Menu
Not yet recruiting NCT07614932

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

No phase Interventional TMJ Disc Disorder Temporomandibular Joint Disc Displacement, Without Reduction TMD/Orofacial Pain Temporomandibular Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Arthroscopic lysis and lavage, arthroscopic lysis and lavage with intra-articular injection of hyaluronic acid.
Who it may be relevant to
Registry conditions: TMJ Disc Disorder, Temporomandibular Joint Disc Displacement, Without Reduction, TMD/Orofacial Pain, Temporomandibular Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

  • Procedure Arthroscopic lysis and lavage
    Arthroscopic lysis and lavage without intra-articular hyaluronic acid injection
  • Procedure arthroscopic lysis and lavage with intra-articular injection of hyaluronic acid
    Arthroscopic lysis and lavage followed by intra-articular injection of hyaluronic acid

Primary outcome measures

  • Pain intensity [Time frame: baseline enrollment, preoperatively on day of surgery, Week 1, Month 1, Month 3, and Month 6 after intervention]
Secondary outcome measures (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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Dentistry, Cairo University — Cairo

Publications

  • Lopez JP, Orjuela MP, Gonzalez LV, Peraza-Labrador AJ, Diaz-Baez D. Comparison of the Clinical Effectiveness of Intra-Articular Injection with Different Substances After TMJ Arthroscopy: A Systematic Review and Meta-Analysis. J Maxillofac Oral Surg. 2024 Apr;23(2):261-270. doi: 10.1007/s12663-023-02047-7. Epub 2023 Dec 12. PMID 38601255
  • Castano-Joaqui OG, Cano-Sanchez J, Campo-Trapero J, Munoz-Guerra MF. TMJ arthroscopy with hyaluronic acid: A 12-month randomized clinical trial. Oral Dis. 2021 Mar;27(2):301-311. doi: 10.1111/odi.13524. Epub 2020 Jul 25. PMID 32609918
  • Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF PMID 24482784

Identifiers

NCT: NCT07614932 · Arthroscopic Lysis and Lavage

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