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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test toothbrush 1 | Other | 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. |
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| Test toothbrush 2 | Other | 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. |
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| Test toothbrush 3 | Other | 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. |
|
| Test toothbrush 4 | Other | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral B Indicator 123 | Other | Manual toothbrush (medium bristle stiffness; compact head, UK market). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | At Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Birmingham | West Midlands | B5 7EG | United Kingdom |
IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of primary endpoints of the study.
Access is provided after a research proposal submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
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.
The study was conducted at single center in United Kingdom.
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral B Indicator 123 | Participants randomized to this group dosed the Oral B Indicator 123 toothbrush with a strip of regular fluoride toothpaste (full brush head) and then brushed their entire dentition for 1 timed minute, twice daily (morning and evening) and rinsed with 10 milliliters (mL) tap water post-brushing for 5 seconds while brushing on-site and with tap water post-brushing, according to their normal habit while brushing off-site. Overall study duration was 30 days. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Safety population included all randomized participants who completed at least one use of study product.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Modified intent-to-treat population (mITT) comprised all randomized participants who had a postbaseline plaque assessment. | Posted | Mean | Standard Deviation | score on a scale | At Day 0 |
|
Up to 35 days
Safety population included all randomized participants who completed at least one use of study product. All adverse events (AEs) were summarized by system organ class and preferred term. All treatment emergent AEs and serious adverse events (SAEs) were collected and reported. A participant with multiple occurrences of AEs counted once in AE category. A participant with multiple AEs within a primary system organ class was counted once in system organ class.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA version 22.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 16, 2019 | Nov 19, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 5, 2019 | Nov 19, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003773 | Dental Plaque |
| ID | Term |
|---|---|
| D003741 | Dental Deposits |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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Examiner-blind; Monitor and Data-analyst
|
| Dr Best Original | Other | Manual toothbrush (medium bristle stiffness; regular head, German market) |
|
| Dr Best Multi Expert | Other | Manual toothbrush (medium bristle stiffness; compact head, German market) |
|
| parodontax Interdental | Other | Manual toothbrush (soft bristle stiffness; compact head, German market) |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | At Day 0, Day 7 pre-brushing and Day 28 pre-brushing |
| Multiple reasons |
|
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Title |
|---|
| Description |
|---|
| OG000 | 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. |
| OG001 | 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. |
| OG002 | 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. |
| OG003 | 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. |
|
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| 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. | mITT comprised all randomized participants who had a postbaseline plaque assessment. | Posted | Mean | Standard Deviation | Score on a scale | At Day 0 |
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| 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. | mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category. | Posted | Mean | Standard Deviation | score on a scale | At Day 0, Day 7 and Day 28 |
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| 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. | mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category. | Posted | Mean | Standard Deviation | score on a scale | At Day 0, Day 7 and Day 28 |
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| 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. | mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category. | Posted | Mean | Standard Deviation | score on a scale | At Day 7 and Day 28 |
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| 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. | mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category. | Posted | Mean | Standard Deviation | score on a scale | At Day 7 and Day 28 |
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| 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. | mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category. | Posted | Mean | Standard Deviation | score on a scale | At Day 0, Day 7 and Day 28 |
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| 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. | mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category. | Posted | Mean | Standard Deviation | score on a scale | At Day 0, Day 7 and Day 28 |
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| 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. | mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category. | Posted | Mean | Standard Deviation | score on a scale | At Day 0, Day 7 and Day 28 |
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| 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. | mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category. | Posted | Mean | Standard Deviation | score on a scale | At Day 0, Day 7 and Day 28 |
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| 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. | mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category. | Posted | Mean | Standard Deviation | score on a scale | At Day 0, Day 7 and Day 28 |
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| 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. | mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category. | Posted | Mean | Standard Deviation | score on a scale | At Day 0, Day 7 and Day 28 |
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| 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. | mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category. | Posted | Mean | Standard Deviation | score on a scale | At Day 0, Day 7 pre-brushing and Day 28 pre-brushing |
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| 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. | mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category. | Posted | Mean | Standard Deviation | score on a scale | At Day 0, Day 7 pre-brushing and Day 28 pre-brushing |
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| 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. | mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category. | Posted | Mean | Standard Deviation | score on a scale | At Day 0, Day 7 pre-brushing and Day 28 pre-brushing |
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| 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. | mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category. | Posted | Mean | Standard Deviation | score on a scale | At Day 0, Day 7 pre-brushing and Day 28 pre-brushing |
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| 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. | mITT comprised all randomized participants who had a postbaseline plaque assessment. Here, number analyzed indicates participants with available data for each category. | Posted | Mean | Standard Deviation | Score on a scale | At Day 0, Day 7 pre-brushing and Day 28 pre-brushing |
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | 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. | 0 | 19 | 0 | 19 | 2 | 19 |
| EG002 | 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. | 0 | 20 | 0 | 20 | 1 | 20 |
| EG003 | 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. | 0 | 21 | 0 | 21 | 1 | 21 |
| Tooth injury | Injury, poisoning and procedural complications | MedDRA version 22.1 | Systematic Assessment |
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| Gingival pain | Gastrointestinal disorders | MedDRA version 22.1 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA version 22.1 | Systematic Assessment |
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| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA version 22.1 | Systematic Assessment |
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GSK agreements may vary with individual investigators but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
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Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group. |
| ANCOVA |
| <0.0001 |
Analysis was performed using ANCOVA model with product group as a fixed effect, and the baseline mean TPI overall value and RPI stratification level as covariates. |
| Adjusted Mean Change |
| -0.62 |
| Standard Error of the Mean |
| 0.066 |
| 2-Sided |
| 95 |
| -0.75 |
| -0.49 |
| Superiority |
| Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group. | ANCOVA | <0.0001 | Analysis was performed using ANCOVA model with product group as a fixed effect, and the baseline mean TPI overall value and RPI stratification level as covariates. | Adjusted Mean Change | -0.55 | Standard Error of the Mean | 0.066 | 2-Sided | 95 | -0.68 | -0.42 | Superiority |
| Statistical analysis was performed with comparison in pre-treatment and post-treatment within the treatment group. | ANCOVA | <0.0001 | Analysis was performed using ANCOVA model with product group as a fixed effect, and the baseline mean TPI overall value and RPI stratification level as covariates. | Adjusted Mean Change | -0.57 | Standard Error of the Mean | 0.066 | 2-Sided | 95 | -0.70 | -0.44 | Superiority |
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| Change at Day 28 Post brushing |
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| Change at Day 28 Post brushing |
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| At Day 7 Post-brushing |
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| At Day 28 Pre-brushing |
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| At Day 28 Post-brushing |
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| At Day 7 Post-brushing |
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| At Day 28 Pre-brushing |
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| At Day 28 Post-brushing |
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| Change at Day 7 Post brushing |
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| Change at Day 28 Post brushing |
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| Change at Day 7 Post brushing |
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| Change at Day 28 Post brushing |
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| Change at Day 7 Post brushing |
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| Change at Day 28 Post brushing |
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| At Day 0 Post-brushing |
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| At Day 7 Pre-brushing |
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| At Day 7 Post-brushing |
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| At Day 28 Pre-brushing |
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| At Day 28 Post-brushing |
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| At Day 0 Post-brushing |
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| At Day 7 Pre-brushing |
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| At Day 7 Post-brushing |
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| At Day 28 Pre-brushing |
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| At Day 28 Post-brushing |
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| At Day 0 Post-brushing |
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| At Day 7 Pre-brushing |
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| At Day 7 Post-brushing |
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| At Day 28 Pre-brushing |
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| At Day 28 Post-brushing |
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| At Day 28 Pre-brushing |
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| At Day 28 pre-brushing |
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| At Day 28 pre-brushing |
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| At Day 28 pre-brushing |
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| At Day 28 pre-brushing |
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