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Fluoride-containing Dentifrice

Experimental: stannous fluoride for Tooth Sensitivity

Phase 3
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, after single use (after 5 minutes) and on day 3
Awards & highlights

Summary

This single center, comparative design study will be used to investigate the efficacy of an experimental stannous fluoride containing dentifrice in relieving dentinal hypersensitivity (DH) after short term use compared with a standard fluoride dentifrice.

Eligible Conditions
  • Tooth Sensitivity

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, after single use (after 5 minutes)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, after single use (after 5 minutes) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in Schiff Sensitivity Score on Day 3
Secondary study objectives
Change From Baseline in Schiff Sensitivity Score After Single Use
Change From Baseline in Tactile Threshold Immediately After Single Use and on Day 3

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental: stannous fluorideExperimental Treatment1 Intervention
Participants will be instructed to dose a dry toothbrush containing 0.454% w/w of stannous fluoride (1000 parts per million \[ppm\] fluoride) with a full strip (1 inch) of toothpaste. Participants will then brush each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute.
Group II: Standard: sodium monofluorophosphateActive Control1 Intervention
Participants will be instructed to dose a dry toothbrush containing 0.76% w/w sodium monofluorophosphate (1000ppm fluoride) with a full strip (1 inch) of toothpaste. Participants will then brush each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stannous fluoride
FDA approved

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,792 Previous Clinical Trials
8,176,530 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,602 Previous Clinical Trials
6,144,626 Total Patients Enrolled
~25 spots leftby Sep 2025
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