Effect of High-intensity Laser Therapy on Patients With Myogenic Temporomandibular Joint Dysfunction
NCT Number: NCT06495788
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Temporomandibular Joint Dysfunction Syndrome
Interventions: DEVICE: High-intensity laser therapy (HILT)|DEVICE: placebo high-intensity laser therapy
Sponsor: Cairo University
Sex: ALL
Age: ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-12
Completion Date: 2024-12-20

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.

Primary Outcome Measures: 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 Outcome Measures: Limitation of Daily Function Temporomandibular Dysfunction questionnaire (LDF-TMDQ), Arabic version of LDF-TMDQ will be used to assess the limitation of daily function in patients with temporomandibular dysfunction in both groups before and after the treatment program. It consists of 10 items. For each item, the subject chose any one of five levels on a numerical rating scale from no problem at all (0) to extremely difficult (4 points). The total score of the 10 items, ranging from 0-40 points, will be analyzed. Internal consistency of the total scores appeared to be good at 0.78 for the 10 items., within 8 weeks