Hypersensitivity Reduction Efficacy: 5% Potassium Nitrate Toothpaste Compared to Colgate Cavity Protection Toothpaste

NCT06956599 | Completed Phase 3

• 1 other identifier: CRO-2025-04-SEN-PNT-YPZ
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Assess the clinical efficacy of 5% Potassium Nitrate Toothpaste (Colgate-Palmolive Company, New York, NY, USA) on providing dentinal hypersensitivity relief (tactile and air blast) in comparison to Colgate Cavity Protection Toothpaste (Colgate-Palmolive Company, New York, NY, USA) over an eight-week period

Conditions

Dentin Hypersensitivity

Outcome Measures

Primary Outcomes (1)

• tactile sensitivity

  tactile stimulation is measured by the Yeaple Electronic Force Sensing Probe

  baseline and 4 weeks, 8 week measurement

Secondary Outcomes (1)

• air blast sensitivity

  baseline and 4 weeks, 8 week measurement

Study Arms (2)

Test 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 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.
• Use in the past of the three test dentifrices.

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

West China Dental Institute of Chengdu

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

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 25, 2025
• First Posted: May 4, 2025
• Study Start: May 10, 2025
• Primary Completion: August 11, 2025
• Study Completion: August 11, 2025
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

CN (1)