Garima J, Wadhwani E, Tewari N, Bekes K, Mathur V, Rahul M
All India Institute of Medical Sciences, New Delhi, India.
Medical University of Vienna, Vienna, Austria.
Eur Arch Paediatr Dent. 2025 Aug 24. doi: 10.1007/s40368-025-01100-y.
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.
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.
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.
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.
磨牙-切牙矿化不全（MIH）作为一种口腔健康状况，在过去25年中已为人所知。针对MIH不同表现的管理已开展了多项随机临床试验（RCT）。本研究旨在识别这些RCT，将它们分配到各个领域和子领域，描述其特征，并分析其质量。
基于研究问题的关键要素制定系统检索策略，并于2025年2月28日在六个数据库上进行电子检索：PubMed、EMBASE、Scopus、Cochrane、科学网和拉丁美洲及加勒比卫生科学数据库。纳入任何与MIH任何领域相关的RCT研究。提取并分析数据，并使用Cochrane偏倚风险（RoB 2.0）工具评估其质量。
共纳入39项RCT。其中大多数属于治疗-一般领域，其次是治疗-磨牙和治疗-切牙领域。超过一半的RCT遵循CONSORT指南，并显示出方法学上的变异性。在所纳入的研究中，20项偏倚风险低，13项存在一些问题，6项研究偏倚风险高。
本研究可为MIH研究人员提供一个路线图，以确定迫切需要开展新的高质量试验的领域，如牙髓治疗、预后严重程度、MIH受累磨牙的拔除、龋齿风险、口腔健康相关生活质量、卫生经济学评估和并发症。研究人员还可以注意现有RCT的方法学特征，并改进未来的试验。此外，该研究有助于确定适合进行系统评价或更新的领域，最终指导循证临床实践指南。
