Orodispersible lidocaine film in palatine nerve block: a randomized, controlled and blind clinical trial.

Palatine nerve blocks used in connective tissue graft surgery for the treatment of gingival recession are widely used, however, many patients report pain with the procedure. Accordingly, this study evaluated the efficacy and safety of using oral-dispersible film containing lidocaine (Lidofilm®) as a pre-anaesthetic in patients with a recommendation for anaesthesia of the palatine nerves in connective tissue graft surgery. It was a randomized, controlled and blind clinical trial comprising one hundred (n = 100) participants, divided into four experimental groups (n = 25/group): Group 1) using no pre-anaesthetic (naïve); Group 2) pre-anaesthetic treatment with oral film containing no lidocaine (placebo); Group 3) pre-anaesthetic treatment with conventional anaesthetic gel; and Group 4) pre-anaesthetic treatment with 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. A descriptive statistical analysis and test of comparison between the groups was conducted, assuming a level of significance of p ≤ 0.05. The sociodemographic characterization of the participants (age, sex, weight, height, body mass index, and schooling) 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.