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临床试验/NCT06068959
NCT06068959已完成不适用

Effect of Photobiomodulation With LED Cluster on Pain and Mandibular and Cervical Mobility in Patients With Temporomandibular Dysfunction: Clinical, Randomized, Controlled and Blind Study

University of Nove de Julho1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年2月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
1
主要终点
Pain Baseline

研究概览

简要总结

These studies aim to validate the effects of photobiomodulation using clusters of 850nm LEDs (infrared) and 630nm LEDs (red); in pain and cervical and mandibular mobility in patients with TMD. It is a randomized, controlled, and blind clinical trial, which will consist of n= 36, of both genders, with ages ranging from 18 to 45 years, divided into 2 groups: Group 1 Red and infrared LED cluster, Group 2 placebo. The areas where they will receive photobiomodulation will be the TMJ area, masseter muscles, temporal muscles, scalenes, and trapezius. 6 non-consecutive sessions will be performed over 2 weeks. Diagnostic Criteria for Temporomandibular Disorders - DC/TMD will be used to determine TMD and validate participants. To validate the mandibular range of motion (ADM) a pachymeter will be used and for the cervical ADM a goniometer (fleximeter). The pain will be validated using the visual analog scale-VAS. All participants will be evaluated after the first therapeutic intervention, and again at the end, following the same validation procedures used initially.

详细描述

The term temporomandibular disorders (TMD), according to the American American Dental Association (ADA), refers to a group of disorders characterized by pain in the temporomandibular joint (TMD) in the periauricular area or in the masticatory muscles, in addition to TMD sounds during jaw function and deviation or restriction of jaw movements. Its multifactorial etiology is related to a heterogeneous group of functional, structural, and psychological factors, making it difficult to identify the association between a single etiological factor and the signs and symptoms of TMD. As a treatment option, it hasphotobiomodulation, using different light sources, alone or in combination. These studies aim to validate the effects of photobiomodulation using clusters of 850nm LEDs (infrared) and 630nm LEDs (red); in pain and cervical and mandibular mobility in patients with TMD. It is a randomized, controlled, and blind clinical trial, which will consist of n= 36, of both genders, with ages ranging from 18 to 45 years, divided into 2 groups: Group 1 Red and infrared LED cluster, Group 2 placebo. The areas where they will receive photobiomodulation will be the TMJ area, masseter muscles, temporal muscles, scalenes, and trapezius. 6 non-consecutive sessions will be performed over 2 weeks. Diagnostic Criteria for Temporomandibular Disorders - DC/TMD will be used to determine TMD and validate participants. To validate the mandibular range of motion (ADM) a pachymeter will be used and for the cervical ADM a goniometer (fleximeter). The pain will be validated using the visual analog scale-VAS. All participants will be evaluated after the first therapeutic intervention, and again at the end, following the same validation procedures used initially.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •present TMD according Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) Axis I
  • •have all permanent teeth

排除标准

  • •be undergoing orthodontic treatment
  • •be undergoing other treatment for TMD
  • •present dental caries or gingival disease.
  • •Initiate or use any type of medication during the phases of the study
  • •comorbidity

研究组 & 干预措施

Placebo Photobiomodulation

Placebo Comparator

Placebo Photobiomodulation with the equipment turned off

干预措施: Placebo (Device)

Photobiomodulation

Experimental

Photobiomodulation using a LED cluster

干预措施: Photobiomodulation using LED (Device)

结局指标

主要结局

Pain Baseline

时间窗: Before an intervention

Evaluation of Pain using visual analogic scale in centimeters (0-10cm)

Final Pain

时间窗: 2 weeks after treatment

Evaluation of Pain using visual analogic scale in centimeters (0-10cm)

次要结局

  • Final Mandibular mobility(2 weeks after intervention)
  • Final Cervical spine mobility(2 weeks after intervention)
  • Mandibular mobility baseline(Before an intervention)
  • Cervical spine mobility baseline(Before an intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anna Carolina Ratto Tempestini Horliana

Principal investigator

University of Nove de Julho

研究点 (1)

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