CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 26 enrolled
Drug / intervention
Stannous fluoride +2 moredevice
Likely dose
Stannous fluoride 0.454% dentifrice or sodium monofluorophosphate 0.76% dentifriceAI-extracted
Key inclusion· 4
  • Aged between 18 and 80 years
  • Demonstrates understanding and willingness to participate with written informed consent
  • Able to accommodate lower bilateral buccal intra-oral appliances with four dentine samples
  • Good general and mental health with no clinically significant abnormalities in medical history or oral examination
Key exclusion· 7
  • Pregnant or intending to become pregnant during the study
  • Breast-feeding
  • Current or recurrent dental pathology that could affect study outcomes, including severe gingivitis, carious lesions, periodontal disease, or severe dental erosion
  • Known or suspected intolerance or hypersensitivity to study materials or their ingredients

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

Search/NCT02768194
NCT02768194N/ACompleted

Assessment of Dentine Tubule Occlusion in a Modified in Situ Model

GlaxoSmithKline·interventional·Posted May 11, 2016·Updated Jun 25, 2018

In Brief

A clinical study evaluating Stannous fluoride, Sodium monofluorophosphate, and 1 other intervention for Dentin Sensitivity. Completed, enrolled 26 participants across 1 site.

Detailed Summary

This will be a single centre, single blind, randomized, three treatment, three period crossover design, modified, in situ, study in healthy participants. In this in situ model the tubule occlusion properties of dentifrices will be evaluated by comparing an experimental dentifrice formulation to a regular fluoride dentifrice and a negative control (mineral water) over a ten day period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMay 11, 2016
Enrollment StartJul 6, 2016
Primary CompletionSep 1, 2016
Study CompletionSep 21, 2016
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 10.1 years ago

Interventions

Stannous fluoridedevice

Dentifrice containing 0.454% stannous fluoride

Sodium monofluorophosphateother

Dentifrice containing 0.76% sodium monofluorophosphate

Mineral waterother

Commercially available mineral water