Placebo-Controlled Clinical Trial of 0.07% CPC Rinse on Induced Gingivitis

Objective: A placebo-controlled clinical trial was conducted to evaluate use of a 0.07% cetylpyridinium chloride rinse on induced (experimental) gingivitis. Methods: After 21-days of supervised oral hygiene and prophylaxis, 57 healthy adults were randomized to one of two groups: 0.07% cetylpryidinium chloride rinse (Crest® Pro-Health™ Night) or placebo. Normal oral hygiene was suspended for 21-days of gingivitis induction, during which, subjects rinsed twice daily for 30-seconds with 20 mL of the assigned rinse. After completion of the 21-day gingivitis induction phase, a prophylaxis was administered and oral hygiene restored, and subjects were monitored through resolution. Clinical response was measured using the modified Papillary Bleeding Index at Day –21, 0 and 21. Results: Mean (SD) age was 30.2 (10.2), and 74% of subjects were female. All completed the 21-day induced gingivitis period and were included in the analysis. Relative to pretreatment, both groups experienced significant (p<0.001) improvement during the initial hygiene phase, as evidenced by 40%+ reductions in mean PBI. Compared to baseline (post-hygiene Day 0), the placebo group was the only one to exhibit a significant increase in PBI (p=0.006). The 0.07% CPC did not differ (p>0.37) from baseline PBI after 21 days without oral hygiene. At Day 21, adjusted mean (SE) PBI was 1.02 (0.05) in the 0.07% CPC group compared to 1.24 (0.05) in placebo, with groups differing significantly (p=0.005). Conclusion: In a 21-day induced gingivitis study, twice daily use of a 0.07% cetylpyridinium chloride rinse prevented significant gingivitis onset relative to baseline and reduced gingivitis relative to placebo control.