Mendonça Fernanda L, Regnault Fabiana Giuseppina Di Campli, Di Leone Camilla C L, Grizzo Isabella C, Bisaia Aliny, Fragelli Camila, Oliveira Thais M, Magalhães Ana C, Rios Daniela
Department of Pediatric Dentistry, Orthodontics and Public Health, Bauru School of Dentistry, University of São Paulo, Bauru, Brazil.
Morphology and Children's Clinic Department, Araraquara Dental School, São Paulo State University, Araraquara, Brazil.
JMIR Res Protoc. 2022 Jan 6;11(1):e27843. doi: 10.2196/27843.
The sensitivity of teeth with molar incisor hypomineralization (MIH) can affect children's quality of life and is a challenging problem for dentists. Remineralizing agents such as sodium fluoride varnish seem to reduce the sensitivity of teeth with MIH, but long-term clinical trials with large samples are still needed for more evidence about its effectiveness as a desensitizing agent before its clinical recommendation.
This randomized clinical trial aims to compare three treatment interventions for teeth with MIH and hypersensitivity.
A total of 60 children aged 6-10 years presenting with at least one first permanent molar with sensitivity and no loss of enamel will be randomly assigned to three groups: the control group (sodium fluoride varnish; Duraphat, Colgate); experimental group I (4% titanium tetrafluoride varnish); and experimental group II (a coating resin containing surface prereacted glass-ionomer filler; PRG Barrier Coat, Shofu). The sodium fluoride varnish and 4% titanium tetrafluoride varnish will be applied once per week for 4 consecutive weeks and the PRG Barrier Coat resin will be applied in the first session and the application will be simulated the following 3 weeks to guarantee the blinding of the study. The primary outcome will be sensitivity level measured at different moments (before each material application, immediately after application or simulation, and 1, 2, 4, and 6 months after the last application/simulation) by one examiner using the Wong-Baker FACES Pain Rating Scale, the Schiff Cold Air Sensitivity Scale, and the FLACC (Face, Legs, Activity, Cry, Consolability) scale. As secondary outcomes, parental satisfaction and child self-reported discomfort after the treatment will be measured with a questionnaire prepared by the researcher. The data will undergo statistical analysis and the significance level will be set at 5%.
The project was funded in 2018, and enrollment was completed in November 2019. The recruitment of participants is currently underway and the first results are expected to be submitted for publication in 2022.
If found effective in reducing the patient's sensitivity long term, these agents can be considered as a treatment choice, and the findings will contribute to the development of a treatment protocol for teeth with sensitivity due to MIH.
Brazilian Registry of Clinical Trials Universal Trial Number U1111-1237-6720; https://tinyurl.com/mr4x82k9.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/27843.
患有磨牙切牙矿化不全（MIH）的牙齿敏感性会影响儿童的生活质量，对牙医来说是一个具有挑战性的问题。诸如氟化钠 varnish 等再矿化剂似乎可以降低患有 MIH 的牙齿的敏感性，但在临床推荐之前，仍需要进行大样本的长期临床试验以获取更多关于其作为脱敏剂有效性的证据。
本随机临床试验旨在比较三种针对患有 MIH 和牙齿过敏的治疗干预措施。
总共 60 名 6 - 10 岁的儿童，其至少有一颗第一恒磨牙有敏感性且牙釉质无缺失，将被随机分为三组：对照组（氟化钠 varnish；Duraphat，高露洁）；实验组 I（4% 四氟化钛 varnish）；实验组 II（一种含有表面预反应玻璃离子填料的涂层树脂；PRG 阻隔涂层，松风）。氟化钠 varnish 和 4% 四氟化钛 varnish 将连续 4 周每周应用一次，PRG 阻隔涂层树脂将在第一阶段应用，并在接下来的 3 周模拟应用以确保研究的盲法。主要结局将是由一名检查者在不同时间点（在每种材料应用前、应用或模拟后立即、最后一次应用/模拟后 1、2、4 和 6 个月）使用 Wong - Baker 面部表情疼痛评定量表、希夫冷空气敏感性量表和 FLACC（面部、腿部、活动、哭泣、安慰性）量表测量的敏感性水平。作为次要结局，治疗后父母的满意度和儿童自我报告的不适将通过研究人员编制的问卷进行测量。数据将进行统计分析，显著性水平设定为 5%。
该项目于 2018 年获得资助，2019 年 11 月完成入组。目前正在招募参与者，预计第一批结果将于 2022 年提交发表。
如果发现这些药物在长期降低患者敏感性方面有效，则可将其视为一种治疗选择，并且这些发现将有助于制定针对因 MIH 导致牙齿敏感的治疗方案。
巴西临床试验注册中心通用试验编号 U1111 - 1237 - 6720；https://tinyurl.com/mr4x82k9。
国际注册报告识别码（IRRID）：DERR1 - 10.2196/27843。
