title: Randomized clinical trial of two oral care regimens in reducing and controlling established dental plaque and gingivitis.
abstract: OBJECTIVE
  To evaluate the efficacy of a test regimen (TR) integrating the use of a commercially available triclosan, PVM/MA copolymer, and sodium fluoride containing toothpaste, an alcohol-free, fluoride-free cetylpyridinium chloride (CPC) mouthwash, and a manual toothbrush with cheek and tongue cleaner compared to a negative control regimen (NCR) integrating a commercially available 0.76% sodium monofluorophosphate toothpaste, a manual toothbrush and a fluoride-free and alcohol-free non-antibacterial mouthwash in the reduction and control of established plaque and gingivitis after 4 weeks of product use.
  
  
  METHODS
  A 4-week, two-cell, double-blind, parallel-group, randomized clinical study was conducted in Cedar Knolls, New Jersey, USA. Recruited subjects were randomly assigned to two regimens: (1) a commercially available toothpaste containing triclosan, PVM/MA copolymer, and 0.243% sodium fluoride, a manual toothbrush with cheek and tongue cleaner, and commercially available mouthwash containing 0.075% CPC in a fluoride-free and alcohol-free base (TR), or (2) a commercially available 0.76% sodium monofluorophosphate toothpaste, a manual toothbrush with rounded/polished bristles, and a fluoride-free and alcohol-free non-antibacterial mouthwash (NCR). Subjects were examined for dental plaque and gingivitis. Gingival, Gingival Severity, Gingival Interproximal, Plaque, Plaque Severity and Plaque Interproximal Index scores were calculated. For regimen comparison, independent t-test and ANCOVA analyses were performed.
  
  
  RESULTS
  130 subjects were screened; 120 enrolled; and 115 subjects completed the randomized clinical trial (RCT). After 4 weeks of product use, subjects using TR exhibited statistically significant (P < 0.001) reductions of 22.3%, 27.8% and 20.4% in mean Gingival, Gingival Severity and Gingival Interproximal Index scores, respectively, as compared to subjects using NCR. After 4 weeks of product use, subjects using TR exhibited statistically significant (P < 0.001) reductions of 28.2%, 60.7% and 27.6% in mean Plaque, Plaque Severity and Plaque Interproximal Index scores, respectively, as compared to subjects using NCR.
authors.forename: Farid
authors.initials: F
authors.lastname: Ayad
authors.forename: Luis R
authors.initials: LR
authors.lastname: Mateo
authors.forename: Rensi
authors.initials: R
authors.lastname: Dillon
authors.forename: Jeffrey M
authors.initials: JM
authors.lastname: Miller
authors.forename: Shira
authors.initials: S
authors.lastname: Pilch
authors.forename: Bernal
authors.initials: B
authors.lastname: Stewart
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002594:Cetylpyridinium / Q000627:therapeutic use*; D003773:Dental Plaque / Q000517:prevention & control*; D004311:Double-Blind Method; D005459:Fluorides / Q000627:therapeutic use*; D005891:Gingivitis / Q000517:prevention & control*; D006801:Humans; D008875:Middle Aged; D009067:Mouthwashes; D010710:Phosphates / Q000627:therapeutic use*; D014100:Toothpastes
chemical_list: D009067:Mouthwashes; D010710:Phosphates; D014100:Toothpastes; C012980:fluorophosphate; D002594:Cetylpyridinium; D005459:Fluorides