a scale | Oral B Indicator 123 | Dr Best Original | Dr Best Multi Expert | Parodontax Interdental |
|---|---|---|---|---|
| Change at Day 7 Post brushing | -0.71646 ± 0.290669 | -0.90569 ± 0.436986 | -0.63582 ± 0.417132 | -0.61935 ± 0.348844 |
| Change at Day 28 Post brushing | -0.75755 ± 0.330047 | -0.79959 ± 0.281520 | -0.70769 ± 0.438260 | -0.60327 ± 0.379847 |
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.
| score on a scale | Oral B Indicator 123 | Dr Best Original | Dr Best Multi Expert | Parodontax Interdental |
|---|---|---|---|---|
| At Day 7 Pre-brushing | 0.443 ± 0.0739 | 0.438 ± 0.0859 | 0.468 ± 0.0738 | 0.449 ± 0.0654 |
| At Day 7 Post-brushing | 0.352 ± 0.0695 | 0.333 ± 0.0749 | 0.390 ± 0.0924 | 0.352 ± 0.0681 |
| At Day 28 Pre-brushing | 0.443 ± 0.0920 | 0.467 ± 0.0888 | 0.467 ± 0.0721 | 0.434 ± 0.0756 |
| At Day 28 Post-brushing | 0.340 ± 0.1113 | 0.343 ± 0.0974 | 0.360 ± 0.0802 | 0.352 ± 0.0736 |
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.
| score on a scale | Oral B Indicator 123 | Dr Best Original | Dr Best Multi Expert | Parodontax Interdental |
|---|---|---|---|---|
| At Day 7 Pre-brushing | 2.361 ± 0.4198 | 2.368 ± 0.5218 | 2.508 ± 0.4270 | 2.446 ± 0.3834 |
| At Day 7 Post-brushing | 1.803 ± 0.4084 | 1.669 ± 0.4246 | 1.945 ± 0.5175 | 1.816 ± 0.3902 |
| At Day 28 Pre-brushing | 2.327 ± 0.5263 | 2.459 ± 0.4062 | 2.452 ± 0.2773 | 2.346 ± 0.3421 |
| At Day 28 Post-brushing | 1.766 ± 0.5549 | 1.788 ± 0.5161 | 1.870 ± 0.4209 | 1.832 ± 0.4330 |
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.
| score on a scale | Oral B Indicator 123 | Dr Best Original | Dr Best Multi Expert | Parodontax Interdental |
|---|---|---|---|---|
| Change at Day 0 Post brushing | -0.04938 ± 0.054115 | -0.09034 ± 0.092453 | -0.05344 ± 0.059657 | -0.07211 ± 0.058880 |
| Change at Day 7 Post brushing | -0.12498 ± 0.096075 | -0.16961 ± 0.132531 | -0.09456 ± 0.095039 | -0.12165 ± 0.089975 |
| Change at Day 28 Post brushing | -0.17348 ± 0.152077 | -0.16314 ± 0.156324 | -0.12075 ± 0.123455 | -0.10500 ± 0.110297 |
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.
| score on a scale | Oral B Indicator 123 | Dr Best Original | Dr Best Multi Expert | Parodontax Interdental |
|---|---|---|---|---|
| Change at Day 0 Post brushing | -0.26809 ± 0.130993 | -0.28219 ± 0.133379 | -0.25775 ± 0.123545 | -0.22865 ± 0.130830 |
| Change at Day 7 Post brushing | -0.31485 ± 0.161214 | -0.33171 ± 0.188937 | -0.21269 ± 0.167972 | -0.24499 ± 0.172251 |
| Change at Day 28 Post brushing | -0.30399 ± 0.153080 | -0.32138 ± 0.130552 | -0.26825 ± 0.188777 | -0.25411 ± 0.191171 |
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.
| score on a scale | Oral B Indicator 123 | Dr Best Original | Dr Best Multi Expert | Parodontax Interdental |
|---|---|---|---|---|
| Change at Day 0 Post brushing | -0.49949 ± 0.314629 | -0.60975 ± 0.337375 | -0.58666 ± 0.352225 | -0.49861 ± 0.291868 |
| Change at Day 7 Post brushing | -0.72054 ± 0.293855 | -0.89035 ± 0.429582 | -0.62843 ± 0.400444 | -0.56209 ± 0.365074 |
| Change at Day 28 Post brushing | -0.78797 ± 0.326878 | -0.81581 ± 0.261399 | -0.72924 ± 0.445553 | -0.58135 ± 0.389490 |
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.
