Clinical of Hypersensitivity Reduction Efficacy on Two Toothpastes

Clinical Investigation of Hypersensitivity Reduction Efficacy on Colgate Dual Zinc Toothpaste Containing 5% Small Particle Size Silica (AC43) as Compared to Colgate MaxFresh Tea Toothpaste

To evaluate the clinical efficacy of a Dual Zinc Toothpast containing 5% small particle size silica (AC43) as compared to Colgate MaxFresh Tea Toothpaste on dentin hypersensitivity reduction after brushing two times daily (morning and evening) for a period of 8 weeks

Study Overview

• Status: Completed
• Conditions: Hypersensitivity
• Intervention / Treatment: Drug: Test toothpaste; Drug: Control toothpaste

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

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.
• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test 1 toothpaste; Subjects will be instructed to brush their teeth with their assigned test dentifrice and toothbrush twice daily	Drug: Test toothpaste; A commercially available fluoride toothpaste
Active Comparator: Control toothpaste; Subjects will be instructed to brush their teeth with their assigned test dentifrice and toothbrush twice daily	Drug: Control toothpaste; A commercially available fluoride toothpaste

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tactile sensitivity	tactile stimulation is measured by the Yeaple Electronic Force Sensing Probe	baseline and 8 week measurement
air blast sensitivity	air blast sensitivity is delivered by a standard dental unit syringe at a measured temperature of 19-21°C (70°F [± 3°F]) [sensitivity will be defined by a score of 2 or 3 on the Schiff Cold Air sensitivity scale Air Sensitivity Scale	baseline and 8 week measurement

Collaborators and Investigators

• Sponsor: Colgate Palmolive
• Investigators: Principal Investigator: Deyu Hu, DDS, MS, West China Dental Institute of Chengdu

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2024
• Primary Completion (Actual): December 13, 2024
• Study Completion (Actual): December 13, 2024

Study Registration Dates

• First Submitted: April 14, 2025
• First Submitted That Met QC Criteria: April 14, 2025
• First Posted (Actual): April 22, 2025

Study Record Updates

• Last Update Posted (Actual): April 22, 2025
• Last Update Submitted That Met QC Criteria: April 14, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: CRO-2024-09-SEN-ZN-YPZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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