Back to resultsPilot Study to Investigate the Efficacy of a Toothpaste in Providing Relief From Dentinal Hypersensitivity
Primary Purpose
Dentinal Sensitivity, Hypersensitivity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Test Toothpaste
Negative Control Toothpaste
Sponsored by
About this trial
This is an interventional treatment trial for Dentinal Sensitivity focused on measuring dentinal, hypersensitivity
Eligibility Criteria
Inclusion:
- Self-reported history of dentinal hypersensitivity lasting more than 6 months and less than 10 years
- Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion.
- Teeth having a gingival index score of less than or equal to 1
- Teeth with a clinical mobility less than or equal to 1
- sensitive teeth from those meeting the EAR, GI and mobility criteria at screening, with sensitivity as measured by tactile stimulus (Yeaple probe, tactile threshold 10g) and evaporative (air) stimulus (Schiff Sensitivity Score ≥ 2).
Exclusion:
- Presence of chronic debilitating disease which could affect study outcomes.
- Any condition which causes xerostomia.
- Dental prophylaxis within 4 weeks of screening.
- Tongue or lip piercing or presence of dental implants.
- Professional desensitising treatment within 12 weeks of screening.
- Gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of screening, scaling or root planning within 3 months of screening.
- Teeth bleaching within 12 weeks of screening.
- Tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of screening.
- Tooth with exposed dentine but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, teeth with full crowns or veneers, orthodontic bands or cracked enamel. Sensitive teeth with contributing aetiologies other than erosion, abrasion or recession of exposed dentine, or not expected to respond to treatment with an over-the counter dentifrice.
- Daily doses of a medication which could interfere with the perception of pain.
- Currently taking antibiotics or have taken antibiotics within 2 weeks of baseline.
- Individuals who require antibiotic prophylaxis for dental procedures.
Sites / Locations
- BioSci Research America, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Toothpaste containing 0.454% stannous fluoride
Toothpaste containing 0.76% sodium monofluorophosphate
Arm Description
USA marketed toothpaste [test]
USA marketed toothpaste [negative control]
Outcomes
Primary Outcome Measures
Adjusted Mean Change From Baseline in Tooth Hypersensivity to Air Stimuli Immediately Following Treatment
Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity).0= no response; 1= response and no discontinuation request; 2= response and discontinuation request; 3= painful response and discontinuation request. Change was calculated as Schiff score immediately after treatment minus Schiff score at baseline.
Secondary Outcome Measures
Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 3
Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity). 0=No participant response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested. Change was Schiff score on Day 3 minus Schiff score at baseline.
Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 14
Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity). 0=No participant response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested. Change was Schiff score on Day 14 minus Schiff score at baseline.
Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately After Treatment
Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 80 grams of force applied to hypersensitive tooth until pain was elicited. Grams of force needed to elicit pain was recorded as hypersensitivity score for the tooth. The higher the score, the lower the hypersensitivity. Hypersensitivity scores on a per study participant basis was recorded as mean scores of all hypersensitive teeth. Change was calculated as mean score immediately after treatment minus mean score at baseline.
Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately at Day 3
Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 80 grams of force applied to hypersensitive tooth until pain was elicited. Grams of force needed to elicit pain was recorded as hypersensitivity score for the tooth. The higher the score, the lower the hypersensitivity. Hypersensitivity scores on a per study participant basis was recorded as mean scores of all hypersensitive teeth. Change was calculated as mean score at Day 3 minus mean score at baseline.
Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately at Day 14
Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 80 grams of force applied to hypersensitive tooth until pain was elicited. Grams of force needed to elicit pain was recorded as hypersensitivity score for the tooth. The higher the score, the lower the hypersensitivity. Hypersensitivity scores on a per study participant basis was recorded as mean scores of all hypersensitive teeth. Change was calculated as mean score at Day 14 minus mean score at baseline.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01494649
Brief Title
Pilot Study to Investigate the Efficacy of a Toothpaste in Providing Relief From Dentinal Hypersensitivity
Official Title
A Pilot Clinical Study Investigating the Efficacy of a Toothpaste in Providing Immediate and Short Term Relief From Dentinal Hypersensitivity
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (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 pilot study to determine the ability of a stannous fluoride containing toothpaste to provide immediate and short term relief from dentine Hypersensitivity compared to a control toothpaste.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentinal Sensitivity, Hypersensitivity
Keywords
dentinal, hypersensitivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
118 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Toothpaste containing 0.454% stannous fluoride
Arm Type
Active Comparator
Arm Description
USA marketed toothpaste [test]
Arm Title
Toothpaste containing 0.76% sodium monofluorophosphate
Arm Type
Other
Arm Description
USA marketed toothpaste [negative control]
Intervention Type
Drug
Intervention Name(s)
Test Toothpaste
Intervention Description
0.454% stannous fluoride toothpaste
Intervention Type
Drug
Intervention Name(s)
Negative Control Toothpaste
Intervention Description
0.76% sodium monofluorophosphate toothpaste
Primary Outcome Measure Information:
Title
Adjusted Mean Change From Baseline in Tooth Hypersensivity to Air Stimuli Immediately Following Treatment
Description
Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity).0= no response; 1= response and no discontinuation request; 2= response and discontinuation request; 3= painful response and discontinuation request. Change was calculated as Schiff score immediately after treatment minus Schiff score at baseline.
Time Frame
Baseline and immediately after treatment administration
Secondary Outcome Measure Information:
Title
Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 3
Description
Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity). 0=No participant response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested. Change was Schiff score on Day 3 minus Schiff score at baseline.
Time Frame
Baseline and Day 3
Title
Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 14
Description
Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity). 0=No participant response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested. Change was Schiff score on Day 14 minus Schiff score at baseline.
Time Frame
Baseline and Day 14
Title
Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately After Treatment
Description
Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 80 grams of force applied to hypersensitive tooth until pain was elicited. Grams of force needed to elicit pain was recorded as hypersensitivity score for the tooth. The higher the score, the lower the hypersensitivity. Hypersensitivity scores on a per study participant basis was recorded as mean scores of all hypersensitive teeth. Change was calculated as mean score immediately after treatment minus mean score at baseline.
Time Frame
Baseline and immediately after treatment administration
Title
Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately at Day 3
Description
Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 80 grams of force applied to hypersensitive tooth until pain was elicited. Grams of force needed to elicit pain was recorded as hypersensitivity score for the tooth. The higher the score, the lower the hypersensitivity. Hypersensitivity scores on a per study participant basis was recorded as mean scores of all hypersensitive teeth. Change was calculated as mean score at Day 3 minus mean score at baseline.
Time Frame
Baseline and Day 3
Title
Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately at Day 14
Description
Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 80 grams of force applied to hypersensitive tooth until pain was elicited. Grams of force needed to elicit pain was recorded as hypersensitivity score for the tooth. The higher the score, the lower the hypersensitivity. Hypersensitivity scores on a per study participant basis was recorded as mean scores of all hypersensitive teeth. Change was calculated as mean score at Day 14 minus mean score at baseline.
Time Frame
Baseline and Day 14
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
Inclusion:
Self-reported history of dentinal hypersensitivity lasting more than 6 months and less than 10 years
Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion.
Teeth having a gingival index score of less than or equal to 1
Teeth with a clinical mobility less than or equal to 1
sensitive teeth from those meeting the EAR, GI and mobility criteria at screening, with sensitivity as measured by tactile stimulus (Yeaple probe, tactile threshold 10g) and evaporative (air) stimulus (Schiff Sensitivity Score ≥ 2).
Exclusion:
Presence of chronic debilitating disease which could affect study outcomes.
Any condition which causes xerostomia.
Dental prophylaxis within 4 weeks of screening.
Tongue or lip piercing or presence of dental implants.
Professional desensitising treatment within 12 weeks of screening.
Gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of screening, scaling or root planning within 3 months of screening.
Teeth bleaching within 12 weeks of screening.
Tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of screening.
Tooth with exposed dentine but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, teeth with full crowns or veneers, orthodontic bands or cracked enamel. Sensitive teeth with contributing aetiologies other than erosion, abrasion or recession of exposed dentine, or not expected to respond to treatment with an over-the counter dentifrice.
Daily doses of a medication which could interfere with the perception of pain.
Currently taking antibiotics or have taken antibiotics within 2 weeks of baseline.
Individuals who require antibiotic prophylaxis for dental procedures.
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
Pilot Study to Investigate the Efficacy of a Toothpaste in Providing Relief From Dentinal Hypersensitivity
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