Dentinal Hypersensitivity Reduction Efficacy Study

Phase 3

Recruiting

• Conditions: Sensitivity, Tooth
• Interventions: Drug: CSPR Toothpaste; Drug: Colgate Dental Cream Toothpaste

• Registration Number: NCT06960148
• Lead Sponsor: Colgate Palmolive

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2025-03-04
• Status Verified: 2025-04
• Study First Submitted: 2025-04-22
• Study First Submitted QC: 2025-04-28
• Last Update Submitted: 2025-04-28
• Study First Posted: 2025-05-07
• Last Update Posted: 2025-05-07
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test Toothpaste	CSPR Toothpaste	Subjects will be instructed to brush their teeth with their assigned teeth dentifrice and toothbrush twice daily
Control toothpaste	Colgate Dental Cream Toothpaste	Subjects will be instructed to brush their teeth with their assigned teeth dentifrice and toothbrush twice daily

Primary Outcome Measures

Name	Time	Method
Tactile Sensitivity using the Yeaple Electronic Force Sensing Probe	baseline, 3 day, 4 weeks, 8 weeks	Tactile sensitivity will be assessed by use of Sensing Probe Yeaple Electronic Force Sensing Probe, Model 200A. Sensitivity will be defined by a score in the range of 10-50 gms. of force.
Air Sensitivity using the Schiff Cold Air Sensitivity Scale	baseline, 3 day, 4 weeks, 8 weeks	The air will be directed at the exposed buccal surface of the sensitive tooth air delivered by a standard dental unit syringe at a measured temperature of 19-21°C (70°F\[± 3°F\].

Trial Locations

Locations (1)

West China Dental Institute of Chengdu; 🇨🇳 Chengdu, Sichuan, China