The effect of a dexibuprofen mouth rinse on experimental gingivitis in humans.

The pharmacodynamic properties of ibuprofen are related nearly exclusively to the S(+)enantiomer (dexibuprofen). This study investigated the effect of a 1.5% dexibuprofen mouth rinse in an experimentally induced gingivitis. The trial was a randomized, double-blinded, placebo-controlled, two-period and two-sequence parallel group cross-over study in 24 healthy volunteers aged 21-30 years (16 males, eight females). Customized guards were worn during tooth brushing to prevent any plaque removal from the experimental area (first and second pre-molars and molars in one upper quadrant). After 22 days of plaque accumulation, the mouth rinses (1.5% dexibuprofen and placebo) were administered under supervision three times daily (rinsing for 1 min. with 15 ml) for 8 days. The wash-out time between the two study periods was 14 days. Parameters evaluated at days 0, 7, 14, 22, and 30 were the Löe & Silness gingival index (GI) and the Quigley & Hein plaque index (QHI). Data were tested for treatment, period, and carry-over effects (parametric cross-over analysis). There was no statistically significant difference (p=0.240) in GI between placebo and dexibuprofen. However, the decrease in QHI was significantly greater (p=0.019) with dexibuprofen as compared with the placebo. In the present study, a 1.5% dexibuprofen mouth rinse had no effect on gingivitis whereas an anti-plaque effect was demonstrated.