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

Summary

Participation Requirements

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 usi...

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).

Tracking Information