CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 185 enrolled
Drug / intervention
0.454% Stannous fluoride (SnF2) and 0.072% sodium fluoride (NaF): 1450 ppm fluoride in total +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/NCT03310268
NCT03310268N/ACompleted
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A Randomized, 8 Week Clinical Study to Evaluate the Efficacy of an Experimental Stannous Fluoride Dentifrice in the Relief of Dentinal Hypersensitivity

GlaxoSmithKline·interventional·Posted Oct 16, 2017·Updated Nov 27, 2020

In Brief

A clinical study evaluating 0.454% Stannous fluoride (SnF2) and 0.072% sodium fluoride (NaF): 1450 ppm fluoride in total, 1400 ppm fluoride as sodium monofluorophosphate (SMFP), and 1 other intervention for Dentin Sensitivity. Completed, enrolled 185 participants across 1 site.

Detailed Summary

The purpose of this study is to provide evidence of clinical efficacy of an experimental dentifrice containing stannous fluoride (SnF2) compared to regular fluoride dentifrice in the reduction of dentinal hypersensitivity (DH). This study will be considered successful if there is a statistically significant difference in the primary efficacy variable, change from baseline in Schiff sensitivity score, after 8 weeks of treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDentin Sensitivity
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedOct 16, 2017
Enrollment StartNov 18, 2017
Primary CompletionFeb 2, 2018
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 8.7 years ago

Interventions

0.454% Stannous fluoride (SnF2) and 0.072% sodium fluoride (NaF): 1450 ppm fluoride in totalother

Participants will be instructed to apply experimental dentifrice (containing 454% SnF2 and 0.072% NaF, 1450 ppm fluoride in total), covering the full length of toothbrush head (full ribbon) and will brush twice daily (morning and evening) for one timed minute (in their usual manner) and expectorate.

1400 ppm fluoride as sodium monofluorophosphate (SMFP)other

Participants will be instructed to apply negative control dentifrice (containing 1400 ppm fluoride as SMFP), covering the full length of toothbrush head (full ribbon) and will brush twice daily (morning and evening) for one timed minute (in their usual manner) and expectorate.

Stannous Chloride (SnCl2) and 0.15% NaF: 1450 ppm fluoride in totalother

Participants will be instructed to apply positive control dentifrice (containing SnCl2 and 0.15% NaF, 1450 ppm fluoride in total), covering the full length of toothbrush head (full ribbon) and will brush twice daily (morning and evening) for one timed minute (in their usual manner) and expectorate.