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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Dentine Hypersensitivity	Drug: Stannous Fluoride; Drug: Sodium Monofluorophosphate	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	120 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Investigator)
Primary Purpose:	Treatment
Official Title:	A Clinical Study Investigating the Efficacy of a Dentifrice in Providing Long Term Relief From Dentinal Hypersensitivity
Study Start Date :	March 2012
Actual Primary Completion Date :	May 2012
Actual Study Completion Date :	May 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Arm 1; Dentifrice containing stannous fluoride	Drug: Stannous Fluoride; dentifice
Active Comparator: Arm 2; Marketed dentifrice containing Sodium Monofluorophosphate	Drug: Sodium Monofluorophosphate; dentifrice

Outcome Measures

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Primary Outcome Measures :

1. Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 8 [ Time Frame: 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 :

1. Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 4 [ Time Frame: 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.
2. Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 8 [ Time Frame: 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.

3. Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 4 [ Time Frame: 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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• Subjects who suffer from tooth sensitivity

Inclusion Criteria:

- none

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Nevada
BioSci Research America, Inc.
Las Vegas, Nevada, United States, 89121

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01592864 History of Changes
Other Study ID Numbers:	RH01325
First Posted:	May 7, 2012
Results First Posted:	March 10, 2014
Last Update Posted:	March 10, 2014
Last Verified:	December 2013

Additional relevant MeSH terms:

Hypersensitivity; Dentin Sensitivity; Immune System Diseases; Tooth Diseases; Stomatognathic Diseases; Fluorides	Tin Fluorides; Fluorophosphate; Cariostatic Agents; Protective Agents; Physiological Effects of Drugs