Internal Photobiomodulation For Management Of Temporomandibular Joint Internal Derangement

Internal Photobiomodulation For Management Of Temporomandibular Joint Internal Derangement: A Randomized Clinical Trial

Aim of the study was to compare the efficacy of internal versus external photobiomodulation (PBM) in the management of patients with TMJ internal derangements (TMJ-ID).

Study Overview

• Status: Recruiting
• Conditions: Temporomandibular Joint Disorders
• Intervention / Treatment: Device: External low level laser therapy; Device: Internal low level laser therapy

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mariam Bahgat, PhD; Phone Number: +20 12 22882107; Email: mariam.amin@alexu.edu.eg

Study Locations

• Egypt
  • Alexandria, Egypt
    • Recruiting
    • Faculty of Dentistry
    • Contact: Mariam Bahgat, PhD; Phone Number: +20 12 22882107; Email: mariam.amin@alexu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Painful click at temporomandibular joint (TMJ) area.
• Pain at the lateral pterygoid muscle.
• Presence of full or nearly full complement of natural teeth with acceptable occlusion

Exclusion Criteria:

• Patients who have radiographic evidence of degenerative conditions of TMJ.
• Patients under current dental or physical therapy that could affect TMD.
• History of recent trauma.
• The presence of systemic diseases (i.e. rheumatoid arthritis, osteoarthritis).
• Pregnant and lactating females.
• Presence of open bite.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: External low level laser therapy	Device: External low level laser therapy; Patients received 8 sessions of external diode laser (635 nm).
Active Comparator: Internal low level laser therapy	Device: Internal low level laser therapy; Patients received 8 diode laser (635 nm) sessions applied internally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain level assessment using Visual Analogue Scale	All patients will be evaluated subjectively through Visual Analogue Scale (VAS) to clinically assess the pain intensity with ratings between 0 for pain-free and 10 for maximum pain	after one month from the last laser session
Oral health-related quality of life using OHIP-TMD	Oral health-related quality of life will be assessed using OHIP-TMD, a 22-item temporomandibular disorder-specific version of the Oral Health Impact Profile (OHIP). Each item in the OHIP-TMDs is scored on a Likert scale, often ranging from: 0 (Never) to 4 (Very often). For each respondent, the scores for all 22 items are summed to create a total score. The total score ranges from 0 to 88, where higher scores indicate a greater negative impact on oral health-related quality of life.	after one month from the last laser session
Maximum mouth opening evaluation using the Miller index	The Miller Index is calculated as a ratio of the observed maximum interincisal distance (distance between the edges of the upper and lower incisors when the mouth is fully open) to the patient's height. This provides a normalized measure of mouth opening relative to body stature. Miller Index= Maximum Interincisal Distance (mm)/Height (cm) Normal Range: A typical Miller Index is around 1.6 to 1.7 mm/cm in healthy individuals. This means that for every centimeter of height, the expected mouth opening is about 1.6 to 1.7 mm. Deviations: Lower than Normal: May indicate restricted mouth opening (e.g., trismus, TMDs, fibrosis, ankylosis).; Higher than Normal: May occur in conditions involving hypermobility.	after one month from the last laser session

Collaborators and Investigators

• Sponsor: Nourhan M.Aly
• Investigators: Principal Investigator: Nermeen Rady, PhD, Faculty of Dentistry, Alexandria University, Egypt; Study Chair: Mariam M Bahgat, PhD, Faculty of Dentistry, Alexandria University, Egypt; Principal Investigator: Aly Atteya, PhD, Faculty of Dentistry, Alexandria University, Egypt; Study Director: Hoda MA Abdel-Naby, PhD, Faculty of Medicine, Alexandria University, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): December 25, 2024
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: December 23, 2024
• First Submitted That Met QC Criteria: January 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 6, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Muscular Diseases; Joint Diseases; Jaw Diseases; Mandibular Diseases; Craniomandibular Disorders; Myofascial Pain Syndromes; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
• Other Study ID Numbers: 0828-12/2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No