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Alloplastic total temporomandibular joint (TMJ) replacement registry : a protocol for a prospective global multicentre observational cohort study

Thor, Andreas ; Bengtsson, Martin LU orcid ; Dowgierd, Krzysztof ; Epifanov, Sergey ; Fichter, Andreas M ; Jelovac, Drago ; Korn, Philippe N ; Nilsson, Johanna L ; Pastore, Gabriel and Rughubar, Vivesh , et al. (2026) In BMJ Open 16(3). p.1-10
Abstract

INTRODUCTION: Total alloplastic replacement of the temporomandibular joint (TMJ) is a viable treatment option for severe TMJ disorders (TMDs) unresponsive to conservative approaches, as well as for reconstruction of congenital or acquired TMJ defects. However, clinical data on indications, outcomes, complications and long-term effects remain limited, and no global registry currently exists. This study aims to address this gap by establishing an international registry to collect data from patients undergoing total alloplastic TMJ replacement systematically. The registry will document clinical indications and disease progression, explore relationships between treatments, outcomes and quality of life, identify predictors of favourable... (More)

INTRODUCTION: Total alloplastic replacement of the temporomandibular joint (TMJ) is a viable treatment option for severe TMJ disorders (TMDs) unresponsive to conservative approaches, as well as for reconstruction of congenital or acquired TMJ defects. However, clinical data on indications, outcomes, complications and long-term effects remain limited, and no global registry currently exists. This study aims to address this gap by establishing an international registry to collect data from patients undergoing total alloplastic TMJ replacement systematically. The registry will document clinical indications and disease progression, explore relationships between treatments, outcomes and quality of life, identify predictors of favourable outcomes and inform future research.

METHODS AND ANALYSIS: This international, prospective, multicentre, observational registry will enrol approximately 200 patients with TMD requiring total alloplastic TMJ replacement, with follow-up lasting up to 5 years postoperatively. The data collected will include underlying disease, treatment details, functional outcomes, patient-reported outcomes and procedure-related adverse events. The registry will also monitor patients who decline surgery and record their reasons. All treatments will adhere to the standard of care at each participating centre.

ETHICS AND DISSEMINATION: Ethics approval was obtained from the responsible ethics committee (EC) at each participating site prior to TMJ surgery. All patients will be enrolled following an informed consent process approved by the relevant EC. Study results will be disseminated through peer-reviewed publications.Approving ECs include: Krishnadevaraya College of Dental Sciences and Hospital EC, KCDS/Ethical Comm/54/2022-23; Ethikkommission Nordwest- und Zentralschweiz, 2019-02387; University of Belgrade School of Dental Medicine EC, 36/19; National Videnskabsetisk Komité, 2401881; University of KwaZulu-Natal Biomedical Research EC, BREC/00001592/2020; Etikprövningsmyndigheten, 2019-04477; Ethikkommission Medizinische Hochschule Hannover, 8660_BO_K_2019; Ethik-Kommission an der Medizinischen Fakultät der Universität Leipzig, 080/21-lk; Comité de Ética de la Investigación con Medicamentos Hospital Universitario 12 de Octubre, 19/392; Landesärztekammer Rheinland-Pfalz EC, 2025-18012-andere Forschung/nachberatend; Local Ethical Committee at National Medical and Surgical Centre named after NI Pirogoov, LEC meeting 5; Ethikkommission bei der LMU München, 19-589; Komisja Bioetyczna przy Warmińsko-Mazurskiej Izbie Lekarskiej w Olsztynie, 12/2021; De Medisch Ethische Toetsings Commissie Erasmus MC, MEC-2019-0696 and Comissão Nacional de Ética em Pesquisa, 3.825.711.

TRIAL REGISTRATION NUMBER: NCT03991728.

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Contribution to journal
publication status
published
keywords
Humans, Registries, Temporomandibular Joint Disorders/surgery, Prospective Studies, Arthroplasty, Replacement/methods, Temporomandibular Joint/surgery, Multicenter Studies as Topic, Observational Studies as Topic, Quality of Life, Female, Male
in
BMJ Open
volume
16
issue
3
article number
e113558
pages
1 - 10
publisher
BMJ Publishing Group
external identifiers
  • scopus:105032864383
  • pmid:41802784
ISSN
2044-6055
DOI
10.1136/bmjopen-2025-113558
language
English
LU publication?
no
additional info
© Author(s) (or their employer(s)) 2026. Re-use permitted under CC BY. Published by BMJ Group.
id
4ae3c1f4-8b99-4c7a-8dd1-ceee5831c682
date added to LUP
2026-03-18 17:08:06
date last changed
2026-09-08 16:21:11
@article{4ae3c1f4-8b99-4c7a-8dd1-ceee5831c682,
