Effect of a mouthrinse containing triclosan and a copolymer on plaque formation in a normal oral hygiene regimen.

A 6-day, double-blind parallel clinical study was conducted to determine the effect on plaque formation of a mouthrinse containing 0.03% [corrected] triclosan (Irgacare MP) and 0.25% of a copolymer of methoxyethylene and maleic acid (Gantrez), as compared to a flavored/colored water placebo mouthrinse. A total of 47 subjects were stratified into two balanced groups using their pre-prophylaxis plaque score. All subjects received a thorough oral prophylaxis at the start of the study. Each group was randomly assigned to the use of either the water placebo mouthrinse or the mouthrinse containing triclosan/copolymer. Subjects rinsed their mouths twice daily (mornings and evenings) for 1 minute with 15 cc of their assigned mouthrinse. Immediately after rinsing, the subjects brushed their teeth for 30 seconds with a commercially available dentifrice containing 0.76% sodium monofluorophosphate in a silica base and a soft-bristled toothbrush. The morning rinsing/brushing procedure was conducted under supervision at the clinical facility. The evening rinsing/brushing procedure was performed at home. After 5 days' use of their assigned mouthrinse, subjects were evaluated by the dental examiner for plaque formation using the modified Quigley-Hein scoring procedure. The results indicated that the triclosan/copolymer mouthrinse provided a 31.03% reduction in plaque formation as compared to the water placebo mouthrinse. This reduction was statistically significant at the 99% level of confidence.

RCT Entities:   Population Interventions Outcomes