University of Split School of Medicine, Šoltanska 2, Split, 21000, Croatia.
J Comp Eff Res. 2023 Aug;12(8):e230058. doi: 10.57264/cer-2023-0058. Epub 2023 Jul 7.
To evaluate the completeness of the description of nonsurgical periodontal therapy interventions in clinical trials registered in ClinicalTrials.gov and correspondence of registered information for trial participants and outcome measures with published articles. We retrieved data from ClinicalTrials.gov and corresponding publications. The completeness of intervention reporting was assessed using the Template for Intervention Description and Replication (TIDieR) checklist for oral hygiene instructions (OHI), professional mechanical plaque removal (PMPR), and subgingival instrumentation, antiseptics and antibiotics. The completeness of registration of trial protocol information was assessed according to the WHO Trial Registration DataSet for participant information (enrollment, sample size calculation, age, gender, condition) and primary/secondary outcome measures. 79 included trials involved OHI (n = 38 trials, 48.1%), PMPR (n = 19, 24.1%), antiseptics (n = 11, 12.7%), or antibiotics (n = 11, 12.7%). There was a great variety in the terms used to describe these interventions. Most of the analyzed trials (93.7%) were completed and did not provide any data on study phase (74.7%). The description of intervention in the registry in ClinicalTrials.gov was inadequate for all analyzed interventions, with description inconsistencies in matching publications. There were also discrepancies in registered and published outcomes: for 39 trials with published results, 18 had different registered and reported primary outcomes, and 29 different registered and reported secondary outcomes. The completeness of the description of nonsurgical therapy of periodontitis in clinical trials is unsatisfactory, reducing the quality of translation of the new evidence and procedures into clinical practice. Significant discrepancy in registered and reported trial outcomes calls into question the validity of reported results and relevance for practice.
评价 ClinicalTrials.gov 注册的临床研究中非手术牙周治疗干预措施描述的完整性,以及注册信息与发表文章中试验参与者和结局指标的一致性。我们从 ClinicalTrials.gov 检索数据和相应的出版物。使用口腔卫生指导(OHI)、专业机械性牙菌斑清除(PMPR)和牙周袋器械、防腐剂和抗生素的 TIDieR 清单评估干预措施报告的完整性。根据 WHO 临床试验注册数据集中的试验方案信息(纳入、样本量计算、年龄、性别、疾病)和主要/次要结局指标评估试验方案信息注册的完整性。纳入的 79 项研究涉及 OHI(n=38 项,48.1%)、PMPR(n=19 项,24.1%)、防腐剂(n=11 项,12.7%)或抗生素(n=11 项,12.7%)。用于描述这些干预措施的术语种类繁多。大多数分析的试验(93.7%)已经完成,并且没有提供任何关于研究阶段(74.7%)的数据。ClinicalTrials.gov 注册库中对干预措施的描述对于所有分析的干预措施都不充分,与出版物的匹配描述不一致。注册和发表的结局也存在差异:对于 39 项有发表结果的试验,18 项有不同的注册和报告的主要结局,29 项有不同的注册和报告的次要结局。牙周炎非手术治疗临床试验中描述的完整性不令人满意,降低了新证据和程序转化为临床实践的质量。注册和报告的试验结局存在显著差异,质疑了报告结果的有效性和对实践的相关性。