Dentinal Hypersensitivity
Conditions
Keywords
tactile, airblast, dentin hypersensitivity
Brief summary
The objective of this clinical study is to assess the efficacy of a dentifrice containing stannous fluoride (Colgate-Palmolive Company, New York, NY, USA) as compared to a commercially-available potassium-based toothpaste (Sensodyne Extra Whitening Toothpaste, GlaxoSmithKline Co., UK) and a commercially available non-desensitizing toothpaste (Colgate Cavity Protection Toothpaste, Colgate-Palmolive Company, New York, NY, USA) in the reduction of dentinal hypersensitivity over a seven (7) day period.
Interventions
DRUGColgate SNF
toothpaste
DRUGSensodyne Extra Whitening
toothpaste
DRUGColgate Fluoride (CDC)
toothpaste
Sponsors
Colgate Palmolive
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Sign an Informed Consent Form; * Male or female 18 to 70 years of age, inclusive; * Be in good general health as determined by the study investigators; * Available for the seven (7) days duration of the study; * Must present two (2) sensitive teeth which must meet ALL of the following criteria: * Be anterior to the molars and demonstrating dentin exposure due to cervical erosion/abrasion and/or gingival recession; * Have a qualifying dentin hypersensitivity response to tactile stimuli applied to the cervical surface (gingivo-facial 1/3) as defined by a response score between 10- 50grams of force (Yeaple Probe, XiniX Research Inc. Portsmouth, NH, USA); * Have a qualifying dentin hypersensitivity response to air blast stimuli applied for one second to the cervical surface (gingivo-facial 1/3) as defined by a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale
Exclusion criteria
* Gross oral pathology, chronic disease, and/or history of allergies to any of the test products; * Use of a desensitizing oral care product and/or recipient of any dental desensitizing treatment within the past three months prior to start of the study; * Advanced periodontal disease and/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 any other oral clinical study for the duration of this study * Self-reported pregnancy and/or currently breastfeeding; * Allergies to oral care products, personal care consumer products, and/or their ingredients; * Medical condition which prohibits not eating/drinking for 4 hours.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tactile dentin hypersensitivity | Baseline, 1-Day, 3-Days and 7-Days | Have a qualifying dentin hypersensitivity response to tactile stimuli applied to the cervical surface (gingivo-facial 1/3) as defined by a response score between 10- 50grams of force (Yeaple Probe, XiniX Research Inc. Portsmouth, NH, USA) |
| Air blast dentin hypersensitivity | Baseline, 1-Day, 3-Days and 7-Days | Have a qualifying dentin hypersensitivity response to air blast stimuli applied for one second to the cervical surface (gingivo-facial 1/3) as defined by a score of 2 or 3 on the Schiff Cold Air Sensitivity Scale. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORFarid Ayad, DMD, MSD
Mesa Dental Centre
Outcome results
None listed