Effect of High-intensity Laser Therapy on Patients With Myogenic Temporomandibular Joint Dysfunction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-12

Study Completion Date

2024-12-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Temporomandibular Joint Dysfunction Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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High-intensity laser therapy group

Patients will receive pulsed high-intensity laser therapy in addition to conventional treatment

Group Type EXPERIMENTAL

High-intensity laser therapy (HILT)

Intervention Type DEVICE

* Pulsed high-intensity laser therapy (HILT) will be applied 3 sessions per week for 8 weeks with pulsed emission (1064 nm), very high peak power (3 kW), a short duration (120-150 ms), and low frequency (10-40 Hz).The probe is fixed vertically at 90° to the most painful points while the patients sit on a chair and wear safety eyewear.
* Conventional treatment ( 3 days per week for 8 weeks).: in the form of
* Hot pad: It will be used over the temporomandibular joint (TMJ) for 5 minutes at the beginning of each session.
* Ultrasound therapy (US): it will be applied over the TMJ with pulsed intensity of 1.0 W/cm2 at a 1MHz frequency for 5 min/session.
* TENS: one electrode is placed over the TMJ and the other just above the mandibular angle. it will be applied with a low frequency of 50 HZ, tolerable intensity for 15 minutes.
* Exercise therapy: anterior, medial and lateral glide of the mandible. Each glide will be done 10-15 repetitions, 5-6 times in a session, 10 minutes as a total.

placebo high-intensity laser therapy group

Patients will receive placebo high-intensity laser therapy in addition to conventional treatment

Group Type PLACEBO_COMPARATOR

placebo high-intensity laser therapy

Intervention Type DEVICE

The same treatment procedure will be applied in the placebo group as in the experimental group, but the laser device is turned off during applications, in addition to the conventional treatment in the form of hot pad, US, TENS, and exercise therapy.

Interventions

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High-intensity laser therapy (HILT)

* Pulsed high-intensity laser therapy (HILT) will be applied 3 sessions per week for 8 weeks with pulsed emission (1064 nm), very high peak power (3 kW), a short duration (120-150 ms), and low frequency (10-40 Hz).The probe is fixed vertically at 90° to the most painful points while the patients sit on a chair and wear safety eyewear.
* Conventional treatment ( 3 days per week for 8 weeks).: in the form of
* Hot pad: It will be used over the temporomandibular joint (TMJ) for 5 minutes at the beginning of each session.
* Ultrasound therapy (US): it will be applied over the TMJ with pulsed intensity of 1.0 W/cm2 at a 1MHz frequency for 5 min/session.
* TENS: one electrode is placed over the TMJ and the other just above the mandibular angle. it will be applied with a low frequency of 50 HZ, tolerable intensity for 15 minutes.
* Exercise therapy: anterior, medial and lateral glide of the mandible. Each glide will be done 10-15 repetitions, 5-6 times in a session, 10 minutes as a total.

Intervention Type DEVICE

placebo high-intensity laser therapy

The same treatment procedure will be applied in the placebo group as in the experimental group, but the laser device is turned off during applications, in addition to the conventional treatment in the form of hot pad, US, TENS, and exercise therapy.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes