Postgraduate Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, Campus Vergueiro, São Paulo, SP, Brazil.
School of Dentistry, Universidade Nove de Julho, São Paulo, SP, Brazil.
BMJ Open. 2023 Dec 14;13(12):e076226. doi: 10.1136/bmjopen-2023-076226.
Molar incisor hypomineralisation (MIH) is a qualitative defect of enamel development that occurs in the mineralisation phase. MIH affects one or more permanent molars and, occasionally, permanent incisors. The aim of the proposed study is to evaluate the clinical effect of antimicrobial photodynamic therapy (aPDT) on permanent teeth with MIH through decontamination and sensitivity control.
Patients from 8 to 12 years of age with permanent molars will be randomly allocated to three groups. Group 1: selective chemical-mechanical removal of carious dentinal tissue around the walls of the cavity with Papacárie Duo and a curette followed by the application of aPDT and deproteinisation with Papacárie Duo; group 2: selective removal of carious dentinal tissue around the walls of the cavity with a curette, followed by the application of aPDT and deproteinisation with a 5% sodium hypochlorite solution; group 3: selective removal of carious dentinal tissue using a curette. The selected teeth must have a carious lesion in the dentin and posteruptive enamel breakdown on one or more surfaces with an indication for clinical restorative treatment. The teeth will subsequently be restored using a mixed technique with resin-modified glass ionomer cement and bulk-fill composite resin. The data will be submitted to descriptive statistical analysis. Associations with age and sex will be tested using either the χ test or Fisher's exact test. Pearson's correlation coefficients will be calculated to determine the strength of correlations between variables. Comparisons of the microbiological results (colony-forming units) will be performed using analysis of variance and the Kruskal-Wallis test. Kaplan-Meier survival analysis will be performed to assess the performance of the restorations.
This protocol has been approved by the Human Research Ethics Committee of Nove de Julho University (certificate number: 61027522.0.0000.5511/approval date: 23 August 2022). The findings will be published in a peer-reviewed journal.
NCT05443035.
磨牙-切牙牙釉质发育不全（MIH）是一种在矿化阶段发生的釉质发育质量缺陷。MIH 影响一颗或多颗恒牙，偶尔也会影响恒牙切牙。本研究旨在通过去污和控制敏感性来评估抗菌光动力疗法（aPDT）对 MIH 恒牙的临床疗效。
将 8 至 12 岁的恒牙患者随机分配到三组。组 1：用 Papacárie Duo 和牙挺选择性地去除龋坏牙本质组织，然后应用 aPDT 和 Papacárie Duo 脱蛋白；组 2：用牙挺选择性地去除龋坏牙本质组织，然后应用 5%次氯酸钠溶液进行 aPDT 和脱蛋白；组 3：用牙挺选择性地去除龋坏牙本质组织。所选牙齿必须有一个在牙本质中的龋损，并且一个或多个表面有后萌出釉质破裂，需要临床修复治疗。然后，使用混合技术，即用树脂改性玻璃离子水门汀和大颗粒复合树脂进行修复。将对数据进行描述性统计分析。将使用卡方检验或 Fisher 精确检验来检验年龄和性别之间的相关性。Pearson 相关系数将用于确定变量之间的相关性强度。将使用方差分析和 Kruskal-Wallis 检验来比较微生物学结果（菌落形成单位）。Kaplan-Meier 生存分析将用于评估修复体的性能。
本方案已获得 Nove de Julho 大学人类研究伦理委员会的批准（证书编号：61027522.0.0000.5511/批准日期：2022 年 8 月 23 日）。研究结果将发表在同行评议的期刊上。
NCT05443035。