| score on a scale | Oral B Indicator 123 | Dr Best Original | Dr Best Multi Expert | Parodontax Interdental |
|---|---|---|---|---|
| At Day 0 Pre-brushing | 0.988 ± 0.0227 | 0.987 ± 0.0213 | 0.992 ± 0.0115 | 0.981 ± 0.0481 |
| At Day 0 Post-brushing | 0.939 ± 0.0635 | 0.896 ± 0.0932 | 0.939 ± 0.0577 | 0.909 ± 0.0894 |
| At Day 7 Pre-brushing | 0.966 ± 0.0488 | 0.952 ± 0.0831 | 0.978 ± 0.0376 | 0.969 ± 0.0406 |
| At Day 7 Post-brushing | 0.863 ± 0.1046 | 0.818 ± 0.1429 | 0.898 ± 0.0931 | 0.859 ± 0.1056 |
| At Day 28 Pre-brushing | 0.945 ± 0.1094 | 0.974 ± 0.0436 | 0.983 ± 0.0252 | 0.964 ± 0.0657 |
| At Day 28 Post-brushing | 0.814 ± 0.1625 | 0.825 ± 0.1686 | 0.871 ± 0.1218 | 0.876 ± 0.1127 |
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.
| score on a scale | Oral B Indicator 123 | Dr Best Original | Dr Best Multi Expert | Parodontax Interdental |
|---|---|---|---|---|
| At Day 0 Pre-brushing | 0.523 ± 0.2121 | 0.499 ± 0.2217 | 0.507 ± 0.1626 | 0.467 ± 0.1910 |
| At Day 0 Post-brushing | 0.255 ± 0.1551 | 0.217 ± 0.1611 | 0.249 ± 0.1422 | 0.238 ± 0.1397 |
| At Day 7 Pre-brushing | 0.389 ± 0.2041 | 0.371 ± 0.2083 | 0.453 ± 0.1969 | 0.408 ± 0.1668 |
| At Day 7 Post-brushing | 0.214 ± 0.1344 | 0.191 ± 0.1080 | 0.294 ± 0.2048 | 0.222 ± 0.1187 |
| At Day 28 Pre-brushing | 0.431 ± 0.2299 | 0.442 ± 0.2341 | 0.479 ± 0.2370 | 0.381 ± 0.2083 |
| At Day 28 Post-brushing | 0.227 ± 0.2136 | 0.217 ± 0.1478 | 0.239 ± 0.1666 | 0.213 ± 0.1640 |
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.
| score on a scale | Oral B Indicator 123 | Dr Best Original | Dr Best Multi Expert | Parodontax Interdental |
|---|---|---|---|---|
| At Day 0 Pre-brushing | 2.643 ± 0.3965 | 2.649 ± 0.4338 | 2.737 ± 0.3425 | 2.552 ± 0.4292 |
| At Day 0 Post-brushing | 2.141 ± 0.3735 | 2.041 ± 0.3815 | 2.149 ± 0.2642 | 2.054 ± 0.4217 |
| At Day 7 Pre-brushing | 2.481 ± 0.4396 | 2.493 ± 0.4949 | 2.635 ± 0.4564 | 2.577 ± 0.4149 |
| At Day 7 Post-brushing | 1.937 ± 0.4208 | 1.821 ± 0.4075 | 2.109 ± 0.5191 | 1.991 ± 0.3755 |
| At Day 28 Pre-brushing | 2.410 ± 0.5228 | 2.550 ± 0.3968 | 2.561 ± 0.2938 | 2.454 ± 0.3358 |
| At Day 28 Post-brushing | 1.871 ± 0.5645 | 1.911 ± 0.4994 | 2.007 ± 0.4122 | 1.972 ± 0.4141 |
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.
| score on a scale | Oral B Indicator 123 | Dr Best Original | Dr Best Multi Expert | Parodontax Interdental |
|---|---|---|---|---|
| At Day 7 Pre-brushing | -0.04465 ± 0.060772 | -0.06178 ± 0.058426 | -0.01992 ± 0.050254 | -0.02163 ± 0.056758 |
| At Day 28 Pre-brushing | -0.04420 ± 0.060384 | -0.03796 ± 0.060434 | -0.02121 ± 0.061780 | -0.03689 ± 0.075670 |
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.
