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血管光生物调节治疗儿童颞下颌关节紊乱病的随机、对照、盲法临床试验方案

Vascular photobiomodulation in the treatment of children with temporomandibular disorders: Study protocol for a randomized, controlled, blind, clinical trial.

机构信息

Universidad Católica del Uruguay (UCU), Montevideo, Uruguay.

Post Graduation Program in Biophotonics Applied to Health Sciences, Universidade Nove de Julho, São Paulo, SP, Brazil.

出版信息

Medicine (Baltimore). 2022 Oct 21;101(42):e31228. doi: 10.1097/MD.0000000000031228.

DOI:10.1097/MD.0000000000031228
PMID:36281107
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9592260/
Abstract

BACKGROUND

This study aims to verify if the use of intravascular laser irradiation of blood (ILIB) influences the reduction of pain and increases the range of motion in opening and closing of the mouth in children and adolescents with temporomandibular disorders (TMD).

METHODS

This will be a blind, randomized, and controlled clinical trial, which will be carried out on children between 6 and 12 years of age who enter the Catholic University of Uruguay, Faculty of Health Sciences, Postgraduate School, for treatment. To be included, children must present temporomandibular disorders, based on the diagnostic criteria will be the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). Forty-five participants will be randomized to three groups: Group 1-ILIB with 2 sessions of 20 minutes for 12 weeks (n = 15); Group 2-Placebo laser application with 2 sessions of 20 minutes for 12 weeks (n = 15); Group 3-Control with no treatment (n = 15). Irradiation will be performed by continuous and direct transcutaneous application to the radial artery, by means of a bracelet that inserts the laser beam. The laser to be used is infrared, power 100 mW ± 20%, wavelength 808 nm ± 10 nm, continuous application. RDC/TMD and pain evaluated through a visual analog scale will be the outcome measures.

DISCUSSION

Due to the low level of evidence, new studies are needed on the effect of ILIB in children with TMD.

摘要

背景

本研究旨在验证血管内激光血液辐照(ILIB)的使用是否会影响减轻疼痛,并增加患有颞下颌关节紊乱(TMD)的儿童和青少年张口和闭口的运动范围。

方法

这将是一项盲法、随机、对照的临床试验,将在进入乌拉圭天主教大学健康科学研究生院接受治疗的 6 至 12 岁儿童中进行。为了纳入研究,儿童必须存在颞下颌关节紊乱,根据诊断标准,这些儿童将被诊断为颞下颌关节紊乱研究诊断标准(RDC/TMD)。45 名参与者将被随机分为三组:第 1 组-ILIB,接受 12 周内 2 次每次 20 分钟的治疗(n=15);第 2 组-假激光治疗,接受 12 周内 2 次每次 20 分钟的治疗(n=15);第 3 组-对照组,不进行任何治疗(n=15)。辐照将通过连续和直接经皮应用于桡动脉进行,使用插入激光束的手镯进行。将使用的激光为红外光,功率为 100mW±20%,波长为 808nm±10nm,连续应用。RDC/TMD 和通过视觉模拟量表评估的疼痛将作为结果测量指标。

讨论

由于证据水平较低,需要对 ILIB 在患有 TMD 的儿童中的作用进行新的研究。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5c91/9592260/5f32c2bfcb77/medi-101-e31228-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5c91/9592260/5f32c2bfcb77/medi-101-e31228-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5c91/9592260/5f32c2bfcb77/medi-101-e31228-g001.jpg

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