Status:
NOT_YET_RECRUITING
Hypersensitivity Reduction Efficacy: 5% Potassium Nitrate Toothpaste Compared to Colgate Cavity Protection Toothpaste
Lead Sponsor:
Colgate Palmolive
Conditions:
Dentin Hypersensitivity
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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 Co...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06956599
Start Date
June 1 2025
End Date
June 1 2025
Last Update
May 4 2025
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