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

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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:
Information provided by (Responsible Party):
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.

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

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
U.S. FDA Resources

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



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



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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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01592864


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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01592864     History of Changes
Other Study ID Numbers: RH01325
First Posted: May 7, 2012    Key Record Dates
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