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

Phase 3

Not yet recruiting

• Conditions: Dentin Hypersensitivity
• Interventions: Drug: test toothpaste; Drug: Control toothpaste

• Registration Number: NCT06956599
• Lead Sponsor: Colgate Palmolive

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-25
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-01
• Last Update Submitted: 2025-05-01
• Study First Posted: 2025-05-04
• Last Update Posted: 2025-05-04
• Study Start: 2025-06
• Primary Completion: 2025-06
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test Toothpaste	test toothpaste	Subjects will be instructed to brush their teeth with their assigned test dentifrice and toothbrush twice daily
Control toothpaste	Control toothpaste	Subjects will be instructed to brush their teeth with their assigned test dentifrice and toothbrush twice daily

Primary Outcome Measures

Name	Time	Method
tactile sensitivity	baseline and 4 weeks, 8 week measurement	tactile stimulation is measured by the Yeaple Electronic Force Sensing Probe

Secondary Outcome Measures

Name	Time	Method
air blast sensitivity	baseline and 4 weeks, 8 week measurement	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