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

Phase 3

Completed

• Conditions: Dentine Hypersensitivity
• Interventions: Drug: Stannous Fluoride; Drug: Sodium Monofluorophosphate

• Registration Number: NCT01592864
• Lead Sponsor: GlaxoSmithKline

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Study First Submitted: 2012-05-03
• Study First Submitted QC: 2012-05-03
• Study First Posted: 2012-05-07
• Results First Submitted: 2013-05-16
• Status Verified: 2013-12
• Results First Submitted QC: 2014-02-06
• Last Update Submitted: 2014-02-06
• Results First Posted: 2014-03-10
• Last Update Posted: 2014-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Subjects who suffer from tooth sensitivity

Inclusion Criteria:

• none

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Stannous Fluoride	Dentifrice containing stannous fluoride
Arm 2	Sodium Monofluorophosphate	Marketed dentifrice containing Sodium Monofluorophosphate

Primary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 8	Baseline to 8 weeks post administration of study treatment	Response to a constant jet of air applied to hypersensitive teeth is evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.

Secondary Outcome Measures

Name	Time	Method
Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 4	Baseline to 4 weeks post administration of study treatment	Response to a constant jet of air applied to hypersensitive teeth was evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 3; 0 - participant does not respond to air stimulation, 1 - participant responds to air stimulus but does not request discontinuation of stimulus, 2 - participant responds to air stimulus and request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus.
Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 8	Baseline to 8 weeks post administration of study treatment	Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. The constant pressure probe allowed the examiner to vary the force applied to the dentin surface from 10 grams (g) to an upper threshold of 80 g, in increments of 10g since the values below represents adjusted mean change in baseline, the value can fall below scale range. The greater the pressure the subject was able to tolerate, the less. Change from baseline in tactile response to Week 8 was calculated.; sensitive the tooth. According to this tactile sensitivity assessment, an increasing force was applied to hypersensitive tooth until a yes response is recorded or the maximum force has been reached.
Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 4	Baseline to 4 weeks post administration of study treatment	Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. The constant pressure probe allowed the examiner to vary the force applied to the dentin surface from 10g to an upper threshold of 80g, in increments of 10g. The greater the pressure the subject was able to tolerate, the less sensitive the tooth. According to this tactile sensitivity assessment, an increasing force was applied to hypersensitive tooth until a yes response is recorded or the maximum force has been reached. Change from baseline in tactile response to Week 4 was calculated

Trial Locations

Locations (1)

BioSci Research America, Inc.; 🇺🇸 Las Vegas, Nevada, United States