CompletedPhase 2

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

Canada110 participantsStarted 2021-02-10

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. Participant with at least 20 natural, permanent teeth.
✓. Participant with at least 40 evaluable surfaces for MGI, BI and TPI. An evaluable surface is defined as having 2/3rds of the natural tooth surface gradable for the selected clinical indices. The following should not be included in the evaluable surface count- third molars; fully crowned/extensively restored, grossly carious, orthodontically banded/bonded or abutment teeth; surfaces with calculus deposits which, in the opinion of the clinical examiner, would interfere with the baseline assessments of the selected clinical indices.
✓. Participant with generalized mild- moderate plaque-induced gingivitis, in the opinion of the clinical examiner, as confirmed by a gross visual examination at the Screening Visit.
✓. Participant with ongoing hard tissue eligibility and, in the opinion of the clinical examiner, at least 40 evaluable surfaces.
✓. Participant with mean whole mouth MGI between 1.75 and 2.30.
✓. Participant with mean whole mouth TPI score ≥1.5.
✓. Participant with a minimum of 20 bleeding sites.

Exclusion criteria

What they're measuring

Number of Bleeding Sites at 6 Weeks (Comparison of Experimental Versus Negative Control Dentifrice)

Timeframe: At Week 6

Trial details

NCT IDNCT04737538

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-07-28

Results submitted2022-07-19

View on ClinicalTrials.gov More Gingivitis trials