Back to resultsA Clinical Study to Determine the Safety and Effectiveness of Dentinal Hypersensitivity Treatment With Two Different Toothbrushes
Primary Purpose
Dentin Sensitivity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Potassium Oxalate
Stannous fluoride paste
Manual toothbrush
Power toothbrush
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;
- provide written informed consent prior to participation and be given a signed copy of the informed consent form;
- complete a photography consent agreement pertaining to the collection and use of non-identifying intraoral photographs;
- be in good general health as determined by the Investigator/designee; and
- have at least one tooth with a Schiff sensitivity score of at least 1 in response to the cool air challenge.
Exclusion Criteria:
- self-reported pregnancy or nursing;
- severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession;
- active treatment of periodontitis;
- any diseases or conditions that might interfere with the safe completion of the study; or
- an inability to undergo any study procedures.
Sites / Locations
- Chad J Anderson DMD Inc
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
oxalate liquid, SnF2 paste, manual toothbrush
oxalate liquid, SnF2 paste, power toothbrush
Arm Description
Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Manual toothbrush
Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Power toothbrush
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. The higher the Schiff score, the more sensitive the tooth. 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02513212
Brief Title
A Clinical Study to Determine the Safety and Effectiveness of Dentinal Hypersensitivity Treatment With Two Different Toothbrushes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (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 determine the effects toothbrush type (power or manual) has on the safety and effectiveness of professional dentinal hypersensitivity treatment with a marketed oxalate-containing solution.
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
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
oxalate liquid, SnF2 paste, manual toothbrush
Arm Type
Other
Arm Description
Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Manual toothbrush
Arm Title
oxalate liquid, SnF2 paste, power toothbrush
Arm Type
Other
Arm Description
Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Power toothbrush
Intervention Type
Device
Intervention Name(s)
Potassium Oxalate
Intervention Description
Professionally applied liquid
Intervention Type
Drug
Intervention Name(s)
Stannous fluoride paste
Intervention Description
SnF2 Paste
Intervention Type
Device
Intervention Name(s)
Manual toothbrush
Intervention Description
Marketed manual toothbrush
Intervention Type
Device
Intervention Name(s)
Power toothbrush
Intervention Description
Marketed power toothbrush
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. The higher the Schiff score, the more sensitive the tooth. The mean change from Baseline was calculated for this measure.
Time Frame
30 days
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.
Time Frame
30 days
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;
complete a photography consent agreement pertaining to the collection and use of non-identifying intraoral photographs;
be in good general health as determined by the Investigator/designee; and
have at least one tooth with a Schiff sensitivity score of at least 1 in response to the cool air challenge.
Exclusion Criteria:
self-reported pregnancy or nursing;
severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession;
active treatment of periodontitis;
any diseases or conditions that might interfere with the safe completion of the study; or
an inability to undergo any study procedures.
Facility Information:
Facility Name
Chad J Anderson DMD Inc
City
Fresno
State/Province
California
ZIP/Postal Code
93730
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Clinical Study to Determine the Safety and Effectiveness of Dentinal Hypersensitivity Treatment With Two Different Toothbrushes
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