Study design and sample
allergy, alveolitis, infections, pain, Nolla - Stage
ADVERSE REACTIONS, SYSTEMIC DISEASE, ALLERGY, ALVEOLITIS, INFECTIONS, TOOTH IMPACTION, COMPLICATIONS
After the project was written, (following the full set of ethical principles that govern research on human beings present in the Declaration of Helsinki in 1975, revised in 2013), it was submitted to the research ethics committee of the State University of Vale do Acaraú (UVA), to obtain final approval; Opinion Number 4,351,198. The research was also registered in the Brazilian Clinical Trials Registry (REBEC) at www.ensaiosclinicos.gov.br with the identifier RBR-9k64p2q.A randomized triple-blind, split-mouth clinical trial was conducted over a 12-month period (September 2020 to September 2021) at the oral surgery clinic of the Federal University of Ceará - Sobral Campus following all of the stipulated biosecurity protocols of the Federal University of Ceará. This protocol included the use of face shields, N95 masks, and surgical pajamas. The authors followed the guideline Consort.Patients aged from 18 to 30 years were selected without regard to gender. For eligibility, it was necessary that the patient presented a clear indication for removal of both lower third molars, and also that both molars be in similar positions according to the Winter (1926) and Pell & Gregory (1933) classifications, and with at least 2/3 of the molar roots having been formed (Nolla - Stage 8).Participants were excluded from the research for the following criteria: presence of any systemic disease, use of any drug that might interfere with the research data, any allergy or history of adverse reactions to any drug used in the research, the presence of pathologies associated with the lower third molars, or presenting the habits of smoking or consuming alcohol. In addition to these initial criteria: patients who did not follow medication or post-surgical recommendations correctly, did not adequately attend return visits, or presented post-surgical complications (such as alveolitis) were excluded from the sample. However, the excluded patients of this study received proper surgical treatment of third molars following an intention-to-treat approach. The relevance of the split-mouth clinical trial is that the pain experience is compared in the same patient.In the first consultation, data referring to patient age, sex, and medical and dental history were collected. After explaining the risks and benefits to the potential research participants, those who chose to participate signed an Informed Consent Form (ICF). After data collection and the initial conversations, clinical and radiographic examinations were performed to assess the positions of the third molars, extent of root formation, and tooth impaction. Once the patient selection process was completed, the surgical phase began, with a minimum of 30 days between surgeries on the same patient. We emphasize that all patients were evaluated for active infections, or use of antibiotics, anti-inflammatory drugs, or analgesics for at least 30 days before the procedure. In addition, all patients received the same written post-surgical recommendations, and the same drug therapies at the end of each procedure.