Virtual Planning of Total Temporomandibular Joint Replacement

NCT07373184 | Recruiting

• 1 other identifier: 2025-01826-01
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

A total TMJ replacement surgery is currently planned based on the X-ray appearance of the facial X-ray. It is now possible to use either an individually designed TMJ prosthesis or a prosthesis with a standard appearance. It is a significantly higher cost for treatment with an individually manufactured prosthesis, but it also provides the opportunity for virtual planning of the positioning of the jaws and prosthesis. By using a planning program with treatment simulation through the use of our own virtual models for standard prostheses, virtual planning of jaw and prosthesis positioning is possible even with a standardized temporomandibular joint prosthesis. In this way, the advantages of virtual planning are partly brought to the patients at a much lower price. This project aims to virtually plan treatment for patients with standardized temporomandibular joint prosthesis. Patients eligible for this study are included retrospectively (have already been treated). Their X-rays will be used for treatment planning and for comparison with the treatment outcome of previous TMJ treatment. The study will analyze the possibilities of the standardized prostheses to provide the same positions, temporomandibular joint replacements and movements of the jaw as an individual temporomandibular joint prosthesis has. This is done by measuring the planned positions of standardized temporomandibular joint prostheses compared to the treatment outcome shown by previous postoperative X-ray examinations. The study aims to clarify the possibilities of a simpler and less expensive technology, standardized temporomandibular joint prostheses, to achieve the same good treatment outcome as a more costly technology. This with the same possibilities for treatment planning and use that the existing, more expensive technology, individual temporomandibular joint prostheses, has today.

Conditions

Temporomandibular Joint Ankylosis; Temporomandibular Disorders (TMD)

Keywords

temporomandibular joint; temporomandibular disorder; ankylosis; joint prosthesis; total joint replacement

Outcome Measures

Primary Outcomes (1)

• Measurements in preoperative radiographs for re-evaluation of possibilities for virtual surgical planning on standardized total TMJ reconstruction.

  Measurements in images from virtual planned standardized TMJ prosthesis will include the following variables: * Maximal interface between bone tissue and prosthesis surface (mm2) * Size Fossa component * Size Mandibular component * Maximal number of fixation screws * Centre the mandibular part in the fossa part. * Angle between fossa and mandible part (frontal) * Angle between fossa and mandible part (sagittal)

  During 2026 retrospective virtual measurement on previous radiographs will be performed. Because patient treatments were performed during 2010 to 2025 the measurements will be performed 1 to 16 years after the recordings were performed

Secondary Outcomes (1)

• Recorded surgical movements to correct a severe malocclusion.

  During 2026 retrospective virtual measurement on previous radiographs will be performed. Because patient treatments were performed during 2010 to 2025 the measurements will be performed 1 to 16 years after the recordings were performed.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients previously treated with TMJ prosthesis at the department of Oral and Maxillofacial Surgery, Skåne University Hospital. Lund, Sweden during 2010 to 2025.

You may qualify if:

• Patients with severe pathology in the temporomandibular joint.
• Previously treated with TMJ prosthesis at the department of Oral and Maxillofacial Surgery, Skåne University Hospital, Lund, Sweden.
• Treatments performed during year 2010 to 2025.

You may not qualify if:

• \- Patients with additional surgical treatment of the TMJ after total TMJ replacement.

Sponsors & Collaborators

• Lund University Hospital: lead
• Lund University: collaborator

Study Sites (1)

Department of Oral and Maxillofacial Surgery

Lund, 22185, Sweden

RECRUITING

Related Publications (12)

• 12. Zou L, He D, Ellis E. A Comparison of Clinical Follow-Up of Different Total Temporomandibular Joint Replacement Prostheses: A Systematic Review and Meta-Analysis. J Oral Maxillofac Surg 2018;76:294-303.

  BACKGROUND

• 11. de Las Fuentes Monreal M, Escorial Hernandez V, Garcia Jimenez T, Munoz-Guerra MF. Revision of the Wolford protocol for managing infections in temporomandibular joint prostheses: an updated surgical approach. Int J Oral Maxillofac Surg 2024;53:1065-1067.

  BACKGROUND

• 10. Peres Lima FGG, Rios LGC, Bianchi J, Goncalves JR, Paranhos LR, Vieira WA, et al. Complications of total temporomandibular joint replacement: a systematic review and meta-analysis. Int J Oral Maxillofac Surg 2023;52:584-594.

  BACKGROUND

• 9. Bach E, Sigaux N, Fauvernier M, Cousin AS. Reasons for failure of total temporomandibular joint replacement: a systematic review and meta-analysis. Int J Oral Maxillofac Surg 2022;51:1059-1068.

  BACKGROUND

• 8. Wolford LM, Pitta MC, Reiche-Fischel O, Franco PF. TMJ Concepts/Techmedica custom-made TMJ total joint prosthesis: 5-year follow-up study. Int J Oral Maxillofac Surg 2003;32:268-274.

  BACKGROUND

• 7. Rajkumar A, Sidebottom AJ. Prospective study of the long-term outcomes and complications after total temporomandibular joint replacement: analysis at 10 years. Int J Oral Maxillofac Surg 2022;51:665-668.

  BACKGROUND

• 6. O'Connor RC, Saleem S, Sidebottom AJ. Prospective outcome analysis of total replacement of the temporomandibular joint with the TMJ Concepts system in patients with inflammatory arthritic diseases. Br J Oral Maxillofac Surg 2016;54:604-609.

  BACKGROUND

• 5. Johnson NR, Roberts MJ, Doi SA, Batstone MD. Total temporomandibular joint replacement prostheses: a systematic review and bias-adjusted meta-analysis. Int J Oral Maxillofac Surg 2017;46:86-92.

  BACKGROUND

• 4. Ravelo V, Vargas E, Garcia Guevara H, Sacco R, Navarro P, Olate S. TMJ Replacement in Degenerative Disease: A Systematic Review. J Clin Med 2025;14.

  BACKGROUND

• 3. Lima F, Rios LGC, Paranhos LR, Vieira WA, Zanetta-Barbosa D. Survival of temporomandibular total joint replacement: A systematic review and meta-analysis. Journal of oral rehabilitation 2024;51:775-784.

  BACKGROUND

• 2. Leandro LF, Ono HY, Loureiro CC, Marinho K, Guevara HA. A ten-year experience and follow-up of three hundred patients fitted with the Biomet/Lorenz Microfixation TMJ replacement system. Int J Oral Maxillofac Surg 2013;42:1007-1013.

  BACKGROUND

• 1. Giannakopoulos HE, Sinn DP, Quinn PD. Biomet Microfixation Temporomandibular Joint Replacement System: a 3-year follow-up study of patients treated during 1995 to 2005. J Oral Maxillofac Surg 2012;70:787-794; discussion 795-786.

  BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Temporomandibular ankylosis; Ankylosis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Martin Bengtsson, DDS, PhD

CONTACT

+4646171100; martin.n.bengtsson@skane.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: January 28, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

SE (1)