Clinical trial NCT04831346: Effects of Low-Level Laser Therapy on Mouth Opening and Surface Electromyography in Temporomandibular Disorders
Official title: Effects of Low-Level Laser Therapy Versus Soft Occlusive Splints on Mouth Opening and Surface Electromyography in Temporomandibular Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Temporomandibular Joint Dysfunction Syndrome
Pain, Face
Keywords: Temporomandibular
Dysfunction
VAS
EMG
Laser
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-04-05
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment A prospective, parallel-group, randomized clinical trial participants will be randomly assigned to the control group or one of the 2 intervention groups. One group received low level laser therapy (gallium arsenide diode ) while the other received the soft occusive splint. The control group was considered as a wait list for laser treatment aand did not recieve any treatment during the intervention period.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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.

Primary outcomes:
measure: Change in the Temporomandibular joint opening index (TOI):
timeFrame: baseline (pre-treatment) / after 3 weeks / and after 1 year
Secondary outcomes:
measure: change in surface EMG (sEMG):
timeFrame: baseline (pre-treatment) / after 3 weeks / and after 1 year
measure: Change in Visual Analogue Scale (VAS)
timeFrame: baseline (pre-treatment) / after 3 weeks / and after 1 year
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
affiliation: Lecturer
name: Tamer Shousha
role: PRINCIPAL_INVESTIGATOR
References: