A Randomized Clinical Study of the Safety and Effectiveness of Two Dentinal Hypersensitivity Treatments Used With Normal Oral Hygiene
Overview
- Phase
- Not Applicable
- Intervention
- Potassium oxalate
- Conditions
- Dentin Sensitivity
- Sponsor
- Procter and Gamble
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change From Baseline Air Challenge
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
This study will compare the safety and effectiveness of normal oral hygiene with two different marketed dentifrices, on longer term dentinal hypersensitivity response following use of potassium oxalate desensitizers.
Investigators
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 confidentiality disclosure agreement
- •Be in good general health as determined by the Investigator/designee
- •Have at least one tooth with a Schiff sensitivity score of at least 1 in response to the 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
- •Fixed facial orthodontic appliances
- •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
- •Any diseases or conditions that might interfere with the safe completion of the study
- •An inability to undergo any study procedures.
Arms & Interventions
oxalate liquid & gel plus SnF2 paste
Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Stannous fluoride paste, self applied
Intervention: Potassium oxalate
oxalate liquid & gel plus SnF2 paste
Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Stannous fluoride paste, self applied
Intervention: Stannous fluoride paste
oxalate liquid & gel plus NaF paste
Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Sodium fluoride paste, self applied
Intervention: Potassium oxalate
oxalate liquid & gel plus NaF paste
Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Sodium fluoride paste, self applied
Intervention: Sodium fluoride paste
Outcomes
Primary Outcomes
Change From Baseline Air Challenge
Time Frame: 60 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/subjects responds to stimulus and requests discontinuation or moves from 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(60 days)