A Clinical Study of Two Dentinal Hypersensitivity Treatments Used With Normal Oral Hygiene

Not Applicable

Completed

Interventions: Device: Potassium oxalate
Drug: Stannous fluoride paste
Drug: Sodium fluoride paste

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
oxalate liquid & gel plus SnF2 paste	Potassium oxalate	Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Stannous fluoride paste, self applied
oxalate liquid & gel plus SnF2 paste	Stannous fluoride paste	Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Stannous fluoride paste, self applied
oxalate liquid & gel plus NaF paste	Potassium oxalate	Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Sodium fluoride paste, self applied
oxalate liquid & gel plus NaF paste	Sodium fluoride paste	Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Sodium fluoride paste, self applied

Primary Outcome Measures

Name	Time	Method
Change From Baseline Air Challenge	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 Outcome Measures

Name	Time	Method
Change From Baseline Visual Analog Scale	60 days	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.