Use of topical anesthetic before and after third molar removal surgery

Authors
Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2023
INTERVENTION: There will be 48 patients, 24 in each group. IIndividuals will be randomly allocated depending on whether or not they use benzocaine gel, 10 minutes before the surgical procedure and within 7 days post‐operatively (placebo controlled). Experimental group: 24 pacientes que receberão benzocaína em gel, 10 minutes before the surgical procedure, with applications of 0.5 ml, and also with continuous use in the postoperative period (being used once a day, for 7 days). Control group: 24 pacientes que receberão placebo em gel, 10 minutes before the surgical procedure, with applications of 0.5 ml, and also with continuous use in the postoperative period (being used once a day, for 7 days). Triple‐blind masking study, in which patient, operator and statistician will be masked. For all volunteers in both groups, the postoperative rescue medication prescribed will be dipyrone 500mg at intervals of 6 hours, as well as antibiotic therapy applied in cases of local infectious process. Clinical parameters will be evaluated. Clinically, postoperative pain scores will be evaluated in periods 2, 4, 6, 8, 10, 24, 48, 72, 96, 120, 144 hours, as well as the use of rescue medication during the first week will be quantified. postoperative. The measurement of the outcome related to anxiety will be carried out using the HAD Scale ‐ assessment of the level of anxiety and depression. The measurement of the stage related to the scar repair of the alveolus will be carried out using a caliper, in which, in the 24h, 72h and 7 day follow‐ups, two depths will be carried out: bucco‐lingual (d) and mesiodistal (D) of the surgical wound , in order to observe the healing process. Such measurements will be made in triplicate, then obtaining an arithmetic average to which the following formula will be applied, CONDITION: Acute pain; Pain, Postoperative C23.888.592.612 PRIMARY OUTCOME: Evaluate mean differences in clinical parameters related to inflammatory events (pain). Pain will be assessed using the visual analogue scale,in which a reduction in pain is expected in the intervention group compared to the control group. INCLUSION CRITERIA: Healthy individuals (American Society of Anesthesiologists ‐ ASA I); of both sexes; aged between 18 and 35 years; in need of removal of lower third molars; third molars that present, on panoramic radiography, similar patterns of root formation, position and degree of impaction when comparing the right and left sides of each volunteer SECONDARY OUTCOME: To evaluate the impact of topical anesthetic use in reducing patient anxiety before puncture with the local anesthesia needle and evaluate scar repair, as well as the impact on quality of life. The measurement of the outcome related to anxiety will be carried out using the HAD Scale ‐ assessment of the level of anxiety and depression. The measurement of the outcome related to scar repair of the alveolus will be carried out using a caliper, in which, at 24h, 72h and 7‐day follow‐ups, two measurements will be taken: buccolingual (d) and mesiodistal (D) of the surgical wound , in order to observe the healing process. Such measurements will be made in triplicate, then obtaining an arithmetic average to which the following formula will be applied, in order to obtain the area: (A= p. d. D/4). To assess quality of life, each patient will receive a questionnaire to answer: Oral Health Impact Profile (OHIP‐14), which basically focuses on negative effects. Regarding all these outcomes, more favorable scores are expected in the intervention group compared to the control group.
Epistemonikos ID: 440dbda17e1ec6446e7cc3464a620cc6cd2f207a
First added on: Aug 26, 2024