J Garima, E Wadhwani, N Tewari, K Bekes, V Mathur, M Rahul
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The data was extracted and analysed, and their quality was assessed using the Cochrane Risk of Bias (RoB 2.0) tool.</p><p><strong>Results: </strong>A total of 39 RCTs were included. The majority of them were in the domain of Therapeutics-General followed by Therapeutics-Molar and Therapeutics-Incisor. More than half of the RCTs followed the CONSORT guidelines and displayed methodological variability. Amongst the included studies, 20 had low risk of bias (ROB), 13 had some concerns, and six studies had high ROB.</p><p><strong>Conclusions: </strong>This study may serve as a roadmap for MIH researchers for identifying the areas where new, high-quality trials are urgently needed, such as pulp therapy, prognostic severity, extraction of MIH affected molars, caries risk, oral health related quality of life, health economics evaluation, and complications. The researchers may also take note of methodological characteristics of existing RCTs and improve future trials. 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引用次数: 0
摘要
目的:磨牙-切牙低矿化(MIH)作为一种口腔健康状况在过去的25年里已经为人所知。一些随机临床试验(rct)已经进行了有关不同表现的MIH的管理。本研究旨在识别这些随机对照试验,将它们分布在域和子域,描述它们的特征,并分析它们的质量。方法:根据研究问题的关键要素制定系统的检索策略,并于2025年2月28日在PubMed、EMBASE、Scopus、Cochrane、Web of Sciences和LILACS 6个数据库上进行电子检索。任何与MIH相关的随机对照试验都被纳入。对资料进行提取和分析,并使用Cochrane风险偏倚(RoB 2.0)工具评估其质量。结果:共纳入39项rct。其中大多数是在治疗学-一般领域,其次是治疗学-臼齿和治疗学-门牙。超过一半的随机对照试验遵循CONSORT指南,并显示出方法的可变性。在纳入的研究中,20项研究具有低偏倚风险(ROB), 13项研究存在一定的顾虑,6项研究具有高偏倚风险。结论:本研究可以作为MIH研究人员的路线图,以确定迫切需要新的高质量试验的领域,如牙髓治疗、预后严重程度、MIH影响磨牙的拔除、龋齿风险、口腔健康相关的生活质量、健康经济学评估和并发症。研究人员还可以注意现有随机对照试验的方法学特征,并改进未来的试验。此外,该研究可以帮助确定准备进行系统审查或更新的领域,最终指导以证据为基础的临床实践指南。
Evidence mapping and quality assessment of randomised trials related to molar incisor hypomineralisation.
Objectives: Molar-incisor hypomineralisation (MIH) as an oral health condition has been known for the past 25 years. Several randomised clinical trials (RCTs) have been conducted pertaining to the management of different manifestations of MIH. This study aims to identify these RCTs, distribute them in domains and subdomains, describe their characteristics, and analyse their quality.
Methods: The systematic search strategy was formulated based on the key elements of the research question and performed electronically on six databases: PubMed, EMBASE, Scopus, Cochrane, Web of Sciences, and LILACS on February 28, 2025. Any study that is a RCT related to any domain of MIH was included. The data was extracted and analysed, and their quality was assessed using the Cochrane Risk of Bias (RoB 2.0) tool.
Results: A total of 39 RCTs were included. The majority of them were in the domain of Therapeutics-General followed by Therapeutics-Molar and Therapeutics-Incisor. More than half of the RCTs followed the CONSORT guidelines and displayed methodological variability. Amongst the included studies, 20 had low risk of bias (ROB), 13 had some concerns, and six studies had high ROB.
Conclusions: This study may serve as a roadmap for MIH researchers for identifying the areas where new, high-quality trials are urgently needed, such as pulp therapy, prognostic severity, extraction of MIH affected molars, caries risk, oral health related quality of life, health economics evaluation, and complications. The researchers may also take note of methodological characteristics of existing RCTs and improve future trials. Moreover, the study can help identify areas ready for systematic reviews or their updates, ultimately guiding evidence-based clinical practice guidelines.