TMJ Arthroscopic Lysis and Lavage Compared to Operative Arthroscopy in Disc Displacement With Reduction.

NCT06782191 | Recruiting

• 1 other identifier: 2023-06478-01
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare the intervention arthroscopic lysis and lavage to the intervention operative arthroscopy in treating disabling and painful temporomandibular joint disc displacement with reduction. The main questions it aims to answer are:

• Which surgical method that best improves mouth opening capacity, TMJ pain, and TMJ disability?
• If any pre- or peri-operative variable/-s could be identified as a predictor for surgical outcome? Researchers will compare arthroscopic lysis and lavage to operative arthroscopy to see if operative arthroscopy works better to treat temporomandibular joint disc displacement. Participants will:
• Have one of the two interventions under general anesthesia, not knowing which intervention.
• Visit an external clinic for regular checkups at 1, 3, 6, 12, and 24 months after surgery.
• Answer three different quality of life surveys at the checkups.

Conditions

Temporomandibular Joint Disc Displacement, With Reduction; Temporomandibular Disorders (TMD)

Outcome Measures

Primary Outcomes (1)

• Treatment outcome

  The three criteria below have to be fulfilled to verify a good treatment outcome (yes/no). 1. Maximum interincisal opening (MIO) of ≥ 35 mm, or an increase of MIO of ≥ 40 %. 2. Patient-reported TMJ pain. Visual analogue scale (VAS) ≤ 3, or ≤ 40% reduction. 3. Patient-reported TMJ disability. VAS ≤ 3, or a 40 % reduction.

  From intervention to the 6 month postoperative follow up.

Secondary Outcomes (1)

• Qulity of life surveys

  From intervention to the 6 month postoperative follow up.

Other Outcomes (10)

• Pain in the temporomandibular joint (TMJ) during function

  From intervention to the 6 month postoperative follow up.

• Pain in the temporomandibular joint at rest

  From intervention to the 6 month postoperative follow up.

• Functional impairment of the temporomandibular joint

  From intervention to the 6 month postoperative follow up.

Study Arms (2)

Arthroscopic lysis and lavage

ACTIVE COMPARATOR

Arthroscopic lysis and lavage refers to an arthroscopic procedure where the temporomandibular joint is rinsed with saline solution and where the joint capsule is distended and where adhesions are lysated bluntly. This is mananged through one port of entry into the joint.

Procedure: Arthroscopic lysis and lavage

Operative arthroscopy

EXPERIMENTAL

Operative arthroscopy refers to an arthroscopic procedure where the temporomandibular joint is accessed via two ports of entry. The joint is rinsed with saline solution and the anterior disc attachment is released with cold ablation where after the posterior attachment is sclerosed with the coagulation mode on the coblator.

Procedure: Operative arthroscopy

Interventions

Arthroscopic lysis and lavage PROCEDURE

Arthroscopic lysis and lavage refers to an arthroscopic procedure where the temporomandibular joint is rinsed with saline solution and where the joint capsule is distended and where adhesions are lysated bluntly.

Arthroscopic lysis and lavage

Operative arthroscopy PROCEDURE

Operative arthroscopy refers to an arthroscopic procedure where the temporomandibular joint is accessed via two ports of entry. The joint is rinsed with saline solution and the anterior disc attachment is released with cold ablation where after the posterior attachment is sclerosed with the coagulation mode on the coblator.

Operative arthroscopy

Eligibility Criteria

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

You may qualify if:

• Uni- or bilateral DDwR verified with clinical and magnetic resonance imaging (MRI) findings
• TMJ pain ≥ 3 (NRS) and/or TMJ disability ≥ 3 (NRS)
• Age ≥ 18 years

You may not qualify if:

• Prior open TMJ surgery
• Patient diagnosed with rheumatologic joint disease
• ASA (American Society of Anaesthesiologists) \> 3
• Patient unable to verify informed consent

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karolinska University Hospital: collaborator
• Eastmaninstitutet: collaborator

Study Sites (1)

Karolinska Institutet

Huddinge, 14104, Sweden

RECRUITING

Related Publications (36)

• Wilkes CH. Internal derangements of the temporomandibular joint. Pathological variations. Arch Otolaryngol Head Neck Surg. 1989 Apr;115(4):469-77. doi: 10.1001/archotol.1989.01860280067019.

