Back to resultsClinical Efficacy of a Toothpaste in Providing Relief From the Pain of Dentinal Hypersensitivity
Primary Purpose
Dentine Hypersensitivity
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Stannous Fluoride
Sodium Monofluorophosphate
Sponsored by
About this trial
This is an interventional treatment trial for Dentine Hypersensitivity
Eligibility Criteria
- Subjects who suffer from tooth sensitivity.
Sites / Locations
- BioSci Research America, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm 1
Arm 2
Arm Description
Dentifrice containing stannous fluoride
Marketed dentifrice containing Sodium Monofluorophosphate
Outcomes
Primary Outcome Measures
Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 14
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
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
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
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01592851
Brief Title
Clinical Efficacy of a Toothpaste in Providing Relief From the Pain of Dentinal Hypersensitivity
Official Title
A Clinical Study Investigating the Efficacy of a Dentifrice in Providing Short Term Relief From Dentinal Hypersensitivity
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A study to compare the efficacy of a test dentifrice against a control dentifrice in reducing dentinal hypersensitivity over a two week treatment period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentine Hypersensitivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
113 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Dentifrice containing stannous fluoride
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
Marketed dentifrice containing Sodium Monofluorophosphate
Intervention Type
Drug
Intervention Name(s)
Stannous Fluoride
Intervention Description
dentifrice containing stannous fluoride
Intervention Type
Drug
Intervention Name(s)
Sodium Monofluorophosphate
Intervention Description
dentifrice containing Sodium Monofluorophosphate
Primary Outcome Measure Information:
Title
Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 14
Description
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.
Time Frame
Baseline to Day 14
Secondary Outcome Measure Information:
Title
Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale Immediately Post-treatment
Description
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.
Time Frame
Baseline to immediately post treatment administration
Title
Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 3
Description
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.
Time Frame
Baseline to Day 3
Title
Change From Baseline in Tactile Pain Threshold Score at Day 14
Description
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
Time Frame
Baseline to Day 14
Title
Change From Baseline in Tactile Pain Threshold Score at Day 3
Description
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.
Time Frame
Baseline to Day 3
Title
Change From Baseline in Tactile Pain Threshold Score Immediately Post-treatment
Description
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.
Time Frame
Baseline to immediately post treatment administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
- Subjects who suffer from tooth sensitivity.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
BioSci Research America, Inc.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89121
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27093773
Citation
Parkinson CR, Hughes N, Hall C, Whelton H, Gallob J, Mason S. Three randomized clinical trials to assess the short-term efficacy of anhydrous 0.454% w/w stannous fluoride dentifrices for the relief of dentin hypersensitivity. Am J Dent. 2016 Feb;29(1):25-32.
Results Reference
derived
Learn more about this trial
Clinical Efficacy of a Toothpaste in Providing Relief From the Pain of Dentinal Hypersensitivity
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