: 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 (Negative Control) on the Reduction of Dentinal Hypersensitivity.

CRO-2020-05-SEN-SNF-CA-BGS

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.

2020-09-28

2020-10-21

2020-10-21

Completed

Early phase I

123

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.

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2024-02-06