Dental Hypersensitivity
Conditions
Brief summary
The objective of this study is to assess clinical efficacy of a toothpaste containing stannous fluoride (Colgate-Palmolive Company, New York, NY, USA) to provide dental hypersensitivity relief (tactile and air blast) in comparison to commercially available potassium-based desensitizing toothpaste (Senodyne Extra Whitening Toothpaste, GasoSmithKline Co., UK) and commercially available non-desensitizing toothpaste (Colgate Cavity Protection Toothpaste, Colgate-Palmolive Company, New York, NY, USA) over a seven day study period
Interventions
DRUG0.454% stannous fluoride toothpaste
brush twice daily (morning and evening) Duration of exposure: one (1) minute
Brush twice daily (morning and evening) Duration of exposure: one (1) minute
Brush twice daily (morning and evening) Duration of exposure: one (1) minute
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
* Must be male or female 18 to 70 years of age * Must give written informed consent * Must be in good general health as determined by the study investigators * Must be available for the seven day duration of the study * Must have 2 hypersensitive teeth which must meet ALL of the following inclusion criteria: Be anterior to the molars and demonstrating dentin exposure due to cervical erosion/abrasion 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
* Allergies to oral care products, personal care consumer products, or their ingredients. * Use of a desensitizing oral care product or recipient of desensitizing treatment within three months prior to start of the study. * Gross oral pathology, 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 any other oral clinical studies for the duration of this study * Full or partial removable oral prostheses * Pregnant or lactating (breast feeding) * 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, 1 day, 3 day, 7 day | 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, 1 day, 3 day, 7 day | 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
United States
Contacts
PRINCIPAL_INVESTIGATORFarid Ayad
FAR ORAL SYSTEMIC HEALTH CONSULTING INC.
PRINCIPAL_INVESTIGATORMaha Hetata
FAR ORAL SYSTEMIC HEALTH CONSULTING INC
Outcome results
None listed