Dentinal Hypersensitivity Reduction Efficacy Study

Clinical Investigation of the Dentinal Hypersensitivity Reduction Efficacy of CSPR Toothpaste Containing 8% Arginine Compared to Colgate Cavity Protection Toothpaste Immediately Following Direct Topical Application of the Product and After Subsequent Brushing With the Product for Eight Weeks.

Assess the clinical efficacy of CSPR Toothpaste containing 8% arginine to provide dentinal hypersensitivity relief

The objective of this study is to assess the clinical efficacy of CSPR Toothpaste containing 8% arginine to provide dentinal hypersensitivity relief (tactile and air blast) at instant, 3 days, 4 weeks and 8 weeks in comparison to Colgate Cavity Protection Toothpaste over an eight-week period.

Inclusion Criteria:

• Male and female subjects, ages 18-70, inclusive.
• Availability for the eight-week duration of the study.
• Two 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 10-50 gms. 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. 2. Advanced periodontal disease or treatment for periodontal disease (including surgery) within the past twelve months.
• Sensitive teeth with a 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.
• Current use of anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory drugs, or daily use of analgesics.
• 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.