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NCT Number: NCT07614932

Arthroscopic Lysis and Lavage With and Without Intra-articular Injection of Hyaluronic Acid in Patients With DDwoR in TMJ

The study aims to assess the outcomes of arthroscopic lysis and lavage procedure with and without single intra-articular injection of hyaluronic acid in managing patients with anterior disc displacement without reduction.

The research question that this study will answer is:

Does arthroscopic lysis and lavage combined with hyaluronic acid provide better outcomes in terms of pain intensity and maximum mouth opening compared to arthroscopic lysis and lavage alone?

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Key information

Age range

18 year and older

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

  • Adults above 18 years old.
  • Diagnosis of Disc Displacement Without Reduction (DDWOR) with limited mouth : eitherunilateral or bilateral based on the DC/TMD and confirmed with MRI
  • History of unsuccessful conservative treatment such as physical therapy, occlusal splints,or medications (e.g., NSAIDs, muscle relaxants) for at least 3 months.
  • Patients must sign the informed consent, understand the study procedures and potential risks, accept to volunteer in the study and be available to attend the follow-up visits.

Exclusion criteria

  • Degenerative Temporomandibular Joint Disorders (e.g., osteoarthritis, rheumatoid arthritis).
  • History of prior TMJ surgery (e.g., joint replacement, previous arthroscopy).
  • Severe Systemic Conditions (e.g., cardiovascular disease, autoimmune disorders, uncontrolled diabetes).
  • Active joint infection, acute inflammation, or presence of any condition that may increase the risk of complications from arthroscopic surgery or injections (e.g., local infection, uncontrolled bleeding disorders).
  • Pregnancy or Breastfeeding.
  • Patients with severe Psychological Conditions (e.g., severe depression, psychosis, myofascial pain disorder) or dental related pain will be identified at the initial assessment and referred for appropriate psychological, behavioural, or dental management prior to inclusion in the study.

Treatment and study plan

Arthroscopic lysis and lavage

Procedure

Arthroscopic lysis and lavage without intra-articular hyaluronic acid injection

arthroscopic lysis and lavage with intra-articular injection of hyaluronic acid

Procedure

Arthroscopic lysis and lavage followed by intra-articular injection of hyaluronic acid

Primary outcomes

  1. Pain intensity

    Time frame: baseline enrollment, preoperatively on day of surgery, Week 1, Month 1, Month 3, and Month 6 after intervention

    Pain intensity will be assessed using the Visual Analog Scale (VAS) ranging from 0 to 10 , where 10 indicates no pain and 10 indicates worst pain

Secondary outcomes

  1. Maximum mouth opening

    Time frame: baseline enrollment, preoperatively on day of the surgery, week 1, Month 1, Month 3, and Month 6 after intervention

    Maximum mouth opening will be measured as the distance between the upper and lower incisors using a digital caliper and recorded in millimeters

Study contacts

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

Eshraq Ahmed ElMetwally

CONTACT

[email protected]

+201287472001

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Assessment of Arthroscopic Lysis and Lavage With And Without Intra-Articular Injection of Hyaluronic Acid in the Management of Patients With Disc Displacement Without Reduction: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 29, 2026
Registry last updated
May 29, 2026

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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