Trial Outcomes & Findings for Dental Plaque Removal Ability of Prototype Power Toothbrush Versus a Manual Toothbrush in Healthy Participants (NCT NCT03809910)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

After 2 minutes of brushing

Results posted on

2020-09-16

Participant Flow

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.

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

Participant milestones

Participant milestones
Measure	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.	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.
Period 1 (Visit 2) STARTED	20	19
Period 1 (Visit 2) COMPLETED	20	19
Period 1 (Visit 2) NOT COMPLETED	0	0
Washout Period 1 (3 Days) STARTED	20	19
Washout Period 1 (3 Days) COMPLETED	20	19
Washout Period 1 (3 Days) NOT COMPLETED	0	0
Period 2 (Visit 3) STARTED	20	19
Period 2 (Visit 3) COMPLETED	20	19
Period 2 (Visit 3) NOT COMPLETED	0	0
Washout Period 2 (3 Days) STARTED	20	19
Washout Period 2 (3 Days) COMPLETED	20	19
Washout Period 2 (3 Days) NOT COMPLETED	0	0
Period 3 (Visit 4) STARTED	20	19
Period 3 (Visit 4) COMPLETED	20	19
Period 3 (Visit 4) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dental Plaque Removal Ability of Prototype Power Toothbrush Versus a Manual Toothbrush in Healthy Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Treatment Combined n=39 Participants 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.
Age, Continuous	42.2 Years STANDARD_DEVIATION 14.75 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	13 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: After 2 minutes of brushing

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Prototype PTB "Gumline" n=39 Participants 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.	Reference MTB n=39 Participants Participants randomized to receive Reference MTB either in Treatment Period 1 or Treatment Period 2 for 1 timed minute.	Reference PTB Participants randomized to receive Reference PTB in Treatment Period 3 for 2 timed minute.
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])	-0.38 Score on a scale Standard Deviation 0.086	-0.32 Score on a scale Standard Deviation 0.083	—

SECONDARY outcome

Timeframe: After 2 minutes of brushing

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Prototype PTB "Gumline" n=39 Participants 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.	Reference MTB n=39 Participants Participants randomized to receive Reference MTB either in Treatment Period 1 or Treatment Period 2 for 1 timed minute.	Reference PTB Participants randomized to receive Reference PTB in Treatment Period 3 for 2 timed minute.
Change in Marginal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs a Reference MTB)	-0.50 Score on a scale Standard Deviation 0.156	-0.38 Score on a scale Standard Deviation 0.166	—

SECONDARY outcome

Timeframe: After 2 minutes of brushing

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Prototype PTB "Gumline" n=39 Participants 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.	Reference MTB n=39 Participants Participants randomized to receive Reference MTB either in Treatment Period 1 or Treatment Period 2 for 1 timed minute.	Reference PTB Participants randomized to receive Reference PTB in Treatment Period 3 for 2 timed minute.
Change in Proximal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs a Reference MTB)	-0.66 Score on a scale Standard Deviation 0.175	-0.55 Score on a scale Standard Deviation 0.140	—

SECONDARY outcome

Timeframe: After 3 minutes of brushing

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Prototype PTB "Gumline" n=39 Participants 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.	Reference MTB n=39 Participants Participants randomized to receive Reference MTB either in Treatment Period 1 or Treatment Period 2 for 1 timed minute.	Reference PTB Participants randomized to receive Reference PTB in Treatment Period 3 for 2 timed minute.
Change in Whole Mouth RMNPI Score From Pre-brushing to Post-brushing (When Prototype PTB Was Used in 'Combined' Mode vs a Reference MTB)	-0.54 Score on a scale Standard Deviation 0.054	-0.32 Score on a scale Standard Deviation 0.083	—

SECONDARY outcome

Timeframe: After 3 minutes of brushing

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Prototype PTB "Gumline" n=39 Participants 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.	Reference MTB n=39 Participants Participants randomized to receive Reference MTB either in Treatment Period 1 or Treatment Period 2 for 1 timed minute.	Reference PTB Participants randomized to receive Reference PTB in Treatment Period 3 for 2 timed minute.
Change in Marginal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Combined' Mode vs a Reference MTB)	-0.76 Score on a scale Standard Deviation 0.141	-0.38 Score on a scale Standard Deviation 0.166	—

