Randomized clinical trial of two oral care regimens in reducing and controlling established dental plaque and gingivitis.

Abstract

PURPOSE:

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.

METHOD:

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: Farid Ayad, Luis R Mateo, Rensi Dillon, Jeffrey M Miller, Shira Pilch, Bernal Stewart
• Journal: American journal of dentistry (Am J Dent) Vol. 28 Spec No A Pg. 27A-32A (Sep 2015) ISSN: 0894-8275 [Print] United States
• PMID: 26591623 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Mouthwashes
• Phosphates
• Toothpastes
• fluorophosphate
• Cetylpyridinium
• Fluorides

Topics

• Adolescent
• Adult
• Aged
• Cetylpyridinium (therapeutic use)
• Dental Plaque (prevention & control)
• Double-Blind Method
• Fluorides (therapeutic use)
• Gingivitis (prevention & control)
• Humans
• Middle Aged
• Mouthwashes
• Phosphates (therapeutic use)
• Toothpastes