Hypersensitivity
Conditions
Brief summary
The objective of this study is to assess clinical efficacy of a toothpaste containing 8% arginine (Colgate-Palmolive Company, New York, NY, USA) to provide dental 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
DRUGToothpaste containing 8% Arginine
Brush twice daily (morning and evening) for one full minute Cover the entire length of bristles with toothpaste
Brush twice daily (morning and evening) for one full minute Cover the entire length of bristles with 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 two test dentifrices.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tactile stimulation with a Yeaple Probe. treatment Tactile and Air Blast Hypersensitivity scores. The mean Tactile and Air Blast Hypersensitivity will be computed and summarized | Baseline 4 week & 8 week | Sensitivity will be defined by a score in the range of 10-50 gms. of force |
| Schiff Cold Air Sensitivity Scale | Baseline 4 week & 8 week | Sensitivity will be defined by a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale |
Countries
United States
Outcome results
None listed