Alloplastic Total Temporomandibular Joint (TMJ) Replacement Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Temporomandibular Joint Disorders. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil, Colombia, Denmark, Germany, India +10
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
International, Multicenter, Prospective Registry to Collect Data of Patients Treated With Alloplastic Total Temporomandibular Joint (TMJ) Replacements
Overview
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.
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
Primary outcome measures
- 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)]
Secondary outcome measures (12)
- Demographics [Time frame: pre-operative]
- Comorbidities [Time frame: pre-operative]
- Refusal of alloplastic total TMJ replacement surgery [Time frame: pre-operative]
- Clinical and functional outcomes - Mandibular movements [Time frame: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)]
- Clinical and functional outcomes - Occlusal status [Time frame: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)]
- Clinical and functional outcomes - Dentition [Time frame: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)]
- Clinical and functional outcomes - Helkimo Clinical dysfunction index [Time frame: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)]
- Patient Reported Outcomes - Pain numeric rating scale (NRS) [Time frame: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)]
- Patient Reported Outcomes - Jaw function NRS [Time frame: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)]
- Patient Reported Outcomes - Diet limitation NRS [Time frame: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months)]
- Patient Reported Outcomes - EuroQoL five dimension (EQ-5D-5L) [Time frame: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months]
- Patient Reported Outcomes - Oral Health Impact Profile (OHIP) - 14 [Time frame: from the pre-operative assessment until 60 months after surgery (10 days / 3 months / 6 months / 12 months / 24 months / 60 months]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 4 centers
- Hannover Medical School — Hanover
- University Hospital Leipzig — Leipzig
- Klinikum der Johannes Gutenberg Universität Mainz — Mainz
- Klinikum der LMU München — Munich
Sweden · 4 centers
- Falu Hospital — Falun
- Skåne University Hospital — Lund
- Karolinska University Hospital — Stockholm
- Uppsala University Hospital — Uppsala
India · 2 centers
- Sri Shankara Cancer Hospital and Research Center — Bangalore
- All India Institute of Medical Sciences (AIIMS) — New Delhi
New Zealand · 2 centers
- Waikato DHB — Christchurch
- Hutt Hospital — Lower Hutt
Brazil · 1 center
- Hospital BP - A Beneficência Portuguesa de São Paulo — São Paulo
Colombia · 1 center
- Estetica Maxilofacial — Bogotá
Denmark · 1 center
- Rigshospitalet — Copenhagen
Netherlands · 1 center
- Erasmus Medisch Centrum — Rotterdam
Pakistan · 1 center
- Mayo Hospital — Lahore
Poland · 1 center
- Wojewódzki Specjalistyczny Szpital Dziecięcy — Olsztyn
Russia · 1 center
- National Medical and Surgical Center named after N.I. Pirogov" of the Ministry of Healthca — Moscow
Serbia · 1 center
- Clinic for Maxillofacial Surgery, University of Belgrade — Belgrade
South Africa · 1 center
- King Edward VIII Hospital — Durban
Spain · 1 center
- 12 de Octubre University Hospital — Madrid
Switzerland · 1 center
- Universitätsspital Basel — Basel
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: PMID 41802784
Identifiers
NCT: NCT03991728 · TMJ Replacement