Sensitivity, Tooth
Conditions
Keywords
hypersensitivity, dentin
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.
Interventions
DRUGCSPR Toothpaste
a commercially available 8% arginine toothpaste
DRUGColgate Dental Cream Toothpaste
a commercially available fluoride toothpaste
Sponsors
Colgate Palmolive
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The tubes of test dentifrices will present the same shape/color to avoid that both investigators and subjects can identify the dentifrices.
Intervention model description
This study will be monocentric, randomized, double-blind, two-treatment, parallel clinical study
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tactile Sensitivity using the Yeaple Electronic Force Sensing Probe | baseline, 3 day, 4 weeks, 8 weeks | Tactile sensitivity will be assessed by use of Sensing Probe Yeaple Electronic Force Sensing Probe, Model 200A. Sensitivity will be defined by a score in the range of 10-50 gms. of force. |
| Air Sensitivity using the Schiff Cold Air Sensitivity Scale | baseline, 3 day, 4 weeks, 8 weeks | The air will be directed at the exposed buccal surface of the sensitive tooth air delivered by a standard dental unit syringe at a measured temperature of 19-21°C (70°F\[± 3°F\]. |
Countries
China
Outcome results
None listed