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hygiene tribuneDental Tribune Middle East & Africa Edition | January-February 2015 1B A clinical assessment of the efficacy of a Stannous - containing Sodium Fluoride Dentifrice on Dentinal Hypersensitivity > Page 2B By Trevor N. Day, PhD; Johannes Einwag, Prof. Dr. med. dent.; Joachim S. Her- mann, PD Dr. med. dent.; Tao He, DDS, PhD; Mary Kay Ana- stasia, BA; Matthew Barker, PhD; Yuqing Zhang, MS A im: To measure the de- sensitizing benefits of an experimental stannous- containing sodium fluoride den- tifrice versus a regular sodium fluoride negative control. Methods and Materials: This studywasarandomized,double- blind, parallel group, fourweek clinical trial. Subjects reporting dentinal hypersensitivity were enrolled and randomized to the experimental dentifrice or the control dentifrice to use twice daily for four weeks. Efficacy assessments (Air Blast) were performed at baseline and weeks two and four. Separate analyses were performed for the two most sensitive teeth at base- line and for all 12 teeth. Results for weeks two and four com- bined also were analyzed. Results: Thirty-one subjects were included in the analyses. For the two most sensitive teeth, the experimental dentifrice showed statistically significantly less sensitivity (p<0.05) versus the control at weeks two and four and for weeks two and four combined. The sensitivity re- duction ranged from 24.9% to 28.4% over the control. For all 12 teeth, the experimental group had statistically significantly (p<0.03) lower sensitivity scores versus the control group at week two and weeks two and four combined. Conclusion: The experimental dentifrice demonstrated signifi- cant desensitizing advantages versus the control. Clinical Significance: This stan- nouscontaining sodium fluoride dentifrice provides an effec- tive treatment for patients with dentinal hypersensitivity, sig- nificantly reducing sensitivity versus a negative control in this four-week trial. Keywords: Stan- nous, dentifrice, sodium fluo- ride, sensitivity, clinical trial. Introduction Dentinal hypersensitivity is a highly prevalent condition re- ported to affect from 4% to 57% of the population.1,2 The causes of sensitivity are well character- ized as exposed dentinal tubules most commonly resulting from gingival recession followed by loss of cementum. The mecha- nism by which nerves are trig- gered to result in the pain as- sociated with hypersensitivity is now widely accepted as that of the Brännström hydrodynamic theory.3 This postulates that changing physical conditions on the dentin surface such as heat, pressure, or osmotic potential give rise to fluid movement in the tubules.4–6 The consequent pressure change stimulates the nerves giving rise to the pain. The mechanism of action of stannous ions7 in reducing den- tinal hypersensitivity has been found to be the precipitation of stannous compounds occlud- ing the dentinal tubules and thus preventing stimulation of the nerves in the pulp cavity. In vitro studies using various tech- niques, such as scanning elec- tron microscopy, electron probe microanalysis, and Vickers sur- face microhardness, demon- strate deposition of tin and fluo- ride on the surface and covering of the dentinal tubules.8,9 One laboratory evaluation showed that while both zinc and tin cov- ered or obturated tubules, zinc was largely removed by wash- ing whereas tin remained cover- ing the tubules.10 Another study showed specimens treated with stannous fluoride (Crest® Pro- Health®, The Procter & Gamble Company, Cincinnati, OH, USA) appeared to resist acid solubili- zation.9 A number of clinical studies also have been conducted to investigate the effectiveness of stannous-containing oral care products upon dentinal hyper- sensitivity. Most of the early studies focused on gels contain- ing 0.4% stannous fluoride,11 whereas the majority of con- temporary trials have evaluated stannous-containing dentifrice formulations.12–18 The collective findings demonstrate the effec- tiveness of numerous stannous- containing products in reducing sensitivity. Recently, a new stannous- containing sodium fluoride dentifrice was developed. This clinical trial was conducted to evaluate the effectiveness of this formulation relative to a nega- tive control for the treatment of dentinal hypersensitivity. Methods and Materials Study Design This was a randomized, parallel group, doubleblind, four-week clinical trial to assess changes in subject perceived tooth hy- persensitivity via air blast in- duced examiner grade assess- ment among subjects using a stannous-containing sodium fluoride dentifrice compared to those using a negative control dentifrice. Measurements were conducted at baseline, week two, and week four visits. Entrance Criteria Following Ethics Committee approval, at least 30 generally healthy adults age 18–70 report- ing tooth sensitivity were sought. Subjects had to agree to refrain from using anti-hypersensitiv- ity products or having elective dental procedures (including prophylaxis) performed during the study. Subjects who were currently using an antisensitivity tooth- paste or another anti- sensitivity product or who had used such a product in the previous month were excluded. Subjects with carious teeth or with any other condition that the investigator considered may compromise the results also were excluded. Subjects taking daily doses of anticonvulsants, sedatives, tran- quilizers, or other mood-altering drugs were excluded as well as subjects with a history of signifi- cant adverse effects following the use of oral hygiene products such as toothpaste and mouth rinse. Test Dentifrices, Assignment to Treatment Sequence The two treatments used in this study were: 1. An experimental stannous- containing sodium fluoride den- tifrice with 1450 ppm F- sodium fluoride and stannous chloride as a key excipient (Procter & Gamble UK, Surrey, United Kingdom) 2. Crest® Decay Protection (UK) with 1450 ppm F- sodium fluo- ride (Procter & Gamble UK, Sur- rey, United Kingdom) Both were supplied to the sub- jects with (medium) Oral-B Ad- vantage 40 toothbrushes (The Procter & Gamble Company, Cincinnati, OH, USA). The test products were supplied in kits containing the assigned tooth- paste, toothbrush, and written usage instructions. The denti- frice in both kits was supplied blinded in white tubes. Subjects were stratified at base- line into one of four strata de- pending on their gender (female or male) and the baseline self- reported tooth hypersensitivity (low or high). Within strata, sub- jects were randomly assigned to one of the two treatment groups using an encoded program. Sub- jects residing in the same house- Originally published in the Journal of Contemporary Dental Practice, 11, No. 1, January 1, 2010