Clinical of Hypersensitivity Reduction Efficacy on Two Toothpastes

NCT06937697 | Completed Phase 3

• 1 other identifier: CRO-2024-09-SEN-ZN-YPZ
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypersensitivity

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Test 1 toothpaste

EXPERIMENTAL

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

Drug: Test toothpaste

Control toothpaste

ACTIVE COMPARATOR

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

Drug: Control toothpaste

Interventions

Test toothpaste DRUG

A commercially available fluoride toothpaste

Test 1 toothpaste

Control 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.
• 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

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Deyu Hu, DDS, MS

  West China Dental Institute of Chengdu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 22, 2025
• Study Start: October 8, 2024
• Primary Completion: December 13, 2024
• Study Completion: December 13, 2024
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)