Back to resultsA Study to Evaluate the Safety and Efficacy of an Oxalate Strip on Adjacent Teeth With Dentinal Hypersensitivity
Primary Purpose
Dentin Sensitivity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Crest® Sensi-Stop™ Strips
Sponsored by
About this trial
This is an interventional treatment trial for Dentin Sensitivity focused on measuring Sensitivity
Eligibility Criteria
Inclusion Criteria:
- be at least 18 years of age
- sign an informed consent form and be given a copy
- be in good general health as determined by the Investigator/designee
- have at least one pair of adjacent teeth, each of which has a screening score of - -greater than or equal to 1 on the Schiff Sensitivity Scale in response to the cold water challenge.
Exclusion Criteria:
- severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession
- active treatment for periodontitis
- any diseases or conditions that might interfere with the subject safely completing the study
- inability to undergo study procedures
- fixed facial orthodontic appliances
- self-reported pregnancy or nursing
- a history of kidney stones
- known allergies to the following ingredients; aqua, glycerin, cellulose gum, dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, and potassium sorbate.
Sites / Locations
- Oral Health Science Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Crest® Sensi-Stop™ Strips
Arm Description
Self Applied
Outcomes
Primary Outcome Measures
Change From Baseline Cold Water Challenge
The Schiff Sensitivity Scale was assessed for each test tooth via a cold water challenge. The examiner recorded the Schiff Index score corresponding to the response to the cold water challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A negative change from Baseline score represents a decrease in sensitivity from baseline. The mean change from Baseline was calculated for this measure.
Secondary Outcome Measures
Change From Baseline Visual Analog Scale
Visual Analog Scale (VAS) - subjects are asked to look at a VAS and designate the level of hypersensitivity they experienced as a result of the thermal and water challenges using a continuum scale of 0 = No tooth pain up to 100 = Worst tooth pain ever experienced. A negative change from Baseline score represents a decrease in sensitivity from baseline. The mean change from Baseline was calculated for this measure.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02293044
Brief Title
A Study to Evaluate the Safety and Efficacy of an Oxalate Strip on Adjacent Teeth With Dentinal Hypersensitivity
Official Title
A Pilot Clinical Study to Evaluate the Safety and Efficacy of a Self-Applied Oxalate Strip on Adjacent Teeth With Dentinal Hypersensitivity
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Procter and Gamble
4. Oversight
5. Study Description
Brief Summary
This study will compare the safety and effectiveness of a potassium oxalate desensitizer on adjacent teeth with dentinal hypersensitivity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Sensitivity
Keywords
Sensitivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Crest® Sensi-Stop™ Strips
Arm Type
Experimental
Arm Description
Self Applied
Intervention Type
Device
Intervention Name(s)
Crest® Sensi-Stop™ Strips
Primary Outcome Measure Information:
Title
Change From Baseline Cold Water Challenge
Description
The Schiff Sensitivity Scale was assessed for each test tooth via a cold water challenge. The examiner recorded the Schiff Index score corresponding to the response to the cold water challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A negative change from Baseline score represents a decrease in sensitivity from baseline. The mean change from Baseline was calculated for this measure.
Time Frame
1 Day
Secondary Outcome Measure Information:
Title
Change From Baseline Visual Analog Scale
Description
Visual Analog Scale (VAS) - subjects are asked to look at a VAS and designate the level of hypersensitivity they experienced as a result of the thermal and water challenges using a continuum scale of 0 = No tooth pain up to 100 = Worst tooth pain ever experienced. A negative change from Baseline score represents a decrease in sensitivity from baseline. The mean change from Baseline was calculated for this measure.
Time Frame
1 Day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
be at least 18 years of age
sign an informed consent form and be given a copy
be in good general health as determined by the Investigator/designee
have at least one pair of adjacent teeth, each of which has a screening score of - -greater than or equal to 1 on the Schiff Sensitivity Scale in response to the cold water challenge.
Exclusion Criteria:
severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession
active treatment for periodontitis
any diseases or conditions that might interfere with the subject safely completing the study
inability to undergo study procedures
fixed facial orthodontic appliances
self-reported pregnancy or nursing
a history of kidney stones
known allergies to the following ingredients; aqua, glycerin, cellulose gum, dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, and potassium sorbate.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert W Gerlach, DDS, MPH
Organizational Affiliation
Procter and Gamble
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oral Health Science Center
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Safety and Efficacy of an Oxalate Strip on Adjacent Teeth With Dentinal Hypersensitivity
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