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

NCT06495788 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/004882
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Temporomandibular Joint Dysfunction Syndrome

Outcome Measures

Primary Outcomes (3)

• Temporalis and masseter muscles activity

  The surface electromyography device (sEMG) (MyoTrac Infiniti 2 Channel sEMG w/Rehab Suite \& Continence Suite-T9855; Quebec, Canada) at 60 Hz and Infiniti software will be used to record masseter and temporalis activity before and after the treatment program. patients will be instructed to clench to help the researcher to find the appropriate muscle location by their prominence. Pregelled and self-adhesive electrodes with 3 surface leads (2 recording, 1 reference) will be used. The electrode is placed over the anterosuperior to the angle of the mandible on both sides for recording masseter muscle, while for temporalis muscle, electrodes are placed above a line drawn from upper earline to canthus of the eye with interelectrode distance which is 8mm. sEMG Signal Analysis: Mean, median frequency, SD, root mean square, minimum, maximum, and range of muscle activity (μV) will be calculated.

  within 8 weeks

• Pain intensity

  Visual analogue scale (VAS), a valid and reliable measure of pain intensity will be used to measure pain intensity for all participants in both groups before and after treatment. All participants will be asked to mark their pain level on a 10-cm line that corresponds to their pain intensity on the line between "0", representing "no pain", and "10", representing "the worst pain.

  within 8 weeks

• Range of mouth opening

  Flexible millimeter ruler will be used to measure mouth opening for all participants in both groups before and after the treatment. Mouth opening will be evaluated by asking the patient to open their mouth as wide as possible and measuring the distance between the edges of the frontal incisors with a ruler at the incisal edge of the maxillary central incisor that is the most vertically oriented and measured vertically to the labio-incisal edge of the opposing mandibular incisor to assess the pre-post therapy maximum mouth opening (MMO). Studies reported range has been as wide as 32-62 mm (for both sexes)

  within 8 weeks

Secondary Outcomes (1)

• Limitation of Daily Function Temporomandibular Dysfunction questionnaire (LDF-TMDQ)

  within 8 weeks

Study Arms (2)

High-intensity laser therapy group

EXPERIMENTAL

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

Device: High-intensity laser therapy (HILT)

placebo high-intensity laser therapy group

PLACEBO COMPARATOR

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

Device: placebo high-intensity laser therapy

Interventions

High-intensity laser therapy (HILT) 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.

High-intensity laser therapy group

placebo high-intensity laser therapy 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.

placebo high-intensity laser therapy group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Temporomandibular Joint Dysfunction Syndrome

Condition Hierarchy (Ancestors)

Temporomandibular Joint Disorders; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Myofascial Pain Syndromes; Stomatognathic Diseases

Study Officials

• Amir Saleh, professor

  Cairo University

  STUDY CHAIR

• Naglaa Awais, PHD

  Cairo University

  STUDY DIRECTOR

• Hala Hazzaa, professor

  Al-Azhar University

  STUDY DIRECTOR

• Yasser Lasheen, PHD

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Mohaya Mohamed, PHD

CONTACT

+201065150305; Mohayaahmed88@yahoo.com

Yasser Lasheen, PHD

CONTACT

01005251562; dr_yasser_1977@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 11, 2024
• Study Start: July 12, 2024
• Primary Completion: November 20, 2024
• Study Completion: December 20, 2024
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL