A controlled 6-month clinical trial to study the effects of a stannous fluoride dentifrice on gingivitis

A controlled 6-month clinical trial to study the effects of a stannous fluoride dentifrice on gingivitis
Published article online:
23 Jul 2007
Issue online:
16 Aug 2007
Accepted for publication 20 May 2007
To cite this article: Mark Mallatt, Suru Mankodi, Karen Bauroth, Samer A. Bsoul, Robert D. Bartizek, Tao He (2007) A controlled 6-month clinical trial to study the effects of a stannous fluoride dentifrice on gingivitis
Journal of Clinical Periodontology 34 (9) , 762Ò767 doi:10.1111/j.1600-051X.2007.01109.x
Blackwell Synergy

Mark Mallatt11Indiana State Department of Health, Indianapolis, IN, USA; , Suru Mankodi22Dental Products Testing Inc., West Palm Beach, FL, USA; , Karen Bauroth22Dental Products Testing Inc., West Palm Beach, FL, USA; , Samer A. Bsoul33Health Care Research Center, Procter & Gamble Company, Mason, OH, USA, Robert D. Bartizek33Health Care Research Center, Procter & Gamble Company, Mason, OH, USA and Tao He33Health Care Research Center, Procter & Gamble Company, Mason, OH, USA

Conflict of interest and source of funding statement The authors declare that they have no conflict of interest.
Dr. Bsoul, Mr. Bartizek and Dr. He are employed by Procter & Gamble. This study was funded by the Procter & Gamble Company. Dr. Bsoul was an employee of Procter & Gamble at the time the research was conducted and the manuscript was developed.

Address:
Tao He
Health Care Research Center
The Procter & Gamble Company
8700 Mason-Montgomery Rd.
Mason, OH 45040
USA
E-mail: he.t@pg.com
Mallatt M, Mankodi S, Bauroth K, Bsoul SA, Bartizek RD, He T. A controlled 6-month clinical trial to study the effects of a stannous fluoride dentifrice on gingivitis. J Clin Periodontol 2007; 34: 762Ò767. doi: 10.1111/j.1600-051X.2007.01109.x.

Abstract

Objectives: This study was conducted to assess anti-plaque and anti-gingivitis benefits of a stabilized stannous fluoride (SnF2)/sodium hexametaphosphate (SHMP) dentifrice versus a negative control.

Material and Methods: This was a randomized, 6-month, stratified, single-centre, double-blind, parallel group, clinical study conducted in harmony with the guidelines for evaluating chemotherapeutic products for the control of gingivitis outlined by the American Dental Association. A stabilized 0.454% SnF2/SHMP dentifrice was tested against a commercially available negative control dentifrice. Following baseline measurements, subjects received a dental prophylaxis. Subjects were instructed to brush twice daily for 60 s using their assigned product. Efficacy measurements were obtained at baseline, 3 and 6 months post treatment using the Modified Gingival Index, Gingival Bleeding Index and the Turesky Modified Quigley-Hein Plaque Index. Oral tissue examinations were performed at all visits.

Results: A total of 140 subjects were enroled and 128 completed the study. Results after 6 months showed the SnF2 dentifrice delivered a 16.9% reduction in gingivitis (p<0.001), a 40.8% reduction (p<0.001) in gingival bleeding, and an 8.5% reduction in plaque (p=0.001) versus the negative control. Both treatments were well tolerated.

Conclusions: Twice daily use of the SnF2/SHMP dentifrice over 6 months provided statistically significant anti-plaque and anti-gingivitis benefits relative to a negative control.

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