Dentinal Hypersensitivity Reduction Efficacy Study

NCT06960148 | Completed Phase 3

• 1 other identifier: CRO-2025-02-SEN-CSPR-YPZ
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sensitivity, Tooth

Keywords

hypersensitivity; dentin

Outcome Measures

Primary Outcomes (2)

• Tactile Sensitivity using the Yeaple Electronic Force Sensing Probe

  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.

  baseline, 3 day, 4 weeks, 8 weeks

• Air Sensitivity using the Schiff Cold Air Sensitivity Scale

  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\[± 3°F\].

  baseline, 3 day, 4 weeks, 8 weeks

Study Arms (2)

Test Toothpaste

EXPERIMENTAL

Subjects will be instructed to brush their teeth with their assigned teeth dentifrice and toothbrush twice daily

Drug: CSPR Toothpaste

Control toothpaste

ACTIVE COMPARATOR

Subjects will be instructed to brush their teeth with their assigned teeth dentifrice and toothbrush twice daily

Drug: Colgate Dental Cream Toothpaste

Interventions

CSPR Toothpaste DRUG

a commercially available 8% arginine toothpaste

Test Toothpaste

Colgate Dental Cream Toothpaste DRUG

a commercially available fluoride toothpaste

Control toothpaste

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

West China Dental Institute of Chengdu

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Dentin Sensitivity; Hypersensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The tubes of test dentifrices will present the same shape/color to avoid that both investigators and subjects can identify the dentifrices.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study will be monocentric, randomized, double-blind, two-treatment, parallel clinical study

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 7, 2025
• Study Start: March 4, 2025
• Primary Completion: May 13, 2025
• Study Completion: May 13, 2025
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

CN (1)