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

ConditionsTMJ Disc DisorderTemporomandibular Joint Disc Displacement, Without ReductionTMD/Orofacial PainTemporomandibular DisorderTMJ Closed Lock
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCairo University

About this trial

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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Arthroscopic lysis and lavage

    Procedure/Surgery

    Arthroscopic lysis and lavage without intra-articular hyaluronic acid injection

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

    Procedure/Surgery

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

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: Arthroscopic lysis and lavageActive comparator 1 intervention
Group B: Arthroscopic lysis and lavage with single intra-articular hyaluronic acid injectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pain intensity

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

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

Secondary outcomes

1

Maximum mouth opening

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: