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The aim of this study is to evaluate the ability of a prototype power toothbrush (PTB) versus a manual toothbrush in healthy, right-handed manual toothbrush (MTB) participants with no signs of periodontal disease or excessive recession to remove dental plaque after a single tooth brushing event. Prior to each treatment visit, participants will abstain from oral hygiene for a period of 12 hours preceding a pre-brushing dental plaque evaluation. Participants will then brush once under supervision for 2 minutes in 'Gum line' mode and 1-minute in 'Interdental' mode after which re-disclosing and a post-brushing plaque assessment will be carried out.
This study is an exploratory, randomized, single center, 4-treatment, 3-period, partial crossover study in healthy participants with no signs of periodontal disease or excessive recession, to assess a prototype PTB in removing dental plaque after a single brushing event.
At the screening visit, following provision of written informed consent, participants will be provided PTB training to familiarize themselves with how the different modes and different PTBs operate. Eligible participants will be provided with a washout fluoride toothpaste and toothbrush for use at home during the study.
Participants will then be scheduled to attend appointment after a minimum of 3 days. For each treatment visit, participants must abstain from oral hygiene for a period of 12hours, immediately preceding the pre-brushing dental plaque evaluation.
All the participants will undergo an oral soft tissue (OST) examination followed by plaque disclosing and a pre-brushing dental plaque assessment using the Rustogi Modified Navy Plaque Index (RMNPI) index. In in periods 1 and 2, participants will be randomized to the study treatment sequence with the prototype PTB and MTB used in a crossover manner and participants will then brush under supervision followed by disclosing and post-brushing plaque assessments. Participants assigned to the prototype PTB, it will be used for 2 minutes in 'Gum line' mode brushing and 1-minute brushing in 'Interdental' mode.
Participants will then brush once (1.3 grams [g] ± 0.1 g of assigned toothpaste), under supervision of study staff after which disclosing, and a post-brushing plaque assessment will be carried out.
Participants will be allowed to brush with the washout paste following the post assessment plaque assessments. A minimum of three days washout period will follow each treatment period during which period Participants will brush with a standard washout toothpaste
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prototype PTB (Gum line mode) | Experimental | Participants will brush their teeth with prototype power toothbrush in Gum line mode with a fluoride toothpaste |
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| Prototype PTB (Combined mode) | Experimental | Participants will brush their teeth with prototype power toothbrush in "Gum line" mode with a fluoride toothpaste. Following this, participants will brush their teeth with prototype power toothbrush in 'Interdental' mode with a fluoride toothpaste. |
|
| Reference MTB | Sham Comparator | Participants will brush their teeth with manual toothbrush and fluoride toothpaste. |
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| Reference PTB | Active Comparator | Participants will brush their teeth with reference power toothbrush and fluoride toothpaste. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reference MTB | Device | Participants will brush their teeth with manual toothbrush and 1.3 g ± 0.1 g of fluoride toothpaste (containing 0.76% w/w sodium monofluorophosphate) for 1-timed minute under supervision of study staff. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Whole Mouth Rustogi Modified Navy Plaque Index (RMNPI) Score From Pre-Brushing to Post-Brushing (When Prototype Power Toothbrush [PTB] Was Used in 'Gumline' Mode vs a Reference Manual Toothbrush [MTB]) | Change in plaque removal efficacy from pre-brushing to post-brushing in whole mouth (sites A to I) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' mode versus a reference MTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score). | After 2 minutes of brushing |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Marginal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs a Reference MTB) | Change in plaque removal efficacy from pre-brushing to post-brushing at the gum line (referred as marginal score-sites A to C) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' mode versus a reference MTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score). |
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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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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Mississauga | L5N 6J2 | Canada |
Participants received 4 treatments in 3 periods: 1. Prototype power toothbrush (PTB) in 'Gumline' mode, 2. Prototype PTB in 'Combined' mode ('Gumline' mode followed by 'Interdental' mode), 3. Reference manual toothbrush (MTB), 4. Reference PTB
