Preemptive Use of Etoricoxib and Dexamethasone: Effect on Early Bone Healing, Inflammatory Response, and Postoperative Parameters After Impacted Lower Third Molar Surgery

36/22

The goal of this clinical trial is to compare preemptive single-dose selective cyclooxygenase 2 (COX-2) inhibitor - etoricoxib and dexamethasone use in systemically healthy patients during the surgical extraction of impacted mandibular third molars. The main questions it aims to answer/evaluate are: * the level of inflammatory and early wound healing mediators in patients' saliva during early postoperative phase * clinical postoperative parameters such as pain, swelling and trismus * patient satisfaction with the treatment * rescue medication consumed during the postoperative period * incidence of adverse events Participants indicated for mandibular third molar surgery will be asked to: * take premedication (etoricoxib or dexamethasone) before surgical extraction * provide saliva samples before and following the surgery at regular check-ups * note the amount of rescue medication taken and pain intensity in different time points * perform clinical measurements of swelling and trismus at regular check-up visits * answer the questions about satisfaction and potential adverse events, if occur Researchers will compare preemptive single-dose etoricoxib, preemptive single-dose dexamethasone, and no premedication in impacted mandibular third molar surgery, to see if there are differences in inflammatory response and early wound healing, as well as in clinical postoperative parameters, patient satisfaction with the treatment and incidence of potential adverse events.

2021-10-11

2022-12-26

2022-12-26

Completed

Early phase I

90

Inclusion Criteria: * Systemically healthy individuals (ASA I by American Society of Anesthesiologists classification); * Age 18-30 years; * Absence of hypersensitivity to any of the medications in the study; * Subjects capable to understand the protocol and sign an informed consent form. Exclusion Criteria: * Systemic disorders; * Individuals in gestation or lactation period; * Radiographic presence of potential cystic or tumorous lesions in the region of the extraction-required IMTM; * Any symptoms or clinical signs of the infection caused by the extraction-required IMTM up to 10 days preoperatively; * Use of NSAIDs or corticosteroids within 10 days before the surgery.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ACTUAL'}}

2023-03-30