A Proof-of-principle Clinical Study Investigating the Efficacy of an Experimental Dentifrice Containing Sodium Bicarbonate and Sodium Hyaluronate on Gingivitis

Phase 2

Completed

Conditions: Gingivitis

Interventions: Other: Positive control dentifrice
Other: Negative control dentifrice
Other: Experimental Dentrifrice

Registration Number: NCT04737538

Lead Sponsor: GlaxoSmithKline

Brief Summary: The aim of this study is to develop a daily use toothpaste containing sodium bicarbonate, sodium hyaluronate and sodium fluoride with the intention of providing improved/ fast gum healing. This Proof-of-Principle study will investigate the efficacy of an experimental dentifrice compared to a regular fluoride dentifrice, and also whether this provides any additional benefit in reducing gingival inflammation/ bleeding compared with a 67% w/w sodium bicarbonate/ 0.221% w/w sodium fluoride containing toothpaste.

Detailed Description: This study will be a single-center, examiner-blind, randomized, stratified, three-treatment, parallel group study in healthy adult volunteers with mild to moderate gingivitis. There will be six visits to the study site: Screening, Baseline, Day 3 and Weeks 1, 2 and 6. Gingivitis will be assessed using a Modified Gingival Index (MGI) and a Bleeding Index (BI). Plaque will be assessed by the Turesky modification of the Quigley Hein (TPI). All evaluable teeth (in relation to the inclusion/ exclusion general dentition criteria) will be assessed.

The dosage regimen of twice daily treatment (morning and evening) for the washout dentifrice and study products will be the same for all participants and is based on widely recommended oral hygiene practice/typical consumer habit. Study participants will be instructed to brush for at least 1 timed minute with their assigned study dentifrice on each brushing occasion. After 6 weeks (Day 42+/-3 days) twice daily treatment, each participant should complete between approximately 84-90 treatment applications. During the washout period for this study (minimum 14 days/ maximum 28 days), eligible participants will use a marketed, regular fluoride toothpaste and toothbrush (as provided).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 110

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Positive control	Positive control dentifrice	Participants assigned to this arm will apply full ribbon of toothpaste (dentifrice containing 67% w/w sodium bicarbonate and 0.221% w/w sodium fluoride) to cover the head of toothbrush provided and will brush their teeth for one timed minute twice a day (morning and evening).
Negative control	Negative control dentifrice	Participants assigned to this arm will apply full ribbon of toothpaste (dentifrice containing 1100ppm fluoride as sodium fluoride \[Crest Cavity Protection\]) to cover the head of toothbrush provided and will brush their teeth for one timed minute twice a day (morning and evening).
Experimental Dentifrice	Experimental Dentrifrice	Participants assigned to this arm will apply full ribbon of toothpaste (containing sodium bicarbonate, sodium hyaluronate and sodium fluoride) to cover the head of toothbrush provided and will brush their teeth for one timed minute twice a day (morning and evening).

Primary Outcome Measures

Name	Time	Method
Number of Bleeding Sites at 6 Weeks (Comparison of Experimental Versus Negative Control Dentifrice)	At Week 6	Number of bleeding sites were assessed by examiner by gently inserting a probe into the gingival crevice to a depth of approximately 1 millimeter (mm) and then running around the tooth (at an angle of approximately 60 degree to the long axis of the tooth), gently stretching the epithelium while sweeping from interproximal to interproximal along the sulcular epithelium. Gingival bleeding sites were assessed 30 seconds after probing. Analysis was performed using Analysis of Covariance (ANCOVA) model with study product group and gender as factors and baseline number of bleeding sites as covariate. The estimates were based on separate ANCOVA model using only the data for corresponding comparison (experimental dentifrice vs negative control dentifrice).

Secondary Outcome Measures

Name	Time	Method
Number of Bleeding Sites at Week 6 (Comparison of Experimental Versus Positive Control Dentifrice)	At Week 6	Number of bleeding sites were assessed by examiner by gently inserting a probe into the gingival crevice to a depth of approximately 1 mm and then running around the tooth (at an angle of approximately 60 degree to the long axis of the tooth), gently stretching the epithelium while sweeping from interproximal to interproximal along the sulcular epithelium. Gingival bleeding sites were assessed 30 seconds after probing. Analysis was performed using ANCOVA model with study product group and gender as factors and baseline number of bleeding sites as covariate. The estimates were based on separate ANCOVA model using only the data for corresponding comparison (experimental dentifrice vs positive control dentifrice).
Number of Bleeding Sites at Week 6 (Comparison of Positive Versus Negative Control Dentifrice)	At Week 6	Number of bleeding sites were assessed by examiner by gently inserting a probe into the gingival crevice to a depth of approximately 1 mm and then running around the tooth (at an angle of approximately 60 degree to the long axis of the tooth), gently stretching the epithelium while sweeping from interproximal to interproximal along the sulcular epithelium. Gingival bleeding sites were assessed 30 seconds after probing. Analysis was performed using ANCOVA model with study product group and gender as factors and baseline number of bleeding sites as covariate. The estimates were based on separate ANCOVA model using only the data for corresponding comparison (positive control dentifrice vs negative control dentifrice).