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NCT Number: NCT06763419

Internal Photobiomodulation For Management Of Temporomandibular Joint Internal Derangement

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).

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Key information

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

External low level laser therapy

Device

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

Internal low level laser therapy

Device

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

Primary outcomes

  1. Pain level assessment using Visual Analogue Scale

    Time frame: 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

  2. Oral health-related quality of life using OHIP-TMD

    Time frame: 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.

  3. Maximum mouth opening evaluation using the Miller index

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mariam Bahgat, PhD

CONTACT

[email protected]

+20 12 22882107

Sponsors and collaborators

Lead sponsor

Nourhan M.Aly

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 8, 2025
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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