Fagoni Thalita Guarda, Rafalovich Vanessa Cristina, Brozoski Mariana Aparecida, Deboni Maria Cristina Zindel, de Oliveira Natacha Kalline
Department of Oral and Maxillofacial Surgery, School of Dentistry, University of São Paulo, Av. Prof. Lineu Prestes, 2227 - Cidade Universitária, São Paulo, 05508-000, Brazil.
Clin Oral Investig. 2025 Jan 3;29(1):42. doi: 10.1007/s00784-024-06130-2.
This study evaluates the selective outcome reporting (SOR) in clinical trials on antibiotic use in third molar surgeries. It explores how SOR may bias results and affect systematic reviews, potentially leading to misinterpretations of intervention efficacy.
A search was conducted on "ClinicalTrials.gov", "Brazilian Registry of Clinical Trials", "International Clinical Trials Registry Platform" and "European Union Clinical Trials Register" using the terms "third molar" and "antibiotics" up to December 2024. Two independent researchers selected eligible clinical trials. Data were extracted from registered protocols and corresponding publications. Discrepancies were analyzed using established criteria, and the risk of bias of published articles was assessed with Risk of Bias2.
Discrepancies between protocols and publications were found in 87.5% of cases, affecting outcomes in 68.7% of studies. SOR significantly influenced results in studies with one or more discrepancies. 75% of studies assess pain post-antibiotic therapy; of those, 50% found significant results. Only 31,25% of studies showed significant reductions in trismus or edema with antibiotic use. The risk of bias varied significantly across studies.
The high rate of selective reporting stresses the need for transparent studies to clarify the role of antibiotics in the perioperative period. Researchers should adhere to best clinical practices, including protocol registration, accurate sample size calculations, and precision in reporting. Journals and reviewers must prioritize transparency to reduce bias and improve research quality.
This study emphasizes the impact of SOR in clinical trials using antibiotics in third molar surgery. Clinicians should be more cautious in reading evidence based on randomized clinical trials with SORs.
本研究评估第三磨牙手术中抗生素使用的临床试验中的选择性结果报告(SOR)。探讨SOR如何可能使结果产生偏差并影响系统评价,从而可能导致对干预效果的误解。
截至2024年12月,在“ClinicalTrials.gov”、“巴西临床试验注册中心”、“国际临床试验注册平台”和“欧盟临床试验注册库”上使用“第三磨牙”和“抗生素”进行检索。两名独立研究人员选择符合条件的临床试验。数据从注册方案和相应出版物中提取。使用既定标准分析差异,并使用偏倚风险2评估已发表文章的偏倚风险。
87.5%的病例发现方案与出版物之间存在差异,68.7%的研究结果受到影响。SOR在一项或多项存在差异的研究中显著影响结果。75%的研究评估抗生素治疗后的疼痛;其中,50%发现有显著结果。只有31.25%的研究表明使用抗生素可显著减轻牙关紧闭或水肿。不同研究之间的偏倚风险差异显著。
选择性报告的高发生率强调了开展透明研究以阐明抗生素在围手术期作用的必要性。研究人员应遵循最佳临床实践,包括方案注册、准确的样本量计算和报告的精确性。期刊和审稿人必须优先考虑透明度,以减少偏倚并提高研究质量。
本研究强调了SOR在第三磨牙手术中使用抗生素的临床试验中的影响。临床医生在阅读基于存在SOR的随机临床试验的证据时应更加谨慎。