Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
100 participants
INTERVENTIONAL
2025-03-04
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Test Toothpaste
Subjects will be instructed to brush their teeth with their assigned teeth dentifrice and toothbrush twice daily
CSPR Toothpaste
a commercially available 8% arginine toothpaste
Control toothpaste
Subjects will be instructed to brush their teeth with their assigned teeth dentifrice and toothbrush twice daily
Colgate Dental Cream Toothpaste
a commercially available fluoride toothpaste
Interventions
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CSPR Toothpaste
a commercially available 8% arginine toothpaste
Colgate Dental Cream Toothpaste
a commercially available fluoride toothpaste
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
Yes
Sponsors
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Colgate Palmolive
INDUSTRY
Responsible Party
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Locations
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West China Dental Institute of Chengdu
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CRO-2025-02-SEN-CSPR-YPZ
Identifier Type: -
Identifier Source: org_study_id
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