A Clinical Study to Determine the Safety and Effectiveness of Dentinal Hypersensitivity Treatment With Two Different Toothbrushes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Change From Baseline Air Challenge
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
oxalate liquid, SnF2 paste, manual toothbrush
Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Manual toothbrush
Intervention: Potassium Oxalate (Device)
oxalate liquid, SnF2 paste, manual toothbrush
Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Manual toothbrush
Intervention: Stannous fluoride paste (Drug)
oxalate liquid, SnF2 paste, manual toothbrush
Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Manual toothbrush
Intervention: Manual toothbrush (Device)
oxalate liquid, SnF2 paste, power toothbrush
Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Power toothbrush
Intervention: Potassium Oxalate (Device)
oxalate liquid, SnF2 paste, power toothbrush
Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Power toothbrush
Intervention: Stannous fluoride paste (Drug)
oxalate liquid, SnF2 paste, power toothbrush
Potassium oxalate liquid, professionally applied Stannous fluoride paste, self applied Power toothbrush
Intervention: Power toothbrush (Device)
Outcomes
Primary Outcomes
Change From Baseline Air Challenge
Time Frame: 30 days
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 Outcomes
- Change From Baseline Visual Analog Scale(30 days)