Method: A randomized controlled trial was conducted to evaluate the safety and effectiveness of a 0.1% cetylpryidinium chloride (CPC) rinse on gingival bleeding in adults with mild-to-moderate gingivitis. After informed consent, gingivitis/bleeding was measured using the Loe Silness Gingivitis Index, and each subject was randomly assigned to an experimental group or professional care control. The experimental group was dispensed regular hygiene products (anticavity paste and manual brush) plus a 0.1% CPC rinse (20 mL, 30 s, BID), while the control group received a dental prophylaxis plus regular hygiene. Test products were dispensed in blinded kits with labeled usage instructions, daily treatment was unsupervised at-home, and subjects were evaluated biweekly over 6 weeks to assess change in bleeding sites.
Result: The 50 adults (mean age=27.7 years) exhibited considerable diversity with respect to ethnicity and gender. At baseline, groups were balanced on demographics (p>0.2) and bleeding sites (range from 3-27), with an overall mean (SD) of 10.7 (5.7). Relative to baseline, both the rinse group and the professional control exhibited significant (p<0.001) reductions in bleeding beginning at Week 2 and persisting through Week 6. Between-group responses were nearly identical at Week 2. By Week 6, the 0.1% CPC rinse (without prophylaxis) had a mean (SD) of 3.7 (0.75) bleeding sites, approximately 34% lower than professional care control. Both treatments were well-tolerated.
Conclusion: In a general population, gingivitis treatment with a 0.1% cetylpridinium chloride rinse showed significant (p<0.001) reductions in bleeding that were comparable to dental prophylaxis.
Keywords: Antimicrobials, Clinical trials, Gingivitis, Mouthrinses and Periodontium-gingiva