NCT03285984

Ability of Four Toothpastes to Remove Plaque

Plaque Removal Efficacy of Four Dentifrices in a Single Brushing Model

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to evaluate and compare the plaque removal efficacy of four experimental toothpastes following a single timed brushing. Prior to each treatment visit, participants will abstain from oral hygiene for a period of 24 hours (+6hrs, -2hrs), immediately preceding a pre-brushing dental plaque evaluation. Participants will then brush once under supervision for one timed minute with each dentifrice after which re-disclosing and a post-brushing plaque assessment will be carried out.

Detailed description

This study will be a single centre, randomized, controlled, examiner blind, four treatment, four period crossover design. At the screening visit, following provision of written informed consent, eligible participants will be provided with a washout toothpaste and toothbrush for use at home during the study and for at least 14 days prior to the first treatment visit. Participants will then be scheduled to attend the first of four treatment visits a minimum of 14 days later. For each treatment visit, participants must abstain from oral hygiene for a period of 24 hours (+6hrs, -2hrs), immediately preceding the pre-brushing dental plaque evaluation. All the participants will undergo an oral soft tissue (OST) examination followed by disclosing and a dental plaque assessment. At the treatment visit 1 pre-brushing plaque assessment, those who develop a sufficient amount of plaque (Turesky mean score ≥ 2.00) will be randomized to study treatment. Participants will then brush once (1.5 grams \[g\] ± 0.05g of assigned toothpaste), under supervision of study staff for one timed minute, with one of the four test toothpastes after which re-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 commercial washout toothpaste. Participants will complete four treatment visits and will brush once with each of the four test toothpastes throughout the course of the study.

Conditions

• Dental Plaque

Interventions

Type	Name	Description
OTHER	67% Sodium Bicarbonate with 6 herbs plus 923parts per million (ppm) Sodium Fluoride	Toothpaste containing 67 percent (%) Sodium Bicarbonate with 6 herbs plus 923parts per million (ppm) Sodium Fluoride
OTHER	67% Sodium Bicarbonate without herbs plus 923 ppm Sodium Fluoride	Toothpaste containing 67% Sodium Bicarbonate without herbs plus 923 ppm Sodium Fluoride
OTHER	62% Sodium Bicarbonate with 6 herbs and 5% w/w silica plus 923 ppm Sodium	Whitening Toothpaste containing 62% Sodium Bicarbonate with 6 herbs and 5% w/w silica plus 923 ppm Sodium
OTHER	0% Sodium Bicarbonate without herbs plus 923ppm Sodium Fluoride	Toothpaste containing 0% Sodium Bicarbonate without herbs plus 923ppm Sodium Fluoride

Timeline

• Start date: 2012-03-27
• Primary completion: 2012-05-08
• Completion: 2012-05-08
• First posted: 2017-09-18
• Last updated: 2018-10-16
• Results posted: 2018-10-16