Phase 3 N=118 Randomized Single-blind Treatment

The Efficacy of a Dentifrice in Providing Relief From the Pain of Dentinal Hypersensitivity

Dentine Hypersensitivity

Bottom Line

View on ClinicalTrials.gov: NCT01592864 ↗

Enrolled (actual)

118

Serious AEs

0.9%

Results posted

Mar 2014

Primary outcome: Primary: Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 8 — -0.9; -0.5 Score on a scale — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Stannous Fluoride (Drug); Sodium Monofluorophosphate (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: May 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 8	-0.9; -0.5	<0.0001 sig
SECONDARY Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 4	-0.7; -0.2	<0.0001 sig
SECONDARY Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 8	21.3; 4.2	<0.0001 sig
SECONDARY Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 4	11.2; 1.5	<0.0001 sig

Summary

A study to compare the efficacy of a test dentifrice against a control dentifrice in reducing dentinal hypersensitivity over an eight week treatment period.

Eligibility Criteria

Inclusion Criteria

Subjects who suffer from tooth sensitivity

Inclusion Criteria

none

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01592864). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.