Selective outcome reporting concerning antibiotics and third molar surgery.

IF 3.1 2区 医学 Q1 DENTISTRY, ORAL SURGERY & MEDICINE Clinical Oral Investigations Pub Date : 2025-01-03 DOI:10.1007/s00784-024-06130-2
Thalita Guarda Fagoni, Vanessa Cristina Rafalovich, Mariana Aparecida Brozoski, Maria Cristina Zindel Deboni, Natacha Kalline de Oliveira
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Abstract

Objectives: 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.

Materials and methods: 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.

Results: 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.

Conclusions: 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.

Clinical relevance: 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.

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关于抗生素和第三磨牙手术的选择性结果报告。
研究目的本研究评估了第三磨牙手术中抗生素使用临床试验中的选择性结果报告(SOR)。它探讨了选择性结果报告如何使结果产生偏差并影响系统性综述,从而可能导致对干预效果的误读:在 "ClinicalTrials.gov"、"巴西临床试验登记处"、"国际临床试验登记平台 "和 "欧盟临床试验登记处 "上使用 "第三磨牙 "和 "抗生素 "这两个词进行搜索,搜索时间截至 2024 年 12 月。两名独立研究人员筛选出符合条件的临床试验。从登记的方案和相应的出版物中提取数据。使用既定标准对差异进行分析,并使用 "偏倚风险 "2(Risk of Bias2)对已发表文章的偏倚风险进行评估:结果:87.5%的研究发现方案与发表文章之间存在差异,68.7%的研究结果受到影响。在存在一项或多项差异的研究中,SOR 对结果有重大影响。75%的研究对抗生素治疗后的疼痛进行了评估;其中50%的研究结果显著。只有 31.25% 的研究显示使用抗生素可显著减轻肢体瘫痪或水肿。不同研究的偏倚风险差异很大:结论:选择性报告的比例很高,这说明需要进行透明的研究,以明确抗生素在围手术期的作用。研究人员应遵守最佳临床实践,包括方案注册、样本大小的准确计算和报告的精确性。期刊和审稿人必须将透明度放在首位,以减少偏见并提高研究质量:本研究强调了在第三磨牙手术中使用抗生素的临床试验中 SOR 的影响。临床医生在阅读有 SOR 的随机临床试验证据时应更加谨慎。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Clinical Oral Investigations
Clinical Oral Investigations 医学-牙科与口腔外科
CiteScore
6.30
自引率
5.90%
发文量
484
审稿时长
3 months
期刊介绍: The journal Clinical Oral Investigations is a multidisciplinary, international forum for publication of research from all fields of oral medicine. The journal publishes original scientific articles and invited reviews which provide up-to-date results of basic and clinical studies in oral and maxillofacial science and medicine. The aim is to clarify the relevance of new results to modern practice, for an international readership. Coverage includes maxillofacial and oral surgery, prosthetics and restorative dentistry, operative dentistry, endodontics, periodontology, orthodontics, dental materials science, clinical trials, epidemiology, pedodontics, oral implant, preventive dentistiry, oral pathology, oral basic sciences and more.
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