Toothpaste for reducing tooth sensitivity

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.

This study is testing if a new toothpaste with arginine can help people with tooth sensitivity feel better compared to a regular toothpaste over eight weeks.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Colgate Palmolive (Industry-sponsored)
• Locations: 1 site (Chengdu, Sichuan)
• Trial ID: NCT06960148 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of CSPR Toothpaste containing 8% arginine in alleviating dentinal hypersensitivity compared to Colgate Cavity Protection Toothpaste. Participants will be assessed for sensitivity relief at multiple time points: immediately, and at 3 days, 4 weeks, and 8 weeks after using the toothpaste. The study focuses on individuals with specific sensitivity responses to tactile and air blast stimuli. It aims to provide evidence on the clinical efficacy of the new toothpaste formulation over an eight-week period.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18-70 with specific tooth sensitivity and no allergies to the tested products.

Not a fit: Patients with gross oral pathology, advanced periodontal disease, or those who have allergies to the test products may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for individuals suffering from dentinal hypersensitivity.

How similar studies have performed: Previous studies have shown promising results for similar toothpaste formulations in reducing tooth sensitivity, indicating a potential for success in this approach.

Eligibility criteria

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.

Where this trial is running

Chengdu, Sichuan

• West China Dental Institute of Chengdu — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Deyu Hu, DDS,MS

Conditions Sensitivity, Tooth; hypersensitivity; dentin