Dentinal Hypersensitivity Reduction Efficacy Study

NCT ID: NCT06960148

Last Updated: 2025-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-04

Study Completion Date

2025-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Sensitivity, Tooth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study will be monocentric, randomized, double-blind, two-treatment, parallel clinical study
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
The tubes of test dentifrices will present the same shape/color to avoid that both investigators and subjects can identify the dentifrices.

Study Groups

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Test Toothpaste

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

Group Type EXPERIMENTAL

CSPR Toothpaste

Intervention Type DRUG

a commercially available 8% arginine toothpaste

Control toothpaste

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

Group Type ACTIVE_COMPARATOR

Colgate Dental Cream Toothpaste

Intervention Type DRUG

a commercially available fluoride toothpaste

Interventions

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CSPR Toothpaste

a commercially available 8% arginine toothpaste

Intervention Type DRUG

Colgate Dental Cream Toothpaste

a commercially available fluoride toothpaste

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Colgate Palmolive

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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West China Dental Institute of Chengdu

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Deyu Hu, DDS,MS

Role: CONTACT

86-1390-803-4990

Zhi Zhou, DDS,PhD

Role: CONTACT

86-1306-238-1906

Facility Contacts

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Deyu Hu, DDS, MS

Role: primary

86-1390-803-4990

Zhi Zhou, DDS, PhD

Role: backup

86-1306-238-1906

Other Identifiers

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CRO-2025-02-SEN-CSPR-YPZ

Identifier Type: -

Identifier Source: org_study_id

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