| score on a scale | Oral B Indicator 123 | Dr Best Original | Dr Best Multi Expert | Parodontax Interdental |
|---|---|---|---|---|
| At Day 7 pre-brushing | -0.15663 ± 0.307019 | -0.20746 ± 0.360506 | -0.07029 ± 0.315099 | 0.01187 ± 0.282108 |
| At Day 28 pre-brushing | -0.19667 ± 0.343446 | -0.12896 ± 0.236209 | -0.12756 ± 0.302698 | -0.08991 ± 0.357293 |
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.
| score on a scale | Oral B Indicator 123 | Dr Best Original | Dr Best Multi Expert | Parodontax Interdental |
|---|---|---|---|---|
| At Day 7 pre-brushing | -0.02233 ± 0.035312 | -0.03645 ± 0.066621 | -0.01378 ± 0.040284 | -0.01219 ± 0.038447 |
| At Day 28 pre-brushing | -0.04272 ± 0.100638 | -0.01355 ± 0.034877 | -0.00943 ± 0.026501 | -0.01715 ± 0.083641 |
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.
| score on a scale | Oral B Indicator 123 | Dr Best Original | Dr Best Multi Expert | Parodontax Interdental |
|---|---|---|---|---|
| At Day 7 pre-brushing | -0.13944 ± 0.184635 | -0.15199 ± 0.162624 | -0.05413 ± 0.144292 | -0.05919 ± 0.175623 |
| At Day 28 pre-brushing | -0.09970 ± 0.132324 | -0.09659 ± 0.197697 | -0.02755 ± 0.204586 | -0.08592 ± 0.215974 |
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.
| Score on a scale | Oral B Indicator 123 | Dr Best Original | Dr Best Multi Expert | Parodontax Interdental |
|---|---|---|---|---|
| At Day 7 pre-brushing | -0.17652 ± 0.309335 | -0.21666 ± 0.366396 | -0.10226 ± 0.315550 | 0.02326 ± 0.316914 |
| At Day 28 pre-brushing | -0.25042 ± 0.332584 | -0.17761 ± 0.225399 | -0.17561 ± 0.327045 | -0.09889 ± 0.370219 |
Collected over Up to 35 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Oral B Indicator 123 | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Dr Best Original | 0/19 (0%) | 0/19 (0%) | 2/19 (10.5%) |
| Dr Best Multi Expert | 0/20 (0%) | 0/20 (0%) | 1/20 (5%) |
| Parodontax Interdental | 0/21 (0%) | 0/21 (0%) | 1/21 (4.8%) |
| Event | Oral B Indicator 123 | Dr Best Original | Dr Best Multi Expert | Parodontax Interdental |
|---|---|---|---|---|
| PharyngitisInfections and infestations | 0/20 | 1/19 | 0/20 | 0/21 |
| Pain in jawMusculoskeletal and connective tissue disorders | 0/20 | 1/19 | 0/20 | 0/21 |
| Tooth injuryInjury, poisoning and procedural complications | 0/20 | 0/19 | 1/20 | 0/21 |
| Tooth fractureInjury, poisoning and procedural complications | 0/20 | 0/19 | 0/20 | 1/21 |
| Gingival painGastrointestinal disorders | 0/20 | 0/19 | 0/20 | 1/21 |
Safety population included all randomized participants who completed at least one use of study product.
| Age, Categorical(Participants) | Oral B Indicator 123 | Dr Best Original | Dr Best Multi Expert | Parodontax Interdental | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 20 | 19 | 20 | 20 | 79 |
| >=65 years | 0 | 0 | 0 | 1 | 1 |
| Sex: Female, Male(Participants) | Oral B Indicator 123 | Dr Best Original | Dr Best Multi Expert | Parodontax Interdental | Total |
|---|---|---|---|---|---|
| Female | 14 | 12 | 10 | 16 | 52 |
| Male | 6 | 7 | 10 | 5 | 28 |
| Race (NIH/OMB)(Participants) | Oral B Indicator 123 | Dr Best Original | Dr Best Multi Expert | Parodontax Interdental | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 5 | 2 | 1 | 1 | 9 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 3 | 1 | 4 | 1 | 9 |
| White | 12 | 16 | 15 | 19 | 62 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Supporting information: Study protocol, Sap, Icf, Csr
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