School of Dentistry, Universidade Metropolitana de Santos, Santos, SP, Brazil.
Postgraduation Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, São Paulo, SP, Brazil.
BMJ Open. 2021 Mar 10;11(3):e044653. doi: 10.1136/bmjopen-2020-044653.
Dentin hypersensitivity (DH) is defined as high sensitivity of the vital dentin when exposed to thermal, chemical or tactile stimuli. Two mechanisms are required for the occurrence of DH: (1) the dentin must be exposed and (2) the dentinal tubules must be open and connected to the pulp. Molar-incisor hypomineralisation (MIH) is a qualitative abnormality of a genetic origin that affects tooth enamel and, in most cases, is accompanied by DH. The control of tooth sensitivity is fundamental to the successful treatment of MIH. The aim of the proposed randomised, controlled, clinical trial is to evaluate the effectiveness of different protocols for the control of DH in patients with teeth affected by MIH.
One hundred and forty patients who meet the inclusion criteria will be allocated to four groups. Group 1 will be the control group (placebo). In Group 2, sensitive teeth will be sealed with PermaSeal (Ultradent). In Group 3, sensitive teeth will receive low-level laser (LLL, AsGaAl) at a wavelength of 780 nm (Laser XT Therapy, DMC, São Carlos, Brazil). In Group 4, sensitive teeth will be treated with both LLL and PermaSeal (Ultradent). DH will be evaluated 15 min after the application of the treatments and the patients will be reevaluated 1 week, 1 month, 3 months and 6 months after the treatments. The primary outcome of this study is change in pain/sensitivity, when evaluated through a Visual Analogue Scale, to determine the effectiveness of the proposed treatments, as well as differences among the evaluation times for each proposed treatment.
This protocol has been ethically approved by the local medical ethical committee (protocol number: 4.020.261). Results will be submitted to international peer-reviewed journals and presented at international conferences.
NCT04407702.
牙本质过敏症（DH）被定义为暴露于热、化学或触觉刺激时活髓牙的高度敏感。DH 的发生需要两个机制：（1）牙本质必须暴露；（2）牙本质小管必须开放并与牙髓相通。磨牙-切牙釉质发育不全（MIH）是一种由遗传原因引起的定性异常，影响牙釉质，在大多数情况下，伴有 DH。控制牙齿敏感是 MIH 成功治疗的基础。本研究旨在评估不同方案控制 MIH 患者 DH 的有效性。
将符合纳入标准的 140 名患者分为四组。第 1 组为对照组（安慰剂）。第 2 组，用 PermaSeal（Ultradent）封闭敏感牙齿。第 3 组，用波长为 780nm 的低水平激光（AsGaAl）（Laser XT Therapy，DMC，巴西圣卡洛斯）治疗敏感牙齿。第 4 组，用 LLL 和 PermaSeal（Ultradent）联合治疗敏感牙齿。治疗后 15 分钟评估 DH，治疗后 1 周、1 个月、3 个月和 6 个月对患者进行再评估。本研究的主要结局是通过视觉模拟评分评估疼痛/敏感性的变化，以确定所提出的治疗方法的有效性，以及每种治疗方法的评估时间之间的差异。
该方案已获得当地医学伦理委员会的伦理批准（方案编号：4.020.261）。研究结果将提交给国际同行评议期刊，并在国际会议上发表。
NCT04407702。