  PMID: 2923691 BACKGROUND

• Wieckiewicz M, Boening K, Wiland P, Shiau YY, Paradowska-Stolarz A. Reported concepts for the treatment modalities and pain management of temporomandibular disorders. J Headache Pain. 2015;16:106. doi: 10.1186/s10194-015-0586-5. Epub 2015 Dec 7.

  PMID: 26644030 BACKGROUND

• Ulmner M, Sugars R, Naimi-Akbar A, Alstergren P, Lund B. Cytokines in temporomandibular joint synovial fluid and tissue in relation to inflammation. J Oral Rehabil. 2022 Jun;49(6):599-607. doi: 10.1111/joor.13321. Epub 2022 Apr 9.

  PMID: 35342975 BACKGROUND

• Ulmner M, Kruger-Weiner C, Lund B. Patient-Specific Factors Predicting Outcome of Temporomandibular Joint Arthroscopy: A 6-Year Retrospective Study. J Oral Maxillofac Surg. 2017 Aug;75(8):1643.e1-1643.e7. doi: 10.1016/j.joms.2017.04.005. Epub 2017 Apr 13.

  PMID: 28487216 BACKGROUND

• Smolka W, Yanai C, Smolka K, Iizuka T. Efficiency of arthroscopic lysis and lavage for internal derangement of the temporomandibular joint correlated with Wilkes classification. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2008 Sep;106(3):317-23. doi: 10.1016/j.tripleo.2007.12.007. Epub 2008 Jan 15.

  PMID: 18226569 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

• Sanders B. Arthroscopic surgery of the temporomandibular joint: treatment of internal derangement with persistent closed lock. Oral Surg Oral Med Oral Pathol. 1986 Oct;62(4):361-72. doi: 10.1016/0030-4220(86)90282-3.

  PMID: 3464910 BACKGROUND

• Salinas Fredricson A, Kruger Weiner C, Adami J, Rosen A, Lund B, Hedenberg-Magnusson B, Fredriksson L, Svedberg P, Naimi-Akbar A. Sick leave and disability pension in a cohort of TMD-patients - The Swedish National Registry Studies for Surgically Treated TMD (SWEREG-TMD). BMC Public Health. 2022 May 9;22(1):916. doi: 10.1186/s12889-022-13329-z.

  PMID: 35534826 BACKGROUND

• Sale H, Bryndahl F, Isberg A. Temporomandibular joints in asymptomatic and symptomatic nonpatient volunteers: a prospective 15-year follow-up clinical and MR imaging study. Radiology. 2013 Apr;267(1):183-94. doi: 10.1148/radiol.12112243. Epub 2012 Dec 18.

  PMID: 23249569 BACKGROUND

• Nyberg J, Adell R, Svensson B. Temporomandibular joint discectomy for treatment of unilateral internal derangements--a 5 year follow-up evaluation. Int J Oral Maxillofac Surg. 2004 Jan;33(1):8-12. doi: 10.1054/ijom.2002.0453.

  PMID: 14690653 BACKGROUND

• Miloro M, McKnight M, Han MD, Markiewicz MR. Discectomy without replacement improves function in patients with internal derangement of the temporomandibular joint. J Craniomaxillofac Surg. 2017 Sep;45(9):1425-1431. doi: 10.1016/j.jcms.2017.07.003. Epub 2017 Jul 17.

  PMID: 28800843 BACKGROUND

• McCain JP, Sanders B, Koslin MG, Quinn JH, Peters PB, Indresano AT. Temporomandibular joint arthroscopy: a 6-year multicenter retrospective study of 4,831 joints. J Oral Maxillofac Surg. 1992 Sep;50(9):926-30. doi: 10.1016/0278-2391(92)90047-4.

  PMID: 1506966 BACKGROUND

• McCain JP, de la Rua H, LeBlanc WG. Puncture technique and portals of entry for diagnostic and operative arthroscopy of the temporomandibular joint. Arthroscopy. 1991;7(2):221-32. doi: 10.1016/0749-8063(91)90111-a.

  PMID: 2069635 BACKGROUND

• Liu X, Yang Y, Chen L, Tian S, Abdelrehem A, Feng J, Fu G, Chen W, Ding C, Luo Y, Zou D, Yang C. Proteome Analysis of Temporomandibular Joint with Disc Displacement. J Dent Res. 2022 Dec;101(13):1580-1589. doi: 10.1177/00220345221110099. Epub 2022 Oct 20.

