Action of two forms of ozone therapy application on clinical and biochemical parameters after wisdom teeth extraction: clinical, triple blind and randomized study

Authors
Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2023
INTERVENTION: The research project will consist of a randomized, triple‐blind, split‐mouth clinical study and will be submitted to the Local Research Ethics Committee, in which all volunteers, thirty‐si Xparticipants of both genders, will sign the free and informed consent form drawn up in accordance with resolution four hundred and sixty‐si Xof two thousand and twelve of the National Health Council. The project in question offers minimal risk to participants. The effectiveness of two experimental ozone therapy protocols will be evaluated on the clinical parameters of pain, edema and trismus after third molar extraction. Each of the patients will have bilateral surgical removals in two sessions, with an interval of twenty days between sessions. Within the same individual, one side will randomly receive an experimental ozone therapy protocol, while the other side will use the protocol used as a control. The test groups will consist of three ozone therapy administration protocols: ozone gas (administration of one milliliter of ozonized gas subperiosteally); ozone oil (administration of si Xhundred milliequivalents of ozonized oil via subperiosteal route); and control (without administration of therapy) administered in the immediate postoperative period, two and seven days. Surgical extraction of third molars with osteotomy, using local anesthetic mepivacaine two per center with one per hundred thousand of adrenaline. The sutures will be performed with four‐zero Silk thread. The same patients from the control group will be part of the experimental group. After all extractions, patients will receive standard postoperative instructions and standard antibiotic therapy (amoxicillin, five hundred milligrams every eight hours for seven days, orally) and for patients declared allergic to penic CONDITION: C23.550.767 Pain, Postoperative; Edema; Trismus PRIMARY OUTCOME: Clinically compare the effectiveness of protocols in controlling postoperative symptoms (pain) using the visual analogue scale (VAS) as a method, as follows: a sheet will be provided with a 10cm straight line on which the patient will be instructed to mark a point between the extremes "no pain" and "unbearable pain SECONDARY OUTCOME: To analyze the concentration of salivary biomarkers indicating tissue inflammation: total protein (PT), acid phosphatase (FA), alkaline phosphatase (FAL), aspartate aminotransferase (AST), alanine aminotransferase (ALT) present in the saliva of patients in each experimental group in each analysis time through biochemical evaluation To evaluate whether ozone therapy is effective in modulating oxidative stress based on the analysis of the biomarker of thiobarbituric acid reactive species (TBARS) INCLUSION CRITERIA: Patients with favorable systemic and local health conditions; be between 16 and 35 years of age; both genders; with indication of tooth extraction of the lower third molars (elements 38 and 48), in position A or B and Pell & Gregory classification I or II, with at least 2/3 of the root formed
Epistemonikos ID: eeb94f20e1fa14dadc0734328ee40987e8dc346a
First added on: Aug 26, 2024