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

NCT07614932 — Not applicable, Not yet recruiting, 52 participants, Cairo University

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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

RegistryNCT07614932
StatusNot yet recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment52 (Estimated)
SponsorCairo University (Other)
ConditionsTMJ Disc Disorder, Temporomandibular Joint Disc Displacement, Without Reduction, TMD/Orofacial Pain, Temporomandibular Disorder, TMJ Closed Lock
InterventionsArthroscopic lysis and lavage, arthroscopic lysis and lavage with intra-articular injection of hyaluronic acid (Procedure)
Datesstart 2026-05-01 (estimated), primary completion 2027-01-01 (estimated), completion 2027-01-01 (estimated), first posted 2026-05-29, last updated 2026-05-29
Locations1 site in Egypt

Related Papers Related Patents Related Grants Related Experts
All trials for TMJ Disc Disorder All trials for Temporomandibular Joint Disc Displacement, Without Reduction All trials of Arthroscopic lysis and lavage All trials of arthroscopic lysis and lavage with intra-articular injection of hyaluronic acid

-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?

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
Arthroscopic lysis and lavageActive comparatorProcedure: Arthroscopic lysis and lavage
Arthroscopic lysis and lavage with single intra-articular hyaluronic acid injectionExperimentalProcedure: arthroscopic lysis and lavage with intra-articular injection of hyaluronic acid
  • 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

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

FacilityCityCountryStatus
Faculty of Dentistry, Cairo UniversityCairoEgypt

+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; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151. PMID 24482784