The study was conducted at single center in Canada. A total of 40 participants were screened, of whom 39 were randomized for treatment and 1 withdrew consent prior to randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence A-B-C | Participants randomized to this group brushed their teeth as follows in supervision of study staff during site visit: Prototype PTB (A) in Period 1 (for 2 timed minutes [min] in 'Gumline' mode and 1 timed min in 'Interdental' mode) followed by Reference MTB (B) in Period 2 (for 1 timed min) and Reference PTB (C) in Period 3 (for 2 timed min). Clinical assessments were performed after 'Gumline' mode and 'Interdental' mode in same treatment period. Each treatment period was followed by a minimum of 3-days washout period and prior to each site visit, participants abstained from all oral hygiene for at least 12 hours. Participants received a fluoride toothpaste and manual toothbrush to use at home during washout period, recorded each brushing occasion (at home) and time of their last brushing prior to their next scheduled appointment on their diary. Overall study duration from first subject first visit (FSFV) to last subject last visit (LSLV) was 32 days. |
| FG001 | Sequence B-A-C | Participants randomized to this group brushed their teeth as follows in supervision of study staff during site visit: Reference MTB (B) in Period 1 (for 1 timed minute) followed by Prototype PTB (A) in Period 2 (for 2 timed minutes in 'Gumline' mode and 1 timed minute in 'Interdental' mode) and Reference PTB in Period 3 (C) (for 2 timed minutes). Clinical assessments were performed after 'Gumline' mode and after 'Interdental' mode in same treatment period. Each treatment period was followed by a minimum of 3-days washout period and prior to each site visit, participants abstained from all oral hygiene for at least 12 hours. Participants received a fluoride toothpaste and manual toothbrush to use at home during the washout period and recorded each brushing occasion (at home) and time of their last brushing prior to their next scheduled appointment on their diary. Overall study duration from FSFV to LSLV was 32 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (Visit 2) |
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| Washout Period 1 (3 Days) |
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| Period 2 (Visit 3) |
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| Washout Period 2 (3 Days) |
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| Period 3 (Visit 4) |
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Modified intent-to-treat (m-ITT) population included all participants who are randomized, received at least one of the study treatments and provide at least one post-brushing assessment of efficacy.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Treatment Combined | All randomized participants received treatment in either sequence A-B-C or sequence B-A-C. Participants in the product sequence A-B-C applied Prototype PTB (A) in Period 1 followed by Reference MTB (B) in Period 2 and Reference PTB (C) in Period 3, whereas, in product sequence B-A-C participants applied Reference MTB (B) in Period 1 followed by Prototype PTB (A) in Period 2 and Reference PTB (C) in Period 3. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 in Whole Mouth Rustogi Modified Navy Plaque Index (RMNPI) Score From Pre-Brushing to Post-Brushing (When Prototype Power Toothbrush [PTB] Was Used in 'Gumline' Mode vs a Reference Manual Toothbrush [MTB]) | Change in plaque removal efficacy from pre-brushing to post-brushing in whole mouth (sites A to I) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' mode versus a reference MTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score). | Modified Intent-to-Treat (mITT) Population included all randomized participants who had received at least one dose of study products (supervised brushing in study period 1, 2 or 3) and had provided at least one post-brushing assessment of efficacy. | Posted | Mean | Standard Deviation | Score on a scale | After 2 minutes of brushing |
37 Days
Safety population: all participants who were eligible to participate in the study and had participated in the Supervised PTB Training. 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 | Prototype PTB (A) | Participants randomized to receive Prototype PTB either in Treatment Period 1 or Treatment Period 2 for 2 timed minutes in 'Gumline' mode and 1 timed minute in 'Interdental' mode. Clinical assessments were performed after the 'Gumline' mode and after the 'Interdental' mode in same treatment period. |
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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 | Mar 28, 2019 | Aug 7, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 12, 2019 | Aug 7, 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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| Reference PTB | Device | Participants will brush their teeth with power toothbrush and 1.3 g ± 0.1 g of fluoride toothpaste (containing 0.76% w/w sodium monofluorophosphate) for 2-timed minute under supervision of study staff. |
|
| Prototype PTB (Gum line mode) | Device | Participants will brush their teeth with prototype PTB toothbrush and 1.3 g ± 0.1 g of fluoride toothpaste (containing 0.76% w/w sodium monofluorophosphate) for 2-timed minute in "Gum Line" mode under supervision of study staff. |
|
| Prototype PTB (Combined mode) | Device | Participants will brush their teeth with prototype PTB toothbrush and 1.3 g ± 0.1 g of fluoride toothpaste (containing 0.76% w/w sodium monofluorophosphate) for 2-timed minute in "Gum Line" mode and 1-timed minute in "Interdental" mode under supervision of study staff. |
|
| After 2 minutes of brushing |
