Clinical investigation of 0.2% chlorhexidine mouthwash in reducing gingivitis and stains

Abstract

Aim or Purpose: To assess if a 0.2% chlorhexidine (CHX) mouthwash (MW) with reducing staining technology (Test) could reduce plaque, gingivitis, stains when compared to a commercially-available mouthwash containing 0.2%CHX (Positive Control) and a fluoride mouthwash (Negative Control) in 4-week study. Materials and Methods: The clinical protocol was approved by IRB. The study had a randomized, double-blind, parallel-group design. Subjects with initial Quigley-Hein(Q-H) plaque index of at least 1.5 and initial Loe-Silness(L-S) gingival index of at least 1.0 participated in the study.2 and 4week assessments were performed using Q-H plaque, L-S gingivitis and Lobene stain indexes. Results: 150 subjects enrolled and 145 completed the study. At baseline, there were no statistically significant differences in plaque, gingivitis and stains.At 2 weeks, Test and Positive Control Groups respectively provided statistically significant greater reductions in plaque (19.9%, 20.5%) and gingivitis (44.9%, 46.4%) than Negative Control Group. At 4 weeks, Test and Positive Control Groups respectively provided statistically significant greater reductions in plaque (26.2%, 28.4%) and gingivitis (73.9%, 75.4%) than Negative Control Group.At 2 and 4 weeks, there were no statistically significant differences in plaque and gingivitis between Test and Positive Control Groups.In addition, Test Group showed statistically significantly less stains in Lobene Composite Score than Positive Control Group at 2 and 4 weeks (32.2%, 34.2%). Test Group and Positive Control Groups showed more stains than the Negative Control Group at 2 and 4weeks. Conclusions: The new 0.2% chlorhexidine mouthwash with reducing staining technology showed statistically significant greater reductions in plaque and gingivitis than a fluoride mouthwash and less.