The efficacy of Decapinol mouthwash 2 mg/mL in preventing gingivitis.
In vitro studies and early clinical trials have shown promising results for Delmopinol HCl solution as an effective mouth rinse for reducing experimentally induced gingivitis in the absence of mechanical plaque control. The efficacy of Decapinol mouthwash 2 mg/mL (Delmopinol HCl) in preventing gingivitis in a double-blind, randomized clinical study with parallel group design was studied. Forty-seven healthy young adults were randomly assigned to the Delmopinol or placebo groups. After an initial period of four weeks of intensive oral hygiene including bi-weekly professional cleaning of the teeth and oral hygiene instruction, all subjects achieved a low degree of gingivitis or a plaque score close to zero. At baseline, Bleeding on Probing, Modified Gingival Index and Plaque Index were recorded and the teeth were professionally cleaned. All forms of plaque control were then suspended and subjects were supervised in a one-minute rinsing of Decapinol mouthwash 2 mg/mL or placebo twice daily. Measurements of efficacy variables were then repeated after two and three weeks treatment and adverse events were recorded. After the study period of three weeks all previous plaque control measures were resumed. At week four, all subjects were reassessed for the resolution of gingival inflammation and where residual gingival inflammation persisted, appropriate treatment was given. Only mild and short-lasting adverse events were noted for the use of Delmopinol in the study period. However, for all teeth sites measured, significant differences between Delmopinol and placebo groups were found in Bleeding on Probing (p < 0.05) and Plaque Index (p < 0.0005).(ABSTRACT TRUNCATED AT 250 WORDS)