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Temporomandibular Joint DisordersNCT03991728

Alloplastic Total Temporomandibular Joint (TMJ) Replacement Registry

An observational study of Temporomandibular Joint Disorders, run by AO Innovation Translation Center at 23 sites in 15 countries.

Recruiting

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

Sites and contacts
Official record
Search all trials

Trial summary

Prospective data will be collected in approximately 200 patients treated with an TMJ replacement. Patients will be followed up according to the standard (routine) for up to 5 years after the treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Temporomandibular Joint Disorders
How many people
200 participants
Where
23 sitesin 15 countries
Study dates
15 Oct 2019to Dec 2033
How long will I take part?
5 Years
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients requiring alloplastic total TMJ replacement

Who may be able to join

  • Age 18 years and or older
  • Patients requiring alloplastic total TMJ replacement
  • Informed consent obtained, i.e.:
  • Ability to understand the content of the patient information/informed consent form (ICF)
  • Willingness and ability to participate in the registry according to the Registry Plan (RP)
  • Signed and dated ethics committee (EC) / Institutional review board (IRB) approved written informed consent

Who cannot join

  • Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment
  • Pregnancy or women planning to conceive within the study period
  • Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study

Trial locations and contacts

23 sites in 15 countries. Contact the study team or a site near you to ask about taking part.

Viola Grünenfelder contact

+41 79 696 33 97

viola.gruenenfelder@aofoundation.org

Alix Frischknecht contact

alix.frischknecht@aofoundation.org

23 sites in 15 countries

Germany4 sites, 4 recruiting

  • Hannover Medical School

    Hanover, 30625

    Philippe Korn, MD, korn.philippe@mh-hannover.de

    Recruiting

  • University Hospital Leipzig

    Leipzig

    Rüdiger Zimmerer, MD, +49341-97204443, Ruediger.Zimmerer@medizin.uni-leipzig.de

    Recruiting

  • Klinikum der Johannes Gutenberg Universität Mainz

    Mainz, 55131

    Daniel Thiem

    Not yet recruiting

  • Klinikum der LMU München

    Munich, 80337

    Wenko Smolka, MD

    Recruiting

Other trials in Germany

Sweden4 sites, 4 recruiting

  • Falu Hospital

    Falun, 79182

    Jani Talvilahti, MD

    Recruiting

  • Skåne University Hospital

    Lund

    Martin Bengtsson, MD

    Recruiting

  • Karolinska University Hospital

    Stockholm

    Mattias Ulmner, MD

    Recruiting

  • Uppsala University Hospital

    Uppsala, SE-75185

    Andreas Thor, MD, +46 (0)18 611 6450, andreas.thor@akademiska.se

    Recruiting

Other trials in Sweden

India2 sites, 1 recruiting

  • Sri Shankara Cancer Hospital and Research Center

    Bangalore

    Vinay V Kumar, MD

    Recruiting

  • All India Institute of Medical Sciences (AIIMS)

    New Delhi, 110029

    Terminated

Other trials in India

New Zealand2 sites

  • Waikato DHB

    Christchurch

    Terminated

  • Hutt Hospital

    Lower Hutt

    Suspended

Other trials in New Zealand

Brazil1 site, 1 recruiting

  • Hospital BP - A Beneficência Portuguesa de São Paulo

    São Paulo

    Gabriel Pastore, MD

    Recruiting

Other trials in Brazil

Colombia1 site

  • Estetica Maxilofacial

    Bogotá

    Suspended

Other trials in Colombia

Denmark1 site, 1 recruiting

  • Rigshospitalet

    Copenhagen, 2100

    Johanna Nilsson, MD, johanna.lisa.nilsson@gmail.com

    Recruiting

Other trials in Denmark

Netherlands1 site, 1 recruiting

  • Erasmus Medisch Centrum

    Rotterdam, 3075

    Eppo Wolvius, MD

    Recruiting

Other trials in Netherlands

Pakistan1 site

  • Mayo Hospital

    Lahore

    Terminated

Other trials in Pakistan

Poland1 site, 1 recruiting

  • Wojewódzki Specjalistyczny Szpital Dziecięcy

    Olsztyn

    Krzysztof Dowgierd, MD, +48 89 539 32 61, krzysztofdowgierd@gmail.com

    Recruiting

Other trials in Poland

Russia1 site, 1 recruiting

  • National Medical and Surgical Center named after N.I. Pirogov" of the Ministry of Healthcare of the Russian Federation

    Moscow

    Sergey Epifanov, MD

    Recruiting

Other trials in Russia

Serbia1 site, 1 recruiting

  • Clinic for Maxillofacial Surgery, University of Belgrade

    Belgrade

    Drago Jelovac, MD, +381112685268, drago.jelovac@stomf.bg.ac.rs

    Recruiting

Other trials in Serbia

South Africa1 site, 1 recruiting

  • King Edward VIII Hospital

    Durban, 4030

    Vivesh Rughubar, MD

    Recruiting

Other trials in South Africa

Spain1 site, 1 recruiting

  • 12 de Octubre University Hospital

    Madrid, 28041

    Ignacio Zubillaga, MD

    Recruiting

Other trials in Spain

Switzerland1 site, 1 recruiting

  • Universitätsspital Basel

    Basel

    Florian Thieringer, MD

    Recruiting

Other trials in Switzerland

About this study

Official title: International, Multicenter, Prospective Registry to Collect Data of Patients Treated With Alloplastic Total Temporomandibular Joint (TMJ) Replacements

Prospective data will be collected in approximately 200 patients treated with an TMJ replacement. Patients will be followed up according to the standard (routine) for up to 5 years after the treatment. Data collection will include underlying disease, treatment details, functional and patient reported outcomes (PRO)s and anticipated or procedure-related adverse events (i.e. complications).

This registry is designed to be able to assess the number of patients who refuse alloplastic total TMJ replacement. Therefore, the participating sites are asked to register all cases of refused TMJ replacements too.

Read the detailed description

More in detail this registry has the following objectives:

  • To describe clinical indications for TMJ replacement, and treatment patterns (including differences among regions if feasible)
  • To describe the clinical evolution and outcomes of patients treated with a TMJ replacement
  • To explore the relationship(s) between treatment, outcome(s) and quality of life (QoL).
  • To identify predictive factors for favorable outcomes (pain reduction, range of motion (ROM), occlusal status, QoL) in patients treated with TMJ replacement.
  • To describe the reasons of patients who refused TMJ replacements
Keywords
Temporomandibular joint, TMJ replacement, Trauma, Ankylosis, Degenerative joint disease, Registry
Medical subject headings
Temporomandibular Joint Disorders, Wounds and Injuries, Ankylosis, Joint Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03991728
Study groupRoleWhat they receive
Alloplastic total TMJ replacementAll treatments will remain the standard (routine) care procedures based on individual clinician's judgment and the patient characteristics. The registry does not dictate any specific treatment.

What is being measured

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

  1. The registry has no primary but several objectives.

    due to the study design, no primary objective has been defined and therefore no primary outcome measure either

    Measured: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)

Secondary outcomes (20)

  1. Demographics

    Year of birth Gender Smoking

    Measured: pre-operative

  2. Comorbidities

    Concomitant diseases will be assessed using the Charlson Comorbidity Index (CCI). This score assesses the comorbidity level by considering both the number and severity of pre-defined comorbid conditions. It provides a weighted score of a patient's comorbidities which can be used to predict mortality rates

    Measured: pre-operative

  3. Refusal of alloplastic total TMJ replacement surgery

    For patients who require alloplastic total TMJ replacement but refuse surgery, the reason(s) for refusal will be collected.

    Measured: pre-operative

  4. Clinical and functional outcomes - Mandibular movements

    Interincisial opening/maximal opening Lateral movements Protrusive movement

    Measured: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)

  5. Clinical and functional outcomes - Occlusal status

    Occlusion will be assessed according to Angle's classification:

    Measured: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)

  6. Clinical and functional outcomes - Dentition

    Dental status will be recorded as:

    • Edentulous
    • Complete dentition
    • Partial dentition In case of partial dentition, missing teeth will be recorded individually using the Fédération Dentaire Internationale (FDI) tooth numbering formula .

    Measured: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)

  7. Clinical and functional outcomes - Helkimo Clinical dysfunction index

    The dysfunction of the mandible will be evaluated by means of the Helkimo index. The Helkimo index is based on the assessment of five different symptoms.

    Measured: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)

  8. Patient Reported Outcomes - Pain numeric rating scale (NRS)

    The Pain NRS is an 11-point scale where the end points are the extremes of no pain (0 points), to worst imaginable pain (10 points). It measures subjective intensity of pain and the patient rates his/her overall or average daily pain.

    Will be assessed independently for each site.

    Measured: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)

  9. Patient Reported Outcomes - Jaw function NRS

    The jaw function NRS is an 11-point scale where the end points are the extremes of normal jaw movement (0 points), to no jaw movement (10 points). It measures subjective jaw function.

    Measured: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)

  10. Patient Reported Outcomes - Diet limitation NRS

    The diet limitation NRS is an 11-point scale where the end points are the extremes of no restrictions (0 points), to liquids only (10 points). It measures subjective diet limitations.

    Measured: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)

  11. Patient Reported Outcomes - EuroQoL five dimension (EQ-5D-5L)

    The EQ-5D-5L descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results into a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

    Measured: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months

  12. Patient Reported Outcomes - Oral Health Impact Profile (OHIP) - 14

    The OHIP is concerned with impairment and three functional status dimensions (social, psychological and physical) which represent four of the seven quality of life dimensions proposed by Patrick and Bergner. Hence, it excludes perceptions of satisfaction with oral health, changes in oral health, prognosis or self-reported diagnoses. Furthermore, the OHIP aims to capture impacts that are related to oral conditions in general, rather than impacts that may be attributed to specific oral disorders or syndromes. All impacts in the OHIP are conceptualized as adverse outcomes, and therefore the instrument does not measure any positive aspects of oral health. The OHIP consists of 14 items evaluated using a 5-point Likert from "Never" to "Very often " in which higher scores indicated worse outcomes. It has validated translations to Swedish, Spanish, German, Hindi and further more.

    Measured: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months

  13. Anticipated treatment or condition-related adverse events (i.e. complications)

    In this registry, only anticipated condition, treatment-, or implant-related adverse events (i.e. complications) will be documented in the electronic case report form (eCRF) from the time of consent onwards.

    In the context of the registry, these events are considered as events of scientific interest, i.e. events that can clearly be connected to the treatment(s) or the medical condition under investigation. These events do not require immediate reporting unless they occur at a higher frequency and/or severity to that cited in the literature

    Measured: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)

  14. Survival

    Follow up (FU) visits will be scheduled and performed according to the local standard of care and at each scheduled visit the patient's survival will be documented. In case a patient misses a scheduled visit, it will be assessed if the patient is still alive, which can be done via phone call.

    Measured: 10 days / 3 months / 6 months / 12 months / 24 months / 60 months

  15. Radiological parameters - Displacement of ramus component

    All images (preferably computed tomography (CT) / cone beam (CB) CT scan) taken as part of the standard (routine) will be collected and 'displacement of ramus component' evaluated by local investigator:

    Measured: pre-operative / 10 days / 12 months / 24 months

  16. Radiological parameters - Fracture of ramus component

    All images (preferably computed tomography (CT) / cone beam (CB) CT scan) taken as part of the standard (routine) will be collected and evaluated by local investigator if a 'fracture of the ramus component' occurred

    Measured: pre-operative / 10 days / 12 months / 24 months

  17. Radiological parameters - Screw loosening

    All images (preferably computed tomography (CT) / cone beam (CB) CT scan) taken as part of the standard (routine) will be collected and evaluated by local investigator if 'screw loosening' occurred

    Measured: pre-operative / 10 days / 12 months / 24 months

  18. Radiological parameters - Resorption/ osteolysis of surrounding bone

    All images (preferably computed tomography (CT) / cone beam (CB) CT scan) taken as part of the standard (routine) will be collected and 'resorption/ osteolysis of surrounding bone' evaluated by local investigator

    Measured: pre-operative / 10 days / 12 months / 24 months

  19. Radiological parameters - Status of bone grafts if used (displaced/ resorbed/ healed)

    All images (preferably computed tomography (CT) / cone beam (CB) CT scan) taken as part of the standard (routine) will be collected and 'status of bone grafts if used (displaced/ resorbed/ healed)' evaluated by local investigator

    Measured: pre-operative / 10 days / 12 months / 24 months

  20. Radiological parameters - Presence of ectopic bone

    All images (preferably computed tomography (CT) / cone beam (CB) CT scan) taken as part of the standard (routine) will be collected and 'presence of ectopic bone' evaluated by local investigator

    Measured: pre-operative / 10 days / 12 months / 24 months

Timeline

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

  1. First posted19 Jun 2019
  2. Study start15 Oct 2019
  3. Primary completionSep 2032 (estimated)
  4. Study completionDec 2033 (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
Prospective
Enrolment
200 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03991728
Sponsor's protocol ID
TMJ Replacement
Status last verified
Sep 2026
First submitted
12 Jun 2019
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Thor A, Bengtsson M, Dowgierd K, Epifanov S, Fichter AM, Jelovac D, Korn PN, Nilsson JL, Pastore G, Rughubar V, Smolka W, Talvilahti J, Thiem D, Thieringer F, Ulmner M, Wolvius EB, Zubillaga Rodriguez I, Kumar VV. Alloplastic total temporomandibular joint (TMJ) replacement registry: a protocol for a prospective global multicentre observational cohort study. BMJ Open. 2026 Mar 9;16(3):e113558. doi: 10.1136/bmjopen-2025-113558.

    PubMed 41802784

Questions about this trial

What is this clinical trial studying?

An observational study of Temporomandibular Joint Disorders, run by AO Innovation Translation Center at 23 sites in 15 countries.

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 6 inclusion and 3 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 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Germany, Sweden, India, New Zealand, Brazil and 10 more countries. 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 Viola Grünenfelder (+41 79 696 33 97, viola.gruenenfelder@aofoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The registry has no primary but several objectives. (time frame: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)). 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 NCT03991728, which also lists 1 linked publication.

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 16 Sep 2026.

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