CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 98 enrolled
Drug / intervention
Stannous fluoride +1 moredrug
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/NCT04123665
NCT04123665Phase 3Completed

A Clinical Study Investigating the Gingivitis Efficacy of a Test Dentifrice

GlaxoSmithKline·interventional·Posted Oct 11, 2019·Updated Jan 31, 2020

In Brief

A Phase 3 clinical trial evaluating Stannous fluoride and Sodium monofluorophosphate for Gingivitis. Completed, enrolled 98 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate and compare the gingival health of a test dentifrice (0.454% weight by weight \[w/w\] stannous fluoride) to a negative control dentifrice by comparing modified gingival index, bleeding index and plaque index scores.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGingivitis
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 11, 2019
Enrollment StartMay 28, 2013
Primary CompletionDec 11, 2013
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 6.7 years ago

Interventions

Stannous fluoridedrug

In this arm, participants will apply a full ribbon of dentifrice ( 0.454% w/w stannous fluoride) to the bristles of a study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) and record on their study diary completed brushings.

Sodium monofluorophosphatedrug

In this arm, participants will apply a full ribbon of negative control dentifrice (1000 ppm fluoride as SMFP to the bristles of a study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) and record on their study diary completed brushings.