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

NCT07614932 | Not Yet Recruiting

• 1 other identifier: Arthroscopic Lysis and Lavage
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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?

Conditions

TMJ Disc Disorder; Temporomandibular Joint Disc Displacement, Without Reduction; TMD/Orofacial Pain; Temporomandibular Disorder; TMJ Closed Lock

Keywords

TMJ arthroscopy; TMJ arthroscopic lysis and lavage; Anterior Disc Displacement without reduction

Outcome Measures

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

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

Secondary Outcomes (1)

• Maximum mouth opening

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

Study Arms (2)

Arthroscopic lysis and lavage

ACTIVE COMPARATOR

Procedure: Arthroscopic lysis and lavage

Arthroscopic lysis and lavage with single intra-articular hyaluronic acid injection

EXPERIMENTAL

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

Interventions

Arthroscopic lysis and lavage PROCEDURE

Arthroscopic lysis and lavage without intra-articular hyaluronic acid injection

Arthroscopic lysis and lavage

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

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

Arthroscopic lysis and lavage with single intra-articular hyaluronic acid injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Egypt

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Therapeutic Irrigation

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Investigative Techniques

Central Study Contacts

Eshraq Ahmed ElMetwally

CONTACT

+201287472001; eshraq.elmetwally@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: 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

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: May 29, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)