CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 110 enrolled
Drug / intervention
Experimental Dentrifrice +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04737538
NCT04737538Phase 2Completed

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

GlaxoSmithKline·interventional·Posted Feb 4, 2021·Updated Jan 19, 2024

In Brief

A Phase 2 clinical trial evaluating Experimental Dentrifrice, Positive control dentifrice, and 1 other intervention for Gingivitis. Completed, enrolled 110 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGingivitis
CountriesCanada
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedFeb 4, 2021
Enrollment StartFeb 10, 2021
Primary CompletionJul 28, 2021
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 5.4 years ago

Interventions

Experimental Dentrifriceother

Toothpaste containing sodium bicarbonate, sodium hyaluronate and sodium fluoride

Positive control dentifriceother

Dentifrice containing 67% w/w sodium bicarbonate and 0.221% w/w sodium fluoride

Negative control dentifriceother

Dentifrice containing 1100ppm fluoride as sodium fluoride (Crest Cavity Protection)