CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 135 enrolled
Drug / intervention
Stannous fluoride (SnF2) +1 moreother
Likely dose
Stannous fluoride (SnF2) 0.454% w/w with 0.072% w/w NaF dentifrice; or Sodium monofluorophosphate dentifrice containing 1400 ppm fluorideAI-extracted
Key inclusion· 5
  • Age 18-65 years inclusive
  • Self-reported history of dentinal hypersensitivity lasting more than six months but not more than 10 years
  • Good general oral health with a minimum of 20 natural teeth
  • Minimum of 2 accessible non-adjacent teeth (incisors, canines, or pre-molars) with signs of facial/cervical gingival recession and/or signs of erosion or abrasion, no clinically significant gingival inflammation, tooth mobility ≤1, and sensitivity on evaporative air assessment (Schiff sensitivity score ≥1) at Screening
Key exclusion· 15
  • Pregnant, intending to become pregnant during the study, or breastfeeding
  • Known or suspected intolerance or hypersensitivity to study materials or ingredients
  • Participation in another clinical study within 30 days of screening, previous participation in this study, or participation in another tooth desensitizing treatment study within 8 weeks of screening
  • Recent history (within the last year) of alcohol or other substance abuse

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

Search/NCT02861664
NCT02861664N/ACompleted

A Study to Evaluate the Efficacy of an Experimental Occlusion Technology Dentifrice in the Relief of Dentinal Hypersensitivity

GlaxoSmithKline·interventional·Posted Aug 10, 2016·Updated Aug 10, 2018

In Brief

A clinical study evaluating Stannous fluoride (SnF2) and Sodium monofluorophosphate (SMFP) for Dentin Sensitivity. Completed, enrolled 135 participants across 1 site.

Detailed Summary

This study will evaluate the effectiveness of an experimental dentifrice containing stannous fluoride, an established dentine tubule occlusion technology, at reducing dentine hypersensitivity (DH) compared to a negative control dentifrice. The test and control dentifrices will be administered for a total of 8 weeks, with assessments (via evaporative air and tactile stimuli) at baseline, and after 4 and 8 weeks twice-daily use.

Study Details

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

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedAug 10, 2016
Enrollment StartSep 21, 2016
Primary CompletionDec 1, 2016
Study CompletionDec 24, 2016
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 9.9 years ago

Interventions

Stannous fluoride (SnF2)other

Dentifrice containing 0.454% weight by weight (w/w) SnF2 and 0.072% w/w NaF

Sodium monofluorophosphate (SMFP)other

Dentifrice containing 1400 ppm fluoride as SMFP