Fast onset sensitivity relief of a 0.454% stannous fluoride dentifrice. 2011

T He, and M L Barker, and J Qaqish, and N Sharma
The Procter & Gamble Company, Mason, OH, USA. he.t@pg.com

OBJECTIVE To evaluate the efficacy ofa stannous fluoride dentifrice as compared to a negative control dentifrice in the reduction of dentinal hypersensitivity after immediate use, and after three days and two weeks of use. METHODS This was a controlled, randomized, examiner-blind, two-treatment, parallel group study conducted among healthy adult male and female subjects with moderate dentinal hypersensitivity. Subjects with at least two sensitive teeth demonstrating reproducible sensitivity to both thermal stimuli (SchiffAir Sensitivity Scale score of > 1) and tactile stimuli (Yeaple probe 10 grams) were randomized to treatment with either a 0.454% stannous fluoride (SnF,) dentifrice (experimental group) or a 0.76% sodium monofluorophosphate dentifrice (negative control group). At baseline, subjects received an oral soft tissue examination, were assessed for tooth sensitivity, and were instructed, according to manufacturer's product instructions, to brush with their assigned dentifrice thoroughly twice a day (morning and evening). Subjects performed their first product use on site under supervision. Immediately following the first treatment, both examiner and subject assessed sensitivity to thermal stimuli for each enrolled tooth using the Schiff Air Sensitivity Scale and air visual analog scale (VAS), respectively. Thermal sensitivity was also assessed (by both examiner and subject) at the Day 3 and Week 2 study visits, together with tactile sensitivity (Yeaple probe) and oral soft tissue exams of the mouth. RESULTS One-hundred and eleven subjects were enrolled and randomized to one of the two treatment groups. Immediately after the first use, the SnF, dentifrice provided statistically significant (p < 0.0001) reductions in sensitivity relative to the negative control dentifrice of 13.8% for the thermal Schiff Air Sensitivity Scale and 14.6% for the air VAS. The SnF, dentifrice also provided statistically significant (p < 0.0001) reductions in sensitivity relative to the negative control at Day 3 and at Week 2 based on the thermal Schiff Air Sensitivity Scale (31.8% and 61.3%, respectively) and the thermal air VAS (34.8% and 66.6%, respectively). For the tactile Yeaple probe, the SnF2 dentifrice demonstrated significantly (p < 0.0001) better sensitivity scores relative to the negative control at Day 3 and Week 2, with improvements of 186% and 239%, respectively. Both dentifrices were well tolerated. CONCLUSIONS An experimental 0.454% SnF2 dentifrice provides significantly better immediate and ongoing sensitivity relief relative to a negative control dentifrice.

UI MeSH Term Description Entries
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D010147 Pain Measurement Scales, questionnaires, tests, and other methods used to assess pain severity and duration in patients or experimental animals to aid in diagnosis, therapy, and physiological studies. Analgesia Tests,Analogue Pain Scale,Formalin Test,McGill Pain Questionnaire,Nociception Tests,Pain Assessment,Pain Intensity,Pain Severity,Tourniquet Pain Test,Visual Analogue Pain Scale,Analog Pain Scale,Assessment, Pain,McGill Pain Scale,Visual Analog Pain Scale,Analgesia Test,Analog Pain Scales,Analogue Pain Scales,Formalin Tests,Intensity, Pain,Measurement, Pain,Nociception Test,Pain Assessments,Pain Intensities,Pain Measurements,Pain Questionnaire, McGill,Pain Scale, Analog,Pain Scale, Analogue,Pain Scale, McGill,Pain Severities,Pain Test, Tourniquet,Questionnaire, McGill Pain,Scale, Analog Pain,Scale, Analogue Pain,Scale, McGill Pain,Severity, Pain,Test, Analgesia,Test, Formalin,Test, Nociception,Test, Tourniquet Pain,Tests, Nociception,Tourniquet Pain Tests
D003802 Dentifrices Any preparations used for cleansing teeth; they usually contain an abrasive, detergent, binder and flavoring agent and may exist in the form of liquid, paste or powder; may also contain medicaments and caries preventives. Polishes, Dental,Dental Polishes,Dentifrice
D003807 Dentin Sensitivity Pain associated with exposed DENTIN surfaces of the teeth. Dentin Hypersensitivity,Dentine Hypersensitivity,Dentine Sensitivity,Tooth Sensitivity,Dentin Hypersensitivities,Dentin Sensitivities,Dentine Hypersensitivities,Dentine Sensitivities,Hypersensitivities, Dentin,Hypersensitivities, Dentine,Hypersensitivity, Dentin,Hypersensitivity, Dentine,Sensitivities, Dentin,Sensitivities, Dentine,Sensitivities, Tooth,Sensitivity, Dentin,Sensitivity, Dentine,Sensitivity, Tooth,Tooth Sensitivities
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults
D000704 Analysis of Variance A statistical technique that isolates and assesses the contributions of categorical independent variables to variation in the mean of a continuous dependent variable. ANOVA,Analysis, Variance,Variance Analysis,Analyses, Variance,Variance Analyses
D014002 Tin Fluorides Inorganic fluorides of tin. They include both stannic fluoride (tin tetrafluoride) and stannous fluoride (tin difluoride). The latter is used in the prevention of dental caries. Stannic Fluoride,Stannous Fluoride,Tin Difluoride,Tin Tetrafluoride,Cav-X,Floran,Fluoristan,Gel-Kam,Gel-Tin,Omnii-Gel,Omnii-Med,Stanimax,Difluoride, Tin,Difluorides, Tin,Florans,Fluoride, Stannic,Fluoride, Stannous,Fluoride, Tin,Fluorides, Stannic,Fluorides, Stannous,Fluorides, Tin,Fluoristans,Stanimaxs,Stannic Fluorides,Stannous Fluorides,Tetrafluoride, Tin,Tetrafluorides, Tin,Tin Difluorides,Tin Fluoride,Tin Tetrafluorides

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