Trial Outcomes & Findings for Ability of Four Toothpastes to Remove Plaque (NCT NCT03285984)

Last Updated: 2018-10-16

Results Overview

The dental examiner used Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth.Overall plaque scores were calculated taking average over all tooth sites for participant.Plaque was first disclosed using dye solution followed by disclosing solution.They expectorated and rinsed with 10 milliliters (mL) water for 10 seconds (sec),expectorated again. Plaque was assessed with each tooth being divided into 6 areas including mesiofacial,facial,distofacial,mesiolingual,lingual,distolingual surfaces.Disclosed plaque was scored for each tooth surface separately as:0 No plaque;1 Slight flecks of plaque at cervical margin of the tooth;2 A thin continuous band of plaque(1 mm or smaller) at cervical margin of tooth;3 A band of plaque wider than 1 mm but covering less than 1/3 of the crown of tooth;4 Plaque covering at least 1/3 but less than 2/3 of crown of tooth;5 Plaque covering 2/3 or more of crown of tooth.Score range 0-5.Lower scores indicate less plaque area.

Recruitment status

COMPLETED

Study phase

Target enrollment

56 participants

Primary outcome timeframe

Baseline to 4 Weeks

Results posted on

2018-10-16

Participant Flow

Participants were recruited at a single center in the United States.

A Total of 56 participants were screened and randomized in the study. All 56 participants completed the study.

Participant milestones

Participant milestones
Measure	Overall Study This was a single centre, randomized, controlled, examiner blind, four treatment, four period crossover design study. Each Participant received Test product 1 (Toothpaste containing 67 percent \[%\] sodium bicarbonate with 6 herbs plus 923 parts per million \[ppm\] sodium fluoride, Test product 2 (Toothpaste containing 67% sodium bicarbonate without herbs plus 923ppm sodium fluoride), Test product 3 (Whitening Toothpaste containing 62% Sodium Bicarbonate with 6 herbs and 5% weight by weight \[w/w\] silica plus 923ppm Sodium), and Test product 4 (Toothpaste containing 0% Sodium Bicarbonate without herbs plus 923ppm sodium fluoride).
Overall Study STARTED	56
Overall Study Received Test Product 1	56
Overall Study Received Test Product 2	56
Overall Study Received Test Product 3	56
Overall Study Received Test Product 4	56
Overall Study COMPLETED	56
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ability of Four Toothpastes to Remove Plaque

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Randomized Participants n=56 Participants All randomized participants were included for baseline evaluation.
Age, Continuous	44.1 Years STANDARD_DEVIATION 11.87 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	5 Participants n=5 Participants
Race (NIH/OMB) White	51 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 4 Weeks

Population: ITT (Intent-to-treat) population was the primary analysis population, which included all the participants who were randomized and had at least one post-baseline efficacy evaluation.

Outcome measures

Outcome measures
Measure	Test Product 1 n=56 Participants Participants brushed once (1.5g ± 0.05g of toothpaste containing 67 % sodium bicarbonate with 6 herbs plus 923 ppm sodium fluoride), under supervision of study staff for one timed minute.	Test Product 4 n=56 Participants Participants brushed once (1.5g ± 0.05g of toothpaste containing 0% Sodium Bicarbonate without herbs plus 923ppm sodium fluoride), under supervision of study staff for one timed minute.	Test Product 3 Participants brushed once (1.5g ± 0.05g of whitening toothpaste containing 62% Sodium Bicarbonate with 6 herbs and 5% w/w silica plus 923ppm Sodium), under supervision of study staff for one timed minute.	Test Product 4 Participants brushed once (1.5g ± 0.05g of toothpaste containing 0% Sodium Bicarbonate without herbs plus 923ppm sodium fluoride), under supervision of study staff for one timed minute.
Mean Change From Baseline (Pre-brushing to Post-brushing) in Turesky Score After Single Supervised Use (Test Product 1 Versus [vs] Test Product 4) After 4 Weeks Baseline	2.90 Score on a scale Standard Deviation 0.308	2.86 Score on a scale Standard Deviation 0.309	—	—
Mean Change From Baseline (Pre-brushing to Post-brushing) in Turesky Score After Single Supervised Use (Test Product 1 Versus [vs] Test Product 4) After 4 Weeks Post Baseline	1.76 Score on a scale Standard Deviation 0.514	1.96 Score on a scale Standard Deviation 0.470	—	—
Mean Change From Baseline (Pre-brushing to Post-brushing) in Turesky Score After Single Supervised Use (Test Product 1 Versus [vs] Test Product 4) After 4 Weeks Change from Baseline	-1.13 Score on a scale Standard Deviation 0.430	-0.90 Score on a scale Standard Deviation 0.409	—	—

