Dentin Hypersensitivity
Conditions
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
Interventions
DRUGtest toothpaste
A commercially available fluoride 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)
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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| tactile sensitivity | baseline and 4 weeks, 8 week measurement | tactile stimulation is measured by the Yeaple Electronic Force Sensing Probe |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Outcome results
None listed