8% Arginine Toothpaste vs. Colgate for Dentinal Hypersensitivity Relief

This clinical study evaluates the effectiveness of CSPR Toothpaste containing 8% arginine in reducing dentinal hypersensitivity compared to Colgate Cavity Protection Toothpaste. The research focuses on both immediate relief and long-term benefits over an eight-week period.

Study Design: This Phase 3, randomized, quadruple-masked trial will enroll approximately 100 healthy adult volunteers aged 18-70. Participants must have at least two sensitive teeth with qualifying responses to both tactile and air blast stimuli.

Methodology: Subjects will be randomly assigned to either the test group (CSPR Toothpaste) or control group (Colgate) and instructed to brush twice daily. Sensitivity measurements will be taken at baseline, 3 days, 4 weeks, and 8 weeks using:

• Yeaple Electronic Force Sensing Probe for tactile sensitivity (10-50 gms force range)
• Schiff Cold Air Sensitivity Scale for air blast sensitivity

Key Inclusion Criteria:

• Good general health with no allergies to test products
• Cervical erosion/abrasion or gingival recession in sensitive teeth
• No use of desensitizing toothpaste for 3 months prior

Exclusion Factors:

• Advanced periodontal disease
• Extensive tooth restorations or caries
• Use of certain medications
• Pregnancy or lactation

The study aims to demonstrate whether the 8% arginine formulation provides superior and longer-lasting relief from tooth sensitivity compared to standard fluoride toothpaste, potentially offering a new solution for millions suffering from dentinal hypersensitivity.