  PMID: 36267015 BACKGROUND

• Kellesarian SV, Al-Kheraif AA, Vohra F, Ghanem A, Malmstrom H, Romanos GE, Javed F. Cytokine profile in the synovial fluid of patients with temporomandibular joint disorders: A systematic review. Cytokine. 2016 Jan;77:98-106. doi: 10.1016/j.cyto.2015.11.005. Epub 2015 Nov 7.

  PMID: 26556103 BACKGROUND

• Kaneyama K, Segami N, Sun W, Sato J, Fujimura K. Analysis of tumor necrosis factor-alpha, interleukin-6, interleukin-1beta, soluble tumor necrosis factor receptors I and II, interleukin-6 soluble receptor, interleukin-1 soluble receptor type II, interleukin-1 receptor antagonist, and protein in the synovial fluid of patients with temporomandibular joint disorders. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005 Mar;99(3):276-84. doi: 10.1016/j.tripleo.2004.06.074.

  PMID: 15716832 BACKGROUND

• Kaneyama K, Segami N, Sato J, Murakami K, Iizuka T. Outcomes of 152 temporomandibular joints following arthroscopic anterolateral capsular release by holmium: YAG laser or electrocautery. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2004 May;97(5):546-51; discussion 552. doi: 10.1016/S1079210403007261.

  PMID: 15153864 BACKGROUND

• Jasim H, Ernberg M, Carlsson A, Gerdle B, Ghafouri B. Protein Signature in Saliva of Temporomandibular Disorders Myalgia. Int J Mol Sci. 2020 Apr 7;21(7):2569. doi: 10.3390/ijms21072569.

  PMID: 32272779 BACKGROUND

• Holmlund AB, Gynther G, Axelsson S. Diskectomy in treatment of internal derangement of the temporomandibular joint. Follow-up at 1, 3, and 5 years. Oral Surg Oral Med Oral Pathol. 1993 Sep;76(3):266-71. doi: 10.1016/0030-4220(93)90250-8.

  PMID: 8378038 BACKGROUND

• Holmlund AB, Axelsson S, Gynther GW. A comparison of discectomy and arthroscopic lysis and lavage for the treatment of chronic closed lock of the temporomandibular joint: a randomized outcome study. J Oral Maxillofac Surg. 2001 Sep;59(9):972-7; discussion 977-8. doi: 10.1053/joms.2001.25818.

  PMID: 11526556 BACKGROUND

• Holmlund A, Gynther G, Axelsson S. Efficacy of arthroscopic lysis and lavage in patients with chronic locking of the temporomandibular joint. Int J Oral Maxillofac Surg. 1994 Oct;23(5):262-5. doi: 10.1016/s0901-5027(05)80104-3.

  PMID: 7890964 BACKGROUND

• Herr MM, Fries KM, Upton LG, Edsberg LE. Potential biomarkers of temporomandibular joint disorders. J Oral Maxillofac Surg. 2011 Jan;69(1):41-7. doi: 10.1016/j.joms.2010.05.013.

  PMID: 21163381 BACKGROUND

• Gynther GW, Holmlund AB, Reinholt FP, Lindblad S. Temporomandibular joint involvement in generalized osteoarthritis and rheumatoid arthritis: a clinical, arthroscopic, histologic, and immunohistochemical study. Int J Oral Maxillofac Surg. 1997 Feb;26(1):10-6. doi: 10.1016/s0901-5027(97)80838-7.

  PMID: 9081245 BACKGROUND

• Gynther GW, Holmlund AB, Reinholt FP. Synovitis in internal derangement of the temporomandibular joint: correlation between arthroscopic and histologic findings. J Oral Maxillofac Surg. 1994 Sep;52(9):913-7; discussion 918. doi: 10.1016/s0278-2391(10)80066-7.

  PMID: 8064453 BACKGROUND

• Gonzalez-Garcia R, Rodriguez-Campo FJ, Escorial-Hernandez V, Munoz-Guerra MF, Sastre-Perez J, Naval-Gias L, Gil-Diez Usandizaga JL. Complications of temporomandibular joint arthroscopy: a retrospective analytic study of 670 arthroscopic procedures. J Oral Maxillofac Surg. 2006 Nov;64(11):1587-91. doi: 10.1016/j.joms.2005.12.058.

