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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?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arthroscopic lysis and lavage | Active Comparator |
| |
| Arthroscopic lysis and lavage with single intra-articular hyaluronic acid injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arthroscopic lysis and lavage | Procedure | Arthroscopic lysis and lavage without intra-articular hyaluronic acid injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline enrollment, preoperatively on day of the surgery, week 1, Month 1, Month 3, and Month 6 after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eshraq Ahmed ElMetwally | Contact | +201287472001 | eshraq.elmetwally@dentistry.cu.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Cairo University | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38601255 | Background | 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. | |
| 32609918 |
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Participants are randomized into two separate groups and each participant receives only one intervention throughout the study:
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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.
| arthroscopic lysis and lavage with intra-articular injection of hyaluronic acid | Procedure | Arthroscopic lysis and lavage followed by intra-articular injection of hyaluronic acid |
|
| 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. |
| 24482784 | 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. |
| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D007507 | Therapeutic Irrigation |
| ID | Term |
|---|---|
| D006875 | Hydrotherapy |
| D026741 | Physical Therapy Modalities |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D008919 | Investigative Techniques |
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