| Change in Proximal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs a Reference MTB) | Change in plaque removal efficacy from pre-brushing to post-brushing at the proximal tooth areas (referred to as proximal score-sites D and F) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' mode versus a reference MTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score). | After 2 minutes of brushing |
| Change in Whole Mouth RMNPI Score From Pre-brushing to Post-brushing (When Prototype PTB Was Used in 'Combined' Mode vs a Reference MTB) | Change in plaque removal efficacy from pre-brushing to post-brushing in whole mouth (site A to I) was assessed using RMNPI score, when prototype PTB used in the 'Combined' Mode ('Gumline' mode followed by 'Interdental' mode) versus a reference MTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score). | After 3 minutes of brushing |
| Change in Marginal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Combined' Mode vs a Reference MTB) | Change in plaque removal efficacy from pre-brushing to post-brushing at the gum line (referred as marginal score-sites A to C) was assessed using RMNPI score, when prototype PTB used in the 'Combined' Mode ('Gumline' mode for 2 minutes followed by 'Interdental' mode for 1 minute) versus a reference MTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score). | After 3 minutes of brushing |
| Change in Proximal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Combined' Mode vs a Reference MTB) | Change in plaque removal efficacy from pre-brushing to post-brushing at the proximal tooth areas (referred to as proximal score-sites D and F) was assessed using RMNPI score, when prototype PTB used in the 'Combined' Mode ('Gumline' mode for 2 minutes followed by 'Interdental' mode for 1 minute) versus a reference MTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score). | After 3 minutes of brushing |
| Change in Whole Mouth RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs 'Combined' Mode) | Change in plaque removal efficacy from pre-brushing to post-brushing in whole mouth (site A to I) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' mode versus prototype PTB used in the 'Combined' Mode ('Gumline' mode for 2 minutes followed by 'Interdental' mode for 1 minute) after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score). | After 3 minutes of brushing |
| Change in Marginal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs 'Combined' Mode) | Change in plaque removal efficacy from pre-brushing to post-brushing at the gum line (referred as marginal score-sites A to C) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' mode versus prototype PTB used in the 'Combined' Mode ('Gumline' mode for 2 minutes followed by 'Interdental' mode for 1 minute) after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score). | After 3 minutes of brushing |
| Change in Proximal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs 'Combined' Mode) | Change in plaque removal efficacy from pre-brushing to post-brushing at the proximal tooth areas (referred to as proximal score-sites D and F) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' mode versus prototype PTB used in the 'Combined' Mode ('Gumline' mode for 2 minutes followed by 'Interdental' mode for 1 minute) after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assigned on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score). | After 3 minutes of brushing |
| Change in Whole Mouth RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' and 'Combined' Modes Versus a Reference PTB) | Change in plaque removal efficacy from pre-brushing to post-brushing in whole mouth (site A to I) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' and 'Combined' mode versus a reference PTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score). | After 3 minutes of brushing |
| Change in Marginal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' and 'Combined' Modes Versus a Reference PTB) | Change in plaque removal efficacy from pre-brushing to post-brushing at the gum line (referred as marginal score-sites A to C) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' and 'Combined' mode versus a reference PTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score). | After 3 minutes of brushing |
| Change in Proximal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' and 'Combined' Modes Versus a Reference PTB) | Change in plaque removal efficacy from pre-brushing to post-brushing at the proximal tooth areas (referred to as proximal score-sites D and F) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' and 'Combined' mode versus a reference PTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score). | After 3 minutes of brushing |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| ID | Title | Description |
|---|---|---|
| OG000 | Prototype PTB "Gumline" | Participants randomized to receive Prototype PTB either in Treatment Period 1 or Treatment Period 2 for 2 timed minutes in 'Gumline' mode. Clinical assessments were performed after the 'Gumline' mode. |
| OG001 | Reference MTB | Participants randomized to receive Reference MTB either in Treatment Period 1 or Treatment Period 2 for 1 timed minute. |
