Clinical trial NCT06960148: Dentinal Hypersensitivity Reduction Efficacy Study
Official title: Clinical Investigation of the Dentinal Hypersensitivity Reduction Efficacy of CSPR Toothpaste Containing 8% Arginine Compared to Colgate Cavity Protection Toothpaste Immediately Following Direct Topical Application of the Product and After Subsequent Brushing With the Product for Eight Weeks.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Sensitivity, Tooth
Keywords: hypersensitivity
dentin
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2025-05-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will be monocentric, randomized, double-blind, two-treatment, parallel clinical study
Primary purpose: TREATMENT

Brief summary: Assess the clinical efficacy of CSPR Toothpaste containing 8% arginine to provide dentinal hypersensitivity relief

Detailed description: The objective of this study is to assess the clinical efficacy of CSPR Toothpaste containing 8% arginine to provide dentinal hypersensitivity relief (tactile and air blast) at instant, 3 days, 4 weeks and 8 weeks in comparison to Colgate Cavity Protection Toothpaste over an eight-week period.

Eligibility criteria: 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. 2. 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.

Primary outcomes:
measure: Tactile Sensitivity using the Yeaple Electronic Force Sensing Probe
timeFrame: baseline, 3 day, 4 weeks, 8 weeks
measure: Air Sensitivity using the Schiff Cold Air Sensitivity Scale
timeFrame: baseline, 3 day, 4 weeks, 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Dental Institute of Chengdu
state: Sichuan
Study officials:
References: