Dentinal Hypersensitivity Reduction Efficacy Study

Last updated: April 28, 2025
Sponsor: Colgate Palmolive
Overall Status: Active - Recruiting

Phase

3

Condition

Allergy (Pediatric)

Allergy

Allergies & Asthma

Treatment

Colgate Dental Cream Toothpaste

CSPR Toothpaste

Clinical Study ID

NCT06960148
CRO-2025-02-SEN-CSPR-YPZ
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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 cervicalerosion/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 theSchiff Cold Air Sensitivity Scale.

  • Subjects need to satisfy the qualifying response to stimuli for both the parametersassessed (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 thestudy.

  • Signed Informed Consent Form.

Exclusion

Exclusion Criteria:

  • Gross oral pathology, chronic disease, or history of allergy to test products. 2.Advanced periodontal disease or treatment for periodontal disease (includingsurgery) within the past twelve months.

  • Sensitive teeth with a mobility greater than one.

  • Teeth with extensive/defective restorations (including prosthetic crowns), suspectedpulpitis, caries, cracked enamel, or used as abutments for removable partialdentures.

  • 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 desensitizingdentifrice 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 theiringredients.

  • Medical condition which prohibits not eating/drinking for 4 hours.

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Colgate Dental Cream Toothpaste
Phase: 3
Study Start date:
March 04, 2025
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • West China Dental Institute of Chengdu

    Chengdu, Sichuan 610041
    China

    Active - Recruiting

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