Effects of Low-Level Laser Therapy on Mouth Opening and Surface Electromyography in Temporomandibular Disorders

Официальное название

Effects of Low-Level Laser Therapy Versus Soft Occlusive Splints on Mouth Opening and Surface Electromyography in Temporomandibular Disorders

Обзор

This is a one year followup study that aims to assess the efficacy of low level laser therapy (LLLT) on pain, mouth opening and masticatory muscle activity in cases of temporomandibular dysfunction (TMD) as compared to soft occlusive splints.

Подробное описание

A prospective, parallel randomized, controlled study will be conducted at the outpatient university clinic. Participant recruitment started following approval from the Ethics Committee .The patients will participate in the study after signing an informed consent form prior to data collection. Per inclusion criteria, subjects included are females less than 30 years of age, diagnosed with unilateral arthrogenous TMD, having complete permanent dentition and showing normal occlusion. Prior to participating in any study-related procedures, participants read and signed the informed consent form approved by the Institutional Review Board. Participants will be divided into three groups; three groups: LLLT (Group A); soft occlusive splint therapy OST (Group B); waitlist as controls (Group C).

Outcome measures: TMJ opening index (TOI), VAS, sEMG. Participants were not given information on which treatment they were receiving; they were only told that they could receive one of two different treatment techniques. Sessions were scheduled 3 days a week (every other day) for a total of 10 sessions

Вмешательства

• Другое Low level laser
  940 nm wavelength with 0.2 W output power and 2 J energy applied for 10 seconds with an energy density of 2.5 J/cm2.
• Устройство Soft occlusive splint
  A vacuum-formed soft occlusal splint made from a 2-mm-thick elastic rubber sheets. Participants are instructed to always wear the splint except during mealtimes and oral hygiene.

Первичные конечные точки

• Change in the Temporomandibular joint opening index (TOI): [Срок оценки: baseline (pre-treatment) / after 3 weeks / and after 1 year]

Вторичные конечные точки (2)

• change in surface EMG (sEMG): [Срок оценки: baseline (pre-treatment) / after 3 weeks / and after 1 year]
• Change in Visual Analogue Scale (VAS) [Срок оценки: baseline (pre-treatment) / after 3 weeks / and after 1 year]

Критерии участия

Критерии включения

Females less than 30 years of age, Diagnosed with unilateral myogenous TMD, Having complete permanent dentition Showing normal occlusion

Критерии исключения

Prior experience of Laser therapy, Systemic diseases (rheumatoid arthritis, ankylosing spondylitis, diabetes… etc. History of trauma in the TMJ or cervical regions; Neurological disorders, Muscular diseases; Cervical pain; Bruxism, Pregnancy; Currently on medication (analgesic, anti-inflammatory, muscle relaxants or anti- depressants) Current use of dental prosthetics; Previous orthodontal treatments; or Fixed restorations affecting occlusal surfaces.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Faculty of Physical Therapy — Giza

Идентификаторы

NCT: NCT04831346 · CairoU2020

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