Virtual Planning of Total Temporomandibular Joint Replacement

February 4, 2026 updated by: Lund University Hospital

Three-dimensional Virtual Planning of Total Temporomandibular Joint Replacement Using Standardized Prosthesis.

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Aim and objectives

The aim of the present study was to evaluate the possibility to perform patient specific treatment planning with the use of standardized total TMJ prosthesis on previously performed treatment with total TMJ replacement and occlusal adjustment due to a severe malocclusion. The objectives were surgical feasibility of virtual planning on standardized TMJ prosthesis measuring virtual possible maximal interface (mm2) between prosthesis and bone, possible maximal number of fixation screws and possibility to centre the mandibular part in the fossa part. The outcome measures were surgical movements to correct a severe malocclusion using standardized TMJ prosthesis.

Survey of the field

A total replacement of the temporomandibular joint (TMJ) has been successfully offered to patients with severe joint disease since more than three decades. In the early years, the surgical technique has been judged as complex and similar to other joint prosthesis the TMJ prosthesis has been burdened with some risk of complications. With emerging technologies, within computer science, biomedical design, and biocompatible materials the treatment option has been possible to use in a wider perspective. Thus, a broader patient spectrum has been possible to rehabilitate with TMJ prosthesis. Today, not only joint-related pathologic conditions are offered joint reconstruction, but also congenital deformities like Hemifacial Microsomia and Dentofacial deformities. Furthermore, the advancement of the treatment quality has enabled patients with severe joint-pathology, like Juvenile Idiopathic Arthrosis with a subsequent severe malocclusion and facial deformity, to have a total rehabilitation with both normalization of the joint function together with improved facial appearance and bite function.

However, in many of these severe cases the corrections of the facial structures simultaneously with a joint replacement provides the surgeon with a complex treatment-planning phase. Frequently, the movements need to be planned and simulated virtually to evaluate both the best positioning of segments and joint components and to manufacture surgical indexes and cutting templates. The invention of patient specific solutions (PSI) have made hardware design based on 3D radiological imaging and soft tissue predictions possible. Patient specific total TMJ prosthesis provided the surgeon with virtual planning, cutting guides, occlusal splints and well-fitted alloplastic TMJ components. However, this came with additional costs and the advantage of customized prosthesis over standardized have been debated. Attempts have been made to retrospectively compare customized with standard prosthesis, but this fare no prospective or RCT have been published. Presently, this lack of prospective comparisons leaves the evaluation with only retrospective and observational comparisons. This results in a risk of bias because of a difference in treatment indication between the compared treatment modalities. Thus, the outcome from a retrospective comparison will be coloured by a selection bias with the indication for treatment as a confounding factor.

However, while most patients with TMD might facilitate by treatment with less invasive methods than TMJ prosthesis, the other patient categories mentioned are not in a situation where they have alternative methods nor having less treatment need within time. Treating such patients at an early stage would give a rehabilitation that address all their treatment goals simultaneously, adding more years to a lifetime, with a normalized condition and a better quality of life. This with the most available and cost-effective method provided, i.e. analysis cost-utility measures using QALY. Today, a more cost-efficient treatment method might be possible using standardized total TMJ replacement prosthesis, with less cost compared with customized, in a customized planning system like VSP orthognathic surgery planning for occlusal adjustment. However, there is a possible limitation for the use of a standardized TMJ prosthesis in those patients where the anatomy of the TMJ and adjacent structures, due to pathology and/or congenital deformities, differ much from ordinary anatomy. This far, there are no clear guidelines to when a standardized TMJ prosthesis is possible to use or when any limitations of its design lead to a need of choosing a customized prosthesis.

Traditional advantages of stock devices include lower cost and immediate availability. Furthermore, stock devices work well in most cases with normal anatomy.30 It has also been stated that custom joints are implanted with a higher level of accuracy due to the feature of a virtual surgical planning (VSP). However, with a possibility to use VSP even for standard TMJ prosthesis, this advantage will no longer advocate the choice of a method that is more time-consuming and to a higher price.

The scientific hypothesis of the present study was that most TMD-caused severe malocclusions treated with a total TMJ replacement, that traditionally would be treated by a PSI TMJ prosthesis, would be possible to perform using virtual surgical planning with a standardized TMJ prosthesis.

Description of the project

Subjects

A retrospective observation study will be performed on patients treated with standard prosthesis in combination with three-dimensional virtual planning. Patients included were treated at the department of Oral and Maxillofacial Surgery, Skåne University Hospital. Lund, Sweden during 2010 to 2024.

Method

Preoperative radiographs will be used for re-evaluation of possibilities for virtual surgical planning on standardized total TMJ reconstruction.

The radiographs will during 2025 be used for a secondary treatment planning with virtual models of standardized TMJ prosthesis. Pre- and post-treatment radiographs will be analyzed, virtually treatment planned and simulated with standard prostheses in a virtual planning program. This secondary and retrospective treatment planning will be performed with the same jaw movements as were previously achieved. Three-dimensional cephalometric measurements of distances and angles between standardized landmarks will be performed in the pre- and postoperative CT images. Changes in landmark positions in the two examinations will be recorded as a measure of surgical differences.

Time plan (preliminary) Project start: 2026-01-01 Project closure: 2027-12-31

Importance

The difference between previously performed treatment and a new virtual planning in this study is that only standard prostheses will be used for temporomandibular joint reconstruction and bite correction. The method that is intended to be tested in this project combines the advantages of virtual planning with the economic advantages of standard design of temporomandibular joint prostheses.

Preliminary results

Today, no studies have been published on the combination of standardized prosthesis design and virtual planning of jaw surgery.

The method of virtual surgical planning, has been used by the applicant for this ethical review for more than 20 years and has been studied in several published clinical trial.

The method, that is intended to be tested in this project, combines the advantages of virtual planning with the economic advantages of standard design of temporomandibular joint prostheses.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Sweden
      • Lund, Sweden, 22185
        • Recruiting
        • Department of Oral and Maxillofacial Surgery
        • Contact:
        • Principal Investigator:
          • Martin Bengtsson, DDS, OMS, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurements in preoperative radiographs for re-evaluation of possibilities for virtual surgical planning on standardized total TMJ reconstruction.
Time Frame: 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

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recorded surgical movements to correct a severe malocclusion.
Time Frame: 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.

Registrations from patient journals and radiographs will include the following variables:

  • Occlusal reposition
  • Maxillary reposition
  • Mandibular movement
  • Size Fossa component
  • Size Mandibular component
  • Use of bone transplant
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University Hospital

Collaborators

Lund University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

December 11, 2025

First Submitted That Met QC Criteria

January 20, 2026

First Posted (Actual)

January 28, 2026

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-01826-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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