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Temporomandibular Disorders (TMD)NCT07373184

Virtual Planning of Total Temporomandibular Joint Replacement

An observational study of Temporomandibular Disorders (TMD) and Temporomandibular Joint Ankylosis, run by Lund University Hospital at 1 site in Sweden.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Any age
How many people
30 participants
Where
1 siteSweden
Study dates
1 Feb 2026to 31 Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Martin Bengtsson, DDS, PhD contact

+4646171100

martin.n.bengtsson@skane.se

Sweden1 site, 1 recruiting
  • Department of Oral and Maxillofacial Surgery

    Lund, 22185

    Martin Bengtsson, DDS, OMS, PhD, 004646171100, martin.n.bengtsson@skane.se

    Martin Bengtsson, DDS, OMS, PhD

    Recruiting

Other trials in Sweden

About this study

Official title: 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.

Read more

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.

Read the 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.

Keywords
temporomandibular joint, temporomandibular disorder, ankylosis, joint prosthesis, total joint replacement
Medical subject headings
Temporomandibular Joint Disorders, Temporomandibular ankylosis, Ankylosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 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)
  1. Recorded surgical movements to correct a severe malocclusion.

    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

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2026
  2. Study start1 Feb 2026
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07373184
Sponsor's protocol ID
2025-01826-01
Other IDs
2025
Status last verified
Feb 2026
First submitted
11 Dec 2025
Last updated
5 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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 Feb;76(2):294-303. doi: 10.1016/j.joms.2017.08.022. Epub 2017 Aug 24.

    PubMed 28919368
  • 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 Dec;53(12):1065-1067. doi: 10.1016/j.ijom.2024.08.035. Epub 2024 Sep 3.

    PubMed 39232864
  • Peres Lima FGG, Rios LGC, Bianchi J, Goncalves JR, Paranhos LR, Vieira WA, Zanetta-Barbosa D. Complications of total temporomandibular joint replacement: a systematic review and meta-analysis. Int J Oral Maxillofac Surg. 2023 May;52(5):584-594. doi: 10.1016/j.ijom.2022.10.009. Epub 2022 Dec 7.

    PubMed 36494246
  • 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 Aug;51(8):1059-1068. doi: 10.1016/j.ijom.2021.12.012. Epub 2022 Jan 7.

    PubMed 35012826
  • 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 Jun;32(3):268-74. doi: 10.1054/ijom.2002.0350.

    PubMed 12767873
  • 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 May;51(5):665-668. doi: 10.1016/j.ijom.2021.07.021. Epub 2021 Sep 7.

    PubMed 34503888
  • 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 Jul;54(6):604-9. doi: 10.1016/j.bjoms.2016.03.005. Epub 2016 Mar 22.

    PubMed 27015729
  • 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 Jan;46(1):86-92. doi: 10.1016/j.ijom.2016.08.022. Epub 2016 Sep 17.

    PubMed 27644588
  • 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 Jan 17;14(2):580. doi: 10.3390/jcm14020580.

    PubMed 39860584
  • Lima FGGP, Rios LGC, Paranhos LR, Vieira WA, Zanetta-Barbosa D. Survival of temporomandibular total joint replacement: A systematic review and meta-analysis. J Oral Rehabil. 2024 Apr;51(4):775-784. doi: 10.1111/joor.13635. Epub 2023 Dec 10.

    PubMed 38071499
  • 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 Aug;42(8):1007-13. doi: 10.1016/j.ijom.2013.04.018. Epub 2013 Jun 12.

    PubMed 23769150
  • 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 Apr;70(4):787-94; discussion 795-6. doi: 10.1016/j.joms.2011.09.031.

    PubMed 22449430

Questions about this trial

What is this clinical trial studying?

An observational study of Temporomandibular Disorders (TMD) and Temporomandibular Joint Ankylosis, run by Lund University Hospital at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Martin Bengtsson, DDS, PhD (+4646171100, martin.n.bengtsson@skane.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07373184, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.

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