Clinical Efficacy of 10% Arginine Bicarbonate Prophylaxis Paste
Condition: Hypersensitivity
MeSH terms: Hypersensitivity
Intervention: Arginine/Calcium Carbonate; Nupro - Fluoride Free
Intervention description: One time treatment; Brush twice daily
Intervention MeSH terms: Calcium Carbonate; Calcium; Fluorides
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of this study is to evaluate the clinical efficacy of a prophylaxis paste
      containing 10% arginine bicarbonate on dentinal hypersensitivity reduction when applied as a
      pre-procedure to a professional dental cleaning.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects, ages 18-70, inclusive.

          -  Availability for the three (3) week duration of the study.

          -  Two (2) sensitive teeth, which must be anterior to the molars, and demonstrate
             cervical erosion/abrasion or gingival recession.

          -  Qualifying response to tactile stimuli (Yeaple probe) as defined by a score between
             10-50gms. of force.

          -  Qualifying response to the air blast stimuli as defined by a score of 2 or 3 on the
             Schiff Cold Air Sensitivity Scale.

          -  Subjects need to satisfy the qualifying response to stimuli for both the parameters
             assessed (tactile or air) on two teeth to be entered into the study.

          -  Good general health with no known allergies to products being tested.

          -  Use of a non-desensitizing dentifrice for three months prior to entry into the study.

          -  Signed Informed Consent Form.

        Exclusion Criteria:

          -  Gross oral pathology, chronic disease, or history of allergy to test products.

          -  Advanced periodontal disease or treatment for periodontal disease (including surgery)
             within the past twelve months.

          -  Scheduled dental prophylaxis within three weeks prior to the Baseline Hypersensitivity
             Examination.

          -  Sensitive teeth with mobility greater than one.

          -  Teeth with extensive/defective restorations (including prosthetic crowns), suspected
             pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures.

          -  Subjects that began to take anticonvulsants, antihistamines, antidepressants,
             sedatives, tranquilizers, anti-inflammatory drugs, or daily analgesics within one
             month prior to the start of the study or who have to start taking these during the
             course of the study.

          -  Participation in a desensitizing dentifrice study or regular use of a desensitizing
             dentifrice within the past three months.

          -  Current participation in any other clinical study.

          -  Pregnant or lactating subjects.

          -  Allergies to oral care products, personal care consumer products, or their
             ingredients.

          -  Medical condition which prohibits not eating/drinking for 4 hours.