Internal Photobiomodulation For Management Of Temporomandibular Joint Internal Derangement

NCT06763419 | Recruiting

• 1 other identifier: 0828-12/2023
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Temporomandibular Joint Disorders

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

External low level laser therapy

EXPERIMENTAL

Device: External low level laser therapy

Internal low level laser therapy

ACTIVE COMPARATOR

Device: Internal low level laser therapy

Interventions

External low level laser therapy DEVICE

Patients received 8 sessions of external diode laser (635 nm).

External low level laser therapy

Internal low level laser therapy DEVICE

Patients received 8 diode laser (635 nm) sessions applied internally

Internal low level laser therapy

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nourhan M.Aly: lead

Study Sites (1)

Faculty of Dentistry

Alexandria, Egypt

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Officials

• Nermeen Rady, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  PRINCIPAL INVESTIGATOR

• Mariam M Bahgat, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY CHAIR

• Aly Atteya, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  PRINCIPAL INVESTIGATOR

• Hoda MA Abdel-Naby, PhD

  Faculty of Medicine, Alexandria University, Egypt

  STUDY DIRECTOR

Central Study Contacts

Mariam Bahgat, PhD

CONTACT

+20 12 22882107; mariam.amin@alexu.edu.eg

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: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer of Dental Public Health

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 8, 2025
• Study Start: December 25, 2024
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: January 8, 2025

Record last verified: 2025-01

Locations

EG (1)