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

• ClinicalTrials.gov Identifier: NCT01592864
• Recruitment Status: Completed
• First Posted: May 7, 2012
• Results First Posted: March 10, 2014
• Last Update Posted: March 10, 2014
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Study Description

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

• 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

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

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

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older 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

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

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT01592864
• 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:

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