Phase 3 N=113 Randomized Single-blind Treatment

Clinical Efficacy of a Toothpaste in Providing Relief From the Pain of Dentinal Hypersensitivity

Dentine Hypersensitivity

Bottom Line

View on ClinicalTrials.gov: NCT01592851 ↗

Enrolled (actual)

113

Serious AEs

0.0%

Results posted

Jun 2014

Primary outcome: Primary: Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 14 — -1.20; -0.37 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 Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 14	-1.20; -0.37	<0.0001 sig
SECONDARY Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale Immediately Post-treatment	-0.40; -0.14	0.0006 sig
SECONDARY Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 3	-0.70; -0.25	<0.0001 sig
SECONDARY Change From Baseline in Tactile Pain Threshold Score at Day 14	22.9; 3.5	<0.0001 sig
SECONDARY Change From Baseline in Tactile Pain Threshold Score at Day 3	9.8; 3.0	0.0021 sig
SECONDARY Change From Baseline in Tactile Pain Threshold Score Immediately Post-treatment	5.8; 1.9	0.0070 sig

Summary

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

Eligibility Criteria

Subjects who suffer from tooth sensitivity.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01592851). 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.