NCT07297459

Brief Summary

The goal of this clinical trial is to compare and evalute the surgical intervention discectomy to arthroscopic anterior release due to the diagnosis temporomandibular joint disc displacement with reduction. The main questions it aims to answer are:

  • which of the two surgical methods that best improves maximum interincisal opening, temporomandibular joint pain, and temporomandibular joint function.
  • could any pre- or peri-operative variable/-s be identified as a predictor for outcome.
  • are there any differences in how fast the patient recover after anterior release and discectomy, respectively.
  • are there differences regarding postoperative hospitalisation, operating time, negative side effects? Researchers will compare the six-month surgical outcome regarding the above stated interventions. Study participants have already had their intervention, i.e. the study is retrospective.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
20mo left

Started Sep 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress28%
Sep 2025Dec 2027

Study Start

First participant enrolled

September 16, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 22, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

2.3 years

First QC Date

December 9, 2025

Last Update Submit

December 22, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Maximum interincisal opening

    The maximum opening of the mouth measured with a millimetre ruler between the incisal edge of teeth 11 and 41. The change in opening before surgery compared with postoperative will be analysed.

    6 months

Secondary Outcomes (1)

  • TMJ pain

    6 months

Study Arms (2)

Discektomy

Patients that have undergone discectomy of the TMJ due to disc displacement with reduction.

Anterior release

Patients that have undergone anterior release of the TMJ due to disc displacement with reduction.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Discectomy cohort: all patients with DDwR and surgically treated at the Department of Oral- and Maxillofacial Surgery, Karolinska University Hospital, Stockholm, during the years 2014-2017. Anterior release cohort: all patients with DDwR and surgically treated at the Department of Oral- and Maxillofacial Surgery, Karolinska University Hospital, Stockholm, during the years 2019-2025.

You may qualify if:

  • Uni- or bilateral DDwR verified with clinical and/or 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, 17176, Sweden

Location

Related Publications (24)

  • 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: 9081245BACKGROUND
  • 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: 8064453BACKGROUND
  • 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: 2069635BACKGROUND
  • 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: 27443801BACKGROUND
  • 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: 11526556BACKGROUND
  • 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: 1506966BACKGROUND
  • 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: 31624430BACKGROUND
  • 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: 14690653BACKGROUND
  • 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: 28800843BACKGROUND
  • 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: 8378038BACKGROUND
  • 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: 11429734BACKGROUND
  • Abboud WA, Givol N, Yahalom R. Arthroscopic lysis and lavage for internal derangement of the temporomandibular joint. Ann Maxillofac Surg. 2015 Jul-Dec;5(2):158-62. doi: 10.4103/2231-0746.175754.

    PMID: 26981463BACKGROUND
  • 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: 25970513BACKGROUND
  • 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: 34384651BACKGROUND
  • 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: 18226569BACKGROUND
  • Choi DD, Vandenberg K, Smith D, Davis C, McCain JP. Is Temporomandibular Joint Arthroscopy Effective in Managing Pediatric Temporomandibular Joint Disorders in the Short- and Long-Term? J Oral Maxillofac Surg. 2020 Jan;78(1):44-51. doi: 10.1016/j.joms.2019.07.011. Epub 2019 Jul 31.

    PMID: 31454503BACKGROUND
  • 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: 21939814BACKGROUND
  • Ulmner M, Bjornland T, Rosen A, Berge TI, Olsen-Bergem H, Lund B. Evidence for minimally invasive treatment-A systematic review on surgical management of disc displacement. J Oral Rehabil. 2024 Jun;51(6):1061-1080. doi: 10.1111/joor.13661. Epub 2024 Feb 23.

    PMID: 38400536BACKGROUND
  • Badri O, Davis CM, Warburton G. Arthroscopic management and recent advancements in the treatment of temporomandibular joint disorders. Br J Oral Maxillofac Surg. 2024 Nov;62(9):820-825. doi: 10.1016/j.bjoms.2024.07.007. Epub 2024 Jul 31.

    PMID: 39181842BACKGROUND
  • 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: 26644030BACKGROUND
  • 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: 24393132BACKGROUND
  • 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: 35534826BACKGROUND
  • 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: 2923691BACKGROUND
  • 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: 23249569BACKGROUND

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 9, 2025

First Posted

December 22, 2025

Study Start

September 16, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

December 30, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

All IPD aggragated on a cohort level will be published in a peer-review journal.

Locations