SECONDARY outcome

Timeframe: After 3 minutes of brushing

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Prototype PTB "Gumline" n=39 Participants 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.	Reference MTB n=39 Participants Participants randomized to receive Reference MTB either in Treatment Period 1 or Treatment Period 2 for 1 timed minute.	Reference PTB Participants randomized to receive Reference PTB in Treatment Period 3 for 2 timed minute.
Change in Proximal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Combined' Mode vs a Reference MTB)	-0.90 Score on a scale Standard Deviation 0.106	-0.55 Score on a scale Standard Deviation 0.140	—

SECONDARY outcome

Timeframe: After 3 minutes of brushing

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Prototype PTB "Gumline" n=39 Participants 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.	Reference MTB n=39 Participants Participants randomized to receive Reference MTB either in Treatment Period 1 or Treatment Period 2 for 1 timed minute.	Reference PTB Participants randomized to receive Reference PTB in Treatment Period 3 for 2 timed minute.
Change in Whole Mouth RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs 'Combined' Mode)	-0.38 Score on a scale Standard Deviation 0.086	-0.54 Score on a scale Standard Deviation 0.054	—

SECONDARY outcome

Timeframe: After 3 minutes of brushing

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Prototype PTB "Gumline" n=39 Participants 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.	Reference MTB n=39 Participants Participants randomized to receive Reference MTB either in Treatment Period 1 or Treatment Period 2 for 1 timed minute.	Reference PTB Participants randomized to receive Reference PTB in Treatment Period 3 for 2 timed minute.
Change in Marginal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs 'Combined' Mode)	-0.50 Score on a scale Standard Deviation 0.156	-0.76 Score on a scale Standard Deviation 0.141	—

SECONDARY outcome

Timeframe: After 3 minutes of brushing

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Prototype PTB "Gumline" n=39 Participants 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.	Reference MTB n=39 Participants Participants randomized to receive Reference MTB either in Treatment Period 1 or Treatment Period 2 for 1 timed minute.	Reference PTB Participants randomized to receive Reference PTB in Treatment Period 3 for 2 timed minute.
Change in Proximal RMNPI Score From Pre-Brushing to Post-Brushing (When Prototype PTB Was Used in 'Gumline' Mode vs 'Combined' Mode)	-0.66 Score on a scale Standard Deviation 0.175	-0.90 Score on a scale Standard Deviation 0.106	—

SECONDARY outcome

Timeframe: After 3 minutes of brushing

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Prototype PTB "Gumline" n=39 Participants 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.	Reference MTB n=39 Participants Participants randomized to receive Reference MTB either in Treatment Period 1 or Treatment Period 2 for 1 timed minute.	Reference PTB n=39 Participants Participants randomized to receive Reference PTB in Treatment Period 3 for 2 timed minute.
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)	-0.38 Score on a scale Standard Deviation 0.086	-0.54 Score on a scale Standard Deviation 0.054	-0.50 Score on a scale Standard Deviation 0.061

SECONDARY outcome

Timeframe: After 3 minutes of brushing

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Prototype PTB "Gumline" n=39 Participants 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.	Reference MTB n=39 Participants Participants randomized to receive Reference MTB either in Treatment Period 1 or Treatment Period 2 for 1 timed minute.	Reference PTB n=39 Participants Participants randomized to receive Reference PTB in Treatment Period 3 for 2 timed minute.
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)	-0.50 Score on a scale Standard Deviation 0.156	-0.76 Score on a scale Standard Deviation 0.141	-0.67 Score on a scale Standard Deviation 0.102

SECONDARY outcome

Timeframe: After 3 minutes of brushing

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Prototype PTB "Gumline" n=39 Participants 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.	Reference MTB n=39 Participants Participants randomized to receive Reference MTB either in Treatment Period 1 or Treatment Period 2 for 1 timed minute.	Reference PTB n=39 Participants Participants randomized to receive Reference PTB in Treatment Period 3 for 2 timed minute.
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)	-0.66 Score on a scale Standard Deviation 0.175	-0.90 Score on a scale Standard Deviation 0.106	-0.86 Score on a scale Standard Deviation 0.095

Adverse Events

Prototype PTB (A)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Reference MTB (B)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Reference PTB (C)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER