Use of Zolpidem to control dental anxiety in third molar surgery: a controlled, randomized, triple blind clinical study

• Grant number: 21/05223-4
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Start date: September 01, 2021
• End date: August 31, 2022
• Field of knowledge: Health Sciences - Dentistry - Oral and Maxillofacial Surgery
• Principal Investigator: Leonardo Perez Faverani
• Grantee: Victor Perinazzo Sachi
• Host Institution: Faculdade de Odontologia (FOA). Universidade Estadual Paulista (UNESP). Campus de Araçatuba. Araçatuba , SP, Brazil

Abstract

The controlled, randomized, and triple-blind clinical study will aim to evaluate the performance of Zolpidem in the control of dental anxiety in surgeries for extraction of third molars, in comparison to the negative control (placebo) and positive control (Midazolam 7.5 mg ). The medication in question is popularly used by dental surgeons in their clinical routine, in order to obtain conscious sedation and to control the patient's anxiety. However, no study has yet been carried out to evaluate its effectiveness in inducing sedation and promoting the control of anxiety levels. Therefore, three means of evaluation (questionnaires, physiological and biochemical analyzes) will be used in order to obtain a concrete result on the modulation of anxiety generated by the desire for the surgical procedure. 30 individuals will be selected, with the indication for extraction of third molars, between 16 and 35 years of age, of both sexes and without the presence of local or systemic changes to be operated by the same surgeon. Patients will be divided into 3 groups of 10 individuals and will receive medication 30 minutes before the procedure, according to the group they belong to 1 - Placebo (COM); 2 - Midazolam (MID), and 3 - Zolpidem (ZOL). Before medication and after surgery, the patient will answer a questionnaire containing three scales for assessing the level of anxiety (Corah, MDAS and HAD). Saliva collection will take place during the trans and 30-minute postoperative period and the collected samples will be used to assess the level of cortisol and ±-amylase. Other data to be collected in the pre, trans and postoperative periods will be heart rate (HR), blood pressure (BP), and blood oxygen saturation (SpO2), for the patient's physiological analysis. All data will be submitted to the normality curve for choosing the best statistical test, considering P <0.05. (AU)