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Recruiting Not applicable

Internal Photobiomodulation For Management Of Temporomandibular Joint Internal Derangement

NCT06763419 · tracked via the Priya Life Science Egypt tracker
Sponsor
Nourhan M.Aly
Phase
Not applicable
Started
2024-12-25
Last updated
2025-01-08

Condition(s) studied

Temporomandibular Joint Disorders

Investigational drug(s) / intervention(s)

External low level laser therapyInternal low level laser therapy

External low level laser therapy: Patients received 8 sessions of external diode laser (635 nm).

Internal low level laser therapy: Patients received 8 diode laser (635 nm) sessions applied internally

Study 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).

Eligibility

Sex
ALL
Min age
20 Years
Max age
40 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Pain level assessment using Visual Analogue Scale — after one month from the last laser session
    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
  • Oral health-related quality of life using OHIP-TMD — after one month from the last laser session
    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.
  • Maximum mouth opening evaluation using the Miller index — after one month from the last laser session
    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.

Trial sites (1)

FacilityCityRegionStatus
Faculty of Dentistry Alexandria Egypt Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06763419 on ClinicalTrials.gov ↗ ← All trials in Egypt