  PMID: 17052583 BACKGROUND

• Gonzalez-Garcia R, Rodriguez-Campo FJ. Arthroscopic lysis and lavage versus operative arthroscopy in the outcome of temporomandibular joint internal derangement: a comparative study based on Wilkes stages. J Oral Maxillofac Surg. 2011 Oct;69(10):2513-24. doi: 10.1016/j.joms.2011.05.027.

  PMID: 21939814 BACKGROUND

• Gonzalez LV, Lopez JP, Diaz-Baez D, Orjuela MP, Chavez M. Clinical outcomes of operative arthroscopy and temporomandibular medical infiltration with platelet-rich fibrin in upper and lower articular space. J Craniomaxillofac Surg. 2021 Dec;49(12):1162-1168. doi: 10.1016/j.jcms.2021.07.001. Epub 2021 Aug 3.

  PMID: 34384651 BACKGROUND

• Fu K, Ma X, Zhang Z, Chen W. Tumor necrosis factor in synovial fluid of patients with temporomandibular disorders. J Oral Maxillofac Surg. 1995 Apr;53(4):424-6. doi: 10.1016/0278-2391(95)90717-3.

  PMID: 7699497 BACKGROUND

• Fernandez Sanroman J, Costas Lopez A, Fernandez Ferro M, de Sanchez AL, Stavaru B, Arenaz Bua J. Complications of temporomandibular joint arthroscopy using two-portal coblation technologies: A prospective study of 475 procedures. J Craniomaxillofac Surg. 2016 Sep;44(9):1221-5. doi: 10.1016/j.jcms.2016.06.027. Epub 2016 Jul 2.

  PMID: 27443801 BACKGROUND

• Eriksson L, Westesson PL. Discectomy as an effective treatment for painful temporomandibular joint internal derangement: a 5-year clinical and radiographic follow-up. J Oral Maxillofac Surg. 2001 Jul;59(7):750-8; discussion 758-9. doi: 10.1053/joms.2001.24288.

  PMID: 11429734 BACKGROUND

• Doetzer AD, Herai RH, Buzalaf MAR, Trevilatto PC. Proteomic Expression Profile in Human Temporomandibular Joint Dysfunction. Diagnostics (Basel). 2021 Mar 28;11(4):601. doi: 10.3390/diagnostics11040601.

  PMID: 33800589 BACKGROUND

• Chowdhury SKR, Saxena V, Rajkumar K, Shadamarshan RA. Complications of Diagnostic TMJ Arthroscopy: An Institutional Study. J Maxillofac Oral Surg. 2019 Dec;18(4):531-535. doi: 10.1007/s12663-019-01202-3. Epub 2019 Feb 26.

  PMID: 31624430 BACKGROUND

• Chossegros C, Cheynet F, Gola R, Pauzie F, Arnaud R, Blanc JL. Clinical results of therapeutic temporomandibular joint arthroscopy: a prospective study of 34 arthroscopies with prediscal section and retrodiscal coagulation. Br J Oral Maxillofac Surg. 1996 Dec;34(6):504-7. doi: 10.1016/s0266-4356(96)90245-4.

  PMID: 8971443 BACKGROUND

• Bjornland T, Larheim TA. Discectomy of the temporomandibular joint: 3-year follow-up as a predictor of the 10-year outcome. J Oral Maxillofac Surg. 2003 Jan;61(1):55-60. doi: 10.1053/joms.2003.50010.

  PMID: 12524609 BACKGROUND

• Al-Baghdadi M, Durham J, Steele J. Timing interventions in relation to temporomandibular joint closed lock duration: a systematic review of 'locking duration'. J Oral Rehabil. 2014 Jan;41(1):24-58. doi: 10.1111/joor.12126. Epub 2014 Jan 7.

  PMID: 24393132 BACKGROUND

• Abboud W, Yahalom R, Givol N. Treatment of Intermittent Locking of the Jaw in Wilkes Stage II Derangement by Arthroscopic Lysis and Lavage. J Oral Maxillofac Surg. 2015 Aug;73(8):1466-72. doi: 10.1016/j.joms.2015.02.027. Epub 2015 Mar 18.

  PMID: 25970513 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

Study Officials

• Mattias Ulmner, DDS, PhD

  Karolinska Institutet, Department of Dental Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mattias Ulmner, DDS, PhD

CONTACT

+46 707648141; mattias.ulmner@ki.se

Study Design

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

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 17, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2031
• Last Updated: June 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Study protocol and SAP is available through ClinicalTrials.

Locations

SE (1)