Dentinal Hypersensitivity Reduction Efficacy Study

March 17, 2026 updated by: Colgate Palmolive

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

95

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Dental Institute of Chengdu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test Toothpaste
Subjects will be instructed to brush their teeth with their assigned teeth dentifrice and toothbrush twice daily
Drug: CSPR Toothpaste
a commercially available 8% arginine toothpaste
Active Comparator: Control toothpaste
Subjects will be instructed to brush their teeth with their assigned teeth dentifrice and toothbrush twice daily
Drug: Colgate Dental Cream Toothpaste
a commercially available fluoride toothpaste

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tactile Sensitivity using the Yeaple Electronic Force Sensing Probe
Time Frame: 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.
baseline, 3 day, 4 weeks, 8 weeks
Air Sensitivity using the Schiff Cold Air Sensitivity Scale
Time Frame: 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].
baseline, 3 day, 4 weeks, 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Colgate Palmolive

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2025

Primary Completion (Actual)

May 13, 2025

Study Completion (Actual)

May 13, 2025

Study Registration Dates

First Submitted

April 22, 2025

First Submitted That Met QC Criteria

April 28, 2025

First Posted (Actual)

May 7, 2025

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRO-2025-02-SEN-CSPR-YPZ

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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