Clinical Study to Assess the Efficacy of a Dentifrice Containing Stannous Fluoride as Compared to a Commercially-available Potassium-based Toothpaste and a Regular Fluoride Toothpaste on the Reduction of Dentinal Hypersensitivity.
Overview
- Phase
- Phase 3
- Intervention
- Colgate SNF
- Conditions
- Dentinal Hypersensitivity
- Sponsor
- Colgate Palmolive
- Enrollment
- 123
- Locations
- 1
- Primary Endpoint
- Tactile dentin hypersensitivity
- Status
- Completed
- Last Updated
- last month
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Group I
Colgate SnF Toothpaste Colgate Adult Extra Clean soft-bristle toothbrush
Intervention: Colgate SNF
Group II
Sensodyne Extra Whitening Toothpaste Colgate Adult Extra Clean soft-bristle toothbrush
Intervention: Sensodyne Extra Whitening
Group III
Colgate Fluoride Toothpaste (CDC) Colgate Adult Extra Clean soft-bristle toothbrush
Intervention: Colgate Fluoride (CDC)
Outcomes
Primary Outcomes
Tactile dentin hypersensitivity
Time Frame: 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
Time Frame: 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.