SECONDARY outcome

Timeframe: Baseline to 4 Weeks

Population: ITT (Intent-to-treat) population was the primary analysis population, which included all the participants who were randomized and had at least one post-baseline efficacy evaluation.

The dental examiner used Turesky Modification of the Quigley Hein Index to assess plaque on all gradable teeth.Overall plaque scores were calculated taking average over all tooth sites for participant.Plaque was first disclosed using dye solution followed by disclosing solution.They expectorated and rinsed with 10 mL of water for 10 sec,expectorated again. Plaque was assessed with each tooth being divided into 6 areas including mesiofacial,facial,distofacial,mesiolingual,lingual,distolingual surfaces.Disclosed plaque was scored for each tooth surface separately as:0 No plaque;1 Slight flecks of plaque at cervical margin of the tooth;2 A thin continuous band of plaque(1 mm or smaller) at cervical margin of tooth;3 A band of plaque wider than 1 mm but covering less than 1/3 of the crown of tooth;4 Plaque covering at least 1/3 but less than 2/3 of crown of tooth;5 Plaque covering 2/3 or more of crown of tooth.Score range 0-5.Lower scores indicate less plaque area.

Outcome measures

Outcome measures
Measure	Test Product 1 n=56 Participants Participants brushed once (1.5g ± 0.05g of toothpaste containing 67 % sodium bicarbonate with 6 herbs plus 923 ppm sodium fluoride), under supervision of study staff for one timed minute.	Test Product 4 n=56 Participants Participants brushed once (1.5g ± 0.05g of toothpaste containing 0% Sodium Bicarbonate without herbs plus 923ppm sodium fluoride), under supervision of study staff for one timed minute.	Test Product 3 n=56 Participants Participants brushed once (1.5g ± 0.05g of whitening toothpaste containing 62% Sodium Bicarbonate with 6 herbs and 5% w/w silica plus 923ppm Sodium), under supervision of study staff for one timed minute.	Test Product 4 n=56 Participants Participants brushed once (1.5g ± 0.05g of toothpaste containing 0% Sodium Bicarbonate without herbs plus 923ppm sodium fluoride), under supervision of study staff for one timed minute.
Mean Change From Baseline (Pre-brushing to Post Brushing) in Turesky Score After Single Supervised Use for Test Products 1, 2, 3 and 4 After 4 Weeks Baseline	2.90 Score on a scale Standard Deviation 0.308	2.92 Score on a scale Standard Deviation 0.312	2.89 Score on a scale Standard Deviation 0.304	2.86 Score on a scale Standard Deviation 0.309
Mean Change From Baseline (Pre-brushing to Post Brushing) in Turesky Score After Single Supervised Use for Test Products 1, 2, 3 and 4 After 4 Weeks Post Baseline	1.76 Score on a scale Standard Deviation 0.514	1.78 Score on a scale Standard Deviation 0.492	1.77 Score on a scale Standard Deviation 0.469	1.96 Score on a scale Standard Deviation 0.470
Mean Change From Baseline (Pre-brushing to Post Brushing) in Turesky Score After Single Supervised Use for Test Products 1, 2, 3 and 4 After 4 Weeks Change from Baseline after 4 weeks	-1.13 Score on a scale Standard Deviation 0.430	-1.14 Score on a scale Standard Deviation 0.426	-1.11 Score on a scale Standard Deviation 0.419	-0.90 Score on a scale Standard Deviation 0.409

Adverse Events

Test Product 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Test Product 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Test Product 3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Test Product 4

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