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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01592851
First received: May 3, 2012
Last updated: May 1, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention Phase
Dentine Hypersensitivity
Drug: Stannous Fluoride
Drug: Sodium Monofluorophosphate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Clinical Study Investigating the Efficacy of a Dentifrice in Providing Short Term Relief From Dentinal Hypersensitivity

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 14 [ Time Frame: Baseline to Day 14 ] [ Designated as safety issue: No ]
    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. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and Day 14. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline.


Secondary Outcome Measures:
  • Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale Immediately Post-treatment [ Time Frame: Baseline to immediately post treatment administration ] [ Designated as safety issue: No ]
    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. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and immediately after treatment. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline.

  • Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 3 [ Time Frame: Baseline to Day 3 ] [ Designated as safety issue: No ]
    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. Those teeth that met the tactile threshold inclusion criterion (tactile threshold ≤ 20g) were assessed at baseline and Day 3. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline.

  • Change From Baseline in Tactile Pain Threshold Score at Day 14 [ Time Frame: Baseline to Day 14 ] [ Designated as safety issue: No ]
    The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a "yes" response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity

  • Change From Baseline in Tactile Pain Threshold Score at Day 3 [ Time Frame: Baseline to Day 3 ] [ Designated as safety issue: No ]
    The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a "yes" response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity.

  • Change From Baseline in Tactile Pain Threshold Score Immediately Post-treatment [ Time Frame: Baseline to immediately post treatment administration ] [ Designated as safety issue: No ]
    The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a "yes" response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity.


Enrollment: 113
Study Start Date: April 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Dentifrice containing stannous fluoride
Drug: Stannous Fluoride
dentifrice containing stannous fluoride
Active Comparator: Arm 2
Marketed dentifrice containing Sodium Monofluorophosphate
Drug: Sodium Monofluorophosphate
dentifrice containing Sodium Monofluorophosphate

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

- Subjects who suffer from tooth sensitivity.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01592851

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01592851     History of Changes
Other Study ID Numbers: RH01324
Study First Received: May 3, 2012
Results First Received: April 5, 2013
Last Updated: May 1, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dentin Sensitivity
Hypersensitivity
Tooth Diseases
Stomatognathic Diseases
Immune System Diseases
Fluorides
Tin Fluorides
Fluorophosphate
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014