Page 86 - Demo

Chapter 584Materials and methodsStudy designThis prospective randomized controlled trial (RCT) was conducted between April and October of 2018. It was reviewed and approved by the Institutional Ethics Committee (METC) of the Academic Medical Centre of Amsterdam in the Netherlands. Study populationOur study included patients who were referred by their dentist for surgical removal of an impacted mandibular third molar at the department of Oral and Maxillofacial Surgery of the Amstelland Hospital, Amstelveen, the Netherlands. After clinical examination, a panoramic radiograph was taken of each patient. Then an independent oral and maxillofacial surgeon decided whether the patient met the inclusion criteria. If the patient met the criteria and gave their signed informed consent to participate, the patient was given the Oral Health Impact Profile-14 (OHIP-14) questionnaire with instructions. Inclusion and exclusion criteriaThis study included only native Dutch speakers who were referred for surgical removal of one impacted mandibular third molar. Other inclusion criteria were age of ≥18 years, American Society of Anesthesiology (ASA) score of 1 (i.e., no systemic diseases or medical conditions), no discernible active pathology associated with the third molars, no acute pericoronitis, and no periodontal disease. Exclusion criteria were allergy to ibuprofen or iodine, smoking habit, presence of systemic disease, history of recent and/or symptomatic peptic ulcer, anti-platelet or anticoagulant therapy, pregnancy or lactating, recent local infection within 15 days prior to surgery, previous radiation therapy to the maxillofacial region, local pathology (e.g., cysts or tumor) associated with the third molars, and lack of consent to the procedure or the study.Sample SizeFor sample size calculations, we performed an a priori power analysis using G*Power 3.1.9.4 [19]. Using an independent-samples t-test, an alpha of 5%, a beta of 15%, one-tailed testing, and an effect size of 0.6, we determined that we needed a sample size of 41 patients per group.