Filme orodispersível de lidocaína em anestesia palatina: ensaio clínico randomizado, controlado e cego

Abstract

Palatine nerve blocks used in connective tissue graft surgery for the treatment of gingival recession are widely used, however, many patients report pain during the procedure. Accordingly, this study evaluated the efficacy and safety of using oraldispersible film containing lidocaine (Lidofilm®) as a pre-anaesthetic in patients equiring palatine nerve anaesthesia for connective tissue graft surgery. Randomized, controlled and blinded clinical trial was conducted with one hundred (n = 100) participants, divided into four experimental groups (n = 25/group): Group 1) no preanaesthetic (naïve); Group 2) oral film containing no lidocaine (placebo); Group 3) conventional anaesthetic gel; and Group 4) oral film containing lidocaine. The sociodemographic profile of the participants was described, and the efficacy and comparative tolerability of the experimental pain-relief treatments was evaluated using a visual analogue scale. Statistical analysis was performed considering a significance level of p ≤ 0.05. The sociodemographic characterization of the participants illustrated that it was a balanced sample representative of the clinical profile commonly observed with this type of procedure. Significant differences were found between the treatments in terms of pain scores. Those participants who received treatment with Lidofilm® reported significantly lower levels of pain than in the other groups. There was no difference between the naïve, placebo and conventional anaesthetic gel groups. From a clinical perspective, the reduction in pain observed with the use of Lidofilm® was deemed to be relevant. Lidofilm® was shown to be safe, effective and did not pose any complications during or after treatment and was therefore considered a promising product.