title: Assessment of the effects of a stannous fluoride dentifrice on gingivitis in a two-month positive-controlled clinical study.
abstract: OBJECTIVE
  The purpose of this study was to evaluate the anti-gingivitis effectiveness of a 0.454% stannous fluoride test dentifrice relative to a marketed positive-control triclosan-containing dentifrice in adults with gingivitis.
  
  
  METHODS
  This was a two-month, randomized and controlled, double-blind, parallel group, single-center investigation involving 150 adults with existing mild to moderate gingivitis. Pre-treatment gingivitis levels were assessed at baseline using the Lobene Modified Gingival Index (MGI) and the Gingival Bleeding Index (GBI). Qualified subjects were randomly assigned to either a 0.454% stannous fluoride test dentifrice or a marketed, positive-control 0.30% triclosan/copolymer dentifrice. Subjects then brushed for two months unsupervised in the home setting with their assigned dentifrice per manufacturer's instructions. At Month 2, subjects were re-evaluated for gingivitis via MGI and GBI examinations.
  
  
  RESULTS
  All 150 enrolled subjects completed the trial and were evaluable. Both the stannous fluoride test and triclosan/copolymer control dentifrices provided statistically significant reductions in average MGI, GBI, and number of bleeding sites relative to pre-treatment (p < 0.0001) at Month 2. The adjusted mean improvement from baseline at Month 2 for the stannous fluoride test dentifrice group was 65% greater for number of bleeding sites, 62% greater for GBI, and 45% greater for MGI compared to the triclosan/copolymer positive-control group, with groups differing significantly (p < 0.0001) via each of the three gingivitis measures. Both dentifrices were well-tolerated.
  
  
  CONCLUSIONS
  An advanced stannous fluoride test dentifrice provided superior reductions in gingival inflammation and gingival bleeding compared to a commercially available triclosan/copolymer positive-control dentifrice after two months of tooth brushing.
authors.affiliation: Procter & Gamble Company, Mason, OH, USA. he.t@pg.com
authors.forename: Tao
authors.initials: T
authors.lastname: He
authors.forename: Matthew L
authors.initials: ML
authors.lastname: Barker
authors.forename: A R
authors.initials: AR
authors.lastname: Biesbock
authors.forename: N C
authors.initials: NC
authors.lastname: Sharma
authors.forename: J
authors.initials: J
authors.lastname: Qaqish
authors.forename: C R
authors.initials: CR
authors.lastname: Goyal
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D003802:Dentifrices / Q000737:chemistry / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005891:Gingivitis / Q000517:prevention & control*; D006801:Humans; D008297:Male; D008298:Maleates / Q000627:therapeutic use; D008875:Middle Aged; D010512:Periodontal Index; D010710:Phosphates / Q000627:therapeutic use*; D011145:Polyvinyls / Q000627:therapeutic use; D011446:Prospective Studies; D012824:Silicic Acid / Q000627:therapeutic use; D014002:Tin Fluorides / Q000627:therapeutic use*; D014100:Toothpastes / Q000627:therapeutic use; D014260:Triclosan / Q000627:therapeutic use; D055815:Young Adult
chemical_list: C510825:Crest Pro-Health Dentifrice; D003802:Dentifrices; D004338:Drug Combinations; D008298:Maleates; D010710:Phosphates; D011145:Polyvinyls; D014002:Tin Fluorides; D014100:Toothpastes; C546060:hydrated silica gel-based toothpaste; C058026:polyvinylmethoxyethylene-maleic anhydride copolymer; D012824:Silicic Acid; D014260:Triclosan