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

Gingivitis Clinical Trial

Official title:
A Randomized Controlled Examiner-blind Phase ii Proof-of-principle Clinical Study Investigating the Efficacy of an Experimental Dentifrice Containing Sodium Bicarbonate, High Molecular Weight Sodium Hyaluronate and Sodium Fluoride on Gingivitis and Plaque Removal in a Population With Mild-moderate Plaque-induced Gingivitis

Status Completed

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Gingivitis

Clinical Trial Details

NCT number	NCT04737538
Study type	Interventional
Source	GlaxoSmithKline
Contact
Status	Completed
Phase	Phase 2
Start date	February 10, 2021
Completion date	July 28, 2021

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.