Clinical trial NCT06495788: Effect of High-intensity Laser Therapy on Patients With Myogenic Temporomandibular Joint Dysfunction
Official title: Effect of High-intensity Laser Therapy on Temporalis and Masseter Muscles Activity in Patients With Myogenic Temporomandibular Joint Dysfunction
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Temporomandibular Joint Dysfunction Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-07-11
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be conducted to investigate the effect of high-intensity laser therapy on the temporalis and masseter muscles activity in patients with myogenic temporomandibular joint dysfunction.

Detailed description: Temporomandibular joint dysfunction (TMD) is one of the problems that affect the quality of lifestyle through the presence of pain around the joint radiated in the face, neck, or shoulders muscles and a decrease in function of the temporomandibular joint that leads to difficulty in mastication, swallowing, earaches, dizziness, and hearing problems may sometimes be associated with TMD.

High-intensity laser therapy (HILT) is a laser with a wavelength of 1064 nm and has recently been used in the treatment of musculoskeletal diseases. Its primary effect is the analgesic effect and reactive vasodilation by affecting the cutaneous nerve endings. Another mechanism of action is based on tissue stimulation. This stimulation occurs at the level of cells, vascular tissue, interstitial tissue, and the immune system. It increases regeneration and beta-endorphin release by inducing protein synthesis in synovial fluid, thus exerting analgesic and anti-inflammatory effects.

Since there is a lack of literature studying the effect of HILT on masseter and temporalis muscles activity in patients with myogenic TMD so, this study may provide a baseline for a new technique in rehabilitation intervention in patients with myogenic TMD.

Eligibility criteria: Inclusion Criteria:

* Patients from both gender with unilateral myogenic temporomandibular dysfunction (TMD) with trismus diagnosed and referred from maxillofacial specialist.
* Aged between 20 to 45 years old .
* Visual analogue scale (VAS) score \>3 for unilateral myogenic pain of the temporomandibular joint (TMJ).
* Pain lasting at least 3 months.
* Patients were diagnosed as unilateral myogenic pain.

Exclusion Criteria:

* Previous TMJ surgery.
* History of jaw dislocation.
* History of jaw fracture.
* Previous therapy with occlusal splint.
* Concomitant therapy of bruxism.
* Presence of removable oral prosthesis.
* Metal implants in the skull.
* Presence of hearing aids.
* Malignancy.
* Pregnancy.
* Diabetic patients.
* Hypertensive patients.
* Systemic rheumatologic disease
* Systemic infection.
* Inserted cardiac pacemaker.
* Presence of coagulation disorders.
* Trigeminal neuritis.
* Cognitive dysfunction.
* Bilateral TMD.

Primary outcomes:
measure: Temporalis and masseter muscles activity
timeFrame: within 8 weeks
measure: Pain intensity
timeFrame: within 8 weeks
measure: Range of mouth opening
timeFrame: within 8 weeks
Secondary outcomes:
measure: Limitation of Daily Function Temporomandibular Dysfunction questionnaire (LDF-TMDQ)
timeFrame: within 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Amir Saleh, professor
role: STUDY_CHAIR
affiliation: Cairo University
name: Naglaa Awais, PHD
role: STUDY_DIRECTOR
affiliation: Al-Azhar University
name: Hala Hazzaa, professor
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Yasser Lasheen, PHD
role: STUDY_DIRECTOR
References: