A randomized trial of ethyl lauroyl arginate-containing mouthrinse in the control of gingivitis.

Aim: This 4-week, single-centre, randomized, examiner-blind, controlled study investigated the efficacy and safety of 0.15% ethyl lauroyl arginate (LAE)-containing mouthrinse in adults with mild-to-moderate gingivitis.

Material And Methods: Subjects were randomized to use 0.15% LAE-containing mouthrinse or 5% hydroalcohol-negative control twice daily after brushing with standard fluoride toothpaste. Plaque, gingivitis and bleeding were assessed at baseline and Weeks 2 and 4. The oral microflora was analysed at baseline and Week 4.

Results: Eighty-seven subjects were randomized to treatment. The 0.15% LAE-containing mouthrinse was associated with statistically significantly (p < 0.001) greater reductions in mean plaque and gingivitis scores versus the negative control at Week 2 (difference [95% confidence interval]: plaque 0.83 [0.64, 1.02], 29.1%; gingivitis 0.11 [0.07, 0.14], 4.8%) and Week 4 (co-primary endpoints: plaque 1.23 [1.07, 1.39], 42.6%; gingivitis 0.23 [0.19, 0.28], 10.7%). Bleeding-index scores were significantly (p < 0.001) reduced versus the control at Weeks 2 (by 0.04 [0.03, 0.06], 36.3%) and 4 (by 0.06 [0.04, 0.08], 50.9%). No shifts were detected in the oral microflora. There were no treatment-related adverse events.

Conclusions: The 0.15% LAE-containing mouthrinse was well tolerated and significantly reduced plaque, gingivitis and bleeding when used as an adjunct to tooth brushing for 4 weeks.