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| Secondary | Change in Marginal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs a Reference MTB) | Change in plaque removal efficacy from pre-brushing to post-brushing at the gum line (referred as marginal score-sites A to C) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' mode versus a reference MTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score). | mITT Population included all randomized participants who had received at least one dose of study products (supervised brushing in study period 1, 2 or 3) and had provided at least one post-brushing assessment of efficacy. | Posted | Mean | Standard Deviation | Score on a scale | After 2 minutes of brushing |
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| Secondary | Change in Proximal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs a Reference MTB) | Change in plaque removal efficacy from pre-brushing to post-brushing at the proximal tooth areas (referred to as proximal score-sites D and F) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' mode versus a reference MTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score). | mITT Population included all randomized participants who had received at least one dose of study products (supervised brushing in study period 1, 2 or 3) and had provided at least one post-brushing assessment of efficacy. | Posted | Mean | Standard Deviation | Score on a scale | After 2 minutes of brushing |
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| Secondary | Change in Whole Mouth RMNPI Score From Pre-brushing to Post-brushing (When Prototype PTB Was Used in 'Combined' Mode vs a Reference MTB) | Change in plaque removal efficacy from pre-brushing to post-brushing in whole mouth (site A to I) was assessed using RMNPI score, when prototype PTB used in the 'Combined' Mode ('Gumline' mode followed by 'Interdental' mode) versus a reference MTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score). | mITT Population included all randomized participants who had received at least one dose of study products (supervised brushing in study period 1, 2 or 3) and had provided at least one post-brushing assessment of efficacy. Here, number analyzed indicates participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | Score on a scale | After 3 minutes of brushing |
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| Secondary | Change in Marginal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Combined' Mode vs a Reference MTB) | Change in plaque removal efficacy from pre-brushing to post-brushing at the gum line (referred as marginal score-sites A to C) was assessed using RMNPI score, when prototype PTB used in the 'Combined' Mode ('Gumline' mode for 2 minutes followed by 'Interdental' mode for 1 minute) versus a reference MTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score). | mITT Population included all randomized participants who had received at least one dose of study products (supervised brushing in study period 1, 2 or 3) and had provided at least one post-brushing assessment of efficacy. Here, number analyzed indicates participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | Score on a scale | After 3 minutes of brushing |
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| Secondary | Change in Proximal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Combined' Mode vs a Reference MTB) | Change in plaque removal efficacy from pre-brushing to post-brushing at the proximal tooth areas (referred to as proximal score-sites D and F) was assessed using RMNPI score, when prototype PTB used in the 'Combined' Mode ('Gumline' mode for 2 minutes followed by 'Interdental' mode for 1 minute) versus a reference MTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score). | mITT Population included all randomized participants who had received at least one dose of study products (supervised brushing in study period 1, 2 or 3) and had provided at least one post-brushing assessment of efficacy. Here, number analyzed indicates participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | Score on a scale | After 3 minutes of brushing |
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| Secondary | Change in Whole Mouth RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs 'Combined' Mode) | Change in plaque removal efficacy from pre-brushing to post-brushing in whole mouth (site A to I) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' mode versus prototype PTB used in the 'Combined' Mode ('Gumline' mode for 2 minutes followed by 'Interdental' mode for 1 minute) after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score). | mITT Population included all randomized participants who had received at least one dose of study products (supervised brushing in study period 1, 2 or 3) and had provided at least one post-brushing assessment of efficacy. Here, number analyzed indicates participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | Score on a scale | After 3 minutes of brushing |
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| Secondary | Change in Marginal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs 'Combined' Mode) | Change in plaque removal efficacy from pre-brushing to post-brushing at the gum line (referred as marginal score-sites A to C) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' mode versus prototype PTB used in the 'Combined' Mode ('Gumline' mode for 2 minutes followed by 'Interdental' mode for 1 minute) after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score). | mITT Population included all randomized participants who had received at least one dose of study products (supervised brushing in study period 1, 2 or 3) and had provided at least one post-brushing assessment of efficacy. Here, number analyzed indicates participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | Score on a scale | After 3 minutes of brushing |
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| Secondary | Change in Proximal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs 'Combined' Mode) | Change in plaque removal efficacy from pre-brushing to post-brushing at the proximal tooth areas (referred to as proximal score-sites D and F) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' mode versus prototype PTB used in the 'Combined' Mode ('Gumline' mode for 2 minutes followed by 'Interdental' mode for 1 minute) after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assigned on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score). | mITT Population included all randomized participants who had received at least one dose of study products (supervised brushing in study period 1, 2 or 3) and had provided at least one post-brushing assessment of efficacy. Here, number analyzed indicates participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | Score on a scale | After 3 minutes of brushing |
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| Secondary | Change in Whole Mouth RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' and 'Combined' Modes Versus a Reference PTB) | Change in plaque removal efficacy from pre-brushing to post-brushing in whole mouth (site A to I) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' and 'Combined' mode versus a reference PTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score). | mITT Population included all randomized participants who had received at least one dose of study products (supervised brushing in study period 1, 2 or 3) and had provided at least one post-brushing assessment of efficacy. Here, number analyzed indicates participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | Score on a scale | After 3 minutes of brushing |
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| Secondary | Change in Marginal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' and 'Combined' Modes Versus a Reference PTB) | Change in plaque removal efficacy from pre-brushing to post-brushing at the gum line (referred as marginal score-sites A to C) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' and 'Combined' mode versus a reference PTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score). | mITT Population included all randomized participants who had received at least one dose of study products (supervised brushing in study period 1, 2 or 3) and had provided at least one post-brushing assessment of efficacy. Here, number analyzed indicates participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | Score on a scale | After 3 minutes of brushing |
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| Secondary | Change in Proximal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' and 'Combined' Modes Versus a Reference PTB) | Change in plaque removal efficacy from pre-brushing to post-brushing at the proximal tooth areas (referred to as proximal score-sites D and F) was assessed using RMNPI score, when prototype PTB used in the 'Gumline' and 'Combined' mode versus a reference PTB after a single brushing event. Dental plaque was assessed on all teeth excluding third molars (Universal Numbering System teeth 2 to 15, and 18 to 31), crowns, and surfaces with cervical restorations for a maximum of 28 eligible teeth. Plaque was assessed on one of the following score: 0 represents no dental plaque and 1 represents plaque present in the measured segment of the tooth; where lower score represents the better plaque removal efficacy. Change from pre-brushing = (post-brushing score - pre-brushing score). | mITT Population included all randomized participants who had received at least one dose of study products (supervised brushing in study period 1, 2 or 3) and had provided at least one post-brushing assessment of efficacy. Here, number analyzed indicates participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | Score on a scale | After 3 minutes of brushing |
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| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Reference MTB (B) | Participants randomized to receive Reference MTB either in Treatment Period 1 or Treatment Period 2 for 1 timed minute. | 0 | 40 | 0 | 40 | 0 | 40 |
| EG002 | Reference PTB (C) | Participants randomized to receive Reference PTB in Treatment Period 3 for 2 timed minute. | 0 | 40 | 0 | 40 | 0 | 40 |
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.
| ANCOVA |
| 0.0214 |
Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline. |
| Adjusted Mean Difference |
| -0.03 |
| Standard Error of the Mean |
| 0.014 |
| 2-Sided |
| 95 |
| -0.06 |
| -0.00 |
| Superiority |
| ANCOVA |
| 0.0010 |
Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline. |
| Adjusted Mean Difference |
| -0.09 |
| Standard Error of the Mean |
| 0.025 |
| 2-Sided |
| 95 |
| -0.14 |
| -0.04 |
| Superiority |
| ANCOVA |
| 0.1652 |
Analysis was performed using ANCOVA model with product, sequence as fixed effects, participant as a random effect and two baseline terms as covariates;1-participant-level baseline score,2-period level baseline minus the participant-level baseline. |
| Adjusted Mean Difference |
| -0.04 |
| Standard Error of the Mean |
| 0.026 |
| 2-Sided |
| 95 |
| -0.09 |
| 0.01 |
| Superiority |