Temporomandibular Disorder, Temporomandibular Joint Disc Displacement, Without Reduction, TMD/Orofacial Pain, TMJ Closed Lock, TMJ Disc Disorder
Conditions
Keywords
TMJ arthroscopy, TMJ arthroscopic lysis and lavage, Anterior Disc Displacement without reduction
Brief summary
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?
Interventions
PROCEDUREArthroscopic lysis and lavage
Arthroscopic lysis and lavage without intra-articular hyaluronic acid injection
PROCEDUREarthroscopic lysis and lavage with intra-articular injection of hyaluronic acid
Arthroscopic lysis and lavage followed by intra-articular injection of hyaluronic acid
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
This is a double-blinded randomized controlled trial. Participants, outcome assessors, and the statistician will be blinded to treatment allocation. Surgeons performing the procedures cannot be blinded due to the obvious difference in the injectable material.
Intervention model description
Participants are randomized into two separate groups and each participant receives only one intervention throughout the study: 1. Arthroscopic lysis and lavage alone 2. Arthroscopic lysis and lavage + hyaluronic acid injection
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults above 18 years old. 2. Diagnosis of Disc Displacement Without Reduction (DDWOR) with limited mouth : eitherunilateral or bilateral based on the DC/TMD and confirmed with MRI 3. History of unsuccessful conservative treatment such as physical therapy, occlusal splints,or medications (e.g., NSAIDs, muscle relaxants) for at least 3 months. 4. 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
1. Degenerative Temporomandibular Joint Disorders (e.g., osteoarthritis, rheumatoid arthritis). 2. History of prior TMJ surgery (e.g., joint replacement, previous arthroscopy). 3. Severe Systemic Conditions (e.g., cardiovascular disease, autoimmune disorders, uncontrolled diabetes). 4. 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). 5. Pregnancy or Breastfeeding. 6. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | 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
| Measure | Time frame | Description |
|---|---|---|
| Maximum mouth opening | 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 |
Countries
Egypt
Contacts
CONTACTEshraq Ahmed ElMetwally
Outcome results
None listed