Back to resultsA Clinical Study to Compare Professional Treatments for Dentinal Hypersensitivity
Primary Purpose
Dentinal Hypersensitivity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Super Seal® Desensitizer
Acclean® Fluoride Varnish
Sponsored by
About this trial
This is an interventional treatment trial for Dentinal Hypersensitivity
Eligibility Criteria
Inclusion Criteria:
- be at least 18 years of age;
- provide written informed consent prior to participation and be given a signed copy of the informed consent form;
- be in good general health as determined by the Investigator/designee; and
- have at least one tooth with a VAS score of greater than or equal to 30 in response to the air challenge.
Exclusion Criteria:
- allergy to rosin or to pine nuts;
- self-reported pregnancy or nursing;
- severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession;
- active treatment for periodontitis;
- fixed facial orthodontic appliances;
- any diseases or conditions that might interfere with the safe completion of the study; or
- an inability to undergo any study procedures.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Super Seal® Desensitizer
Acclean® Fluoride Varnish
Arm Description
Professionally Applied
Professionally Applied
Outcomes
Primary Outcome Measures
Change From Baseline Air Challenge
The Schiff Sensitivity Scale was assessed for each test tooth via an evaporative air challenge. The examiner recorded the Schiff Index score corresponding to the response to the air 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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03405259
Brief Title
A Clinical Study to Compare Professional Treatments for Dentinal Hypersensitivity
Official Title
A Pilot Clinical Study to Compare Professional Treatments for Dentinal Hypersensitivity
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
June 26, 2013 (Actual)
Primary Completion Date
September 13, 2013 (Actual)
Study Completion Date
September 13, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Procter and Gamble
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
Brief Summary
The objective of this study is to compare professional treatments for dentinal hypersensitivity immediately following a single, professionally-applied treatment and again approximately 2 months following treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentinal Hypersensitivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Super Seal® Desensitizer
Arm Type
Experimental
Arm Description
Professionally Applied
Arm Title
Acclean® Fluoride Varnish
Arm Type
Sham Comparator
Arm Description
Professionally Applied
Intervention Type
Device
Intervention Name(s)
Super Seal® Desensitizer
Intervention Description
Single dose professional application.
Intervention Type
Device
Intervention Name(s)
Acclean® Fluoride Varnish
Intervention Description
Single dose professional application.
Primary Outcome Measure Information:
Title
Change From Baseline Air Challenge
Description
The Schiff Sensitivity Scale was assessed for each test tooth via an evaporative air challenge. The examiner recorded the Schiff Index score corresponding to the response to the air 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
Within 5 minutes after treatment was applied
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.
Time Frame
Within 5 minutes after treatment was applied
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;
provide written informed consent prior to participation and be given a signed copy of the informed consent form;
be in good general health as determined by the Investigator/designee; and
have at least one tooth with a VAS score of greater than or equal to 30 in response to the air challenge.
Exclusion Criteria:
allergy to rosin or to pine nuts;
self-reported pregnancy or nursing;
severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession;
active treatment for periodontitis;
fixed facial orthodontic appliances;
any diseases or conditions that might interfere with the safe completion of the study; or
an inability to undergo any study procedures.
12. IPD Sharing Statement
Learn more about this trial
A Clinical Study to Compare Professional Treatments for Dentinal Hypersensitivity
We'll reach out to this number within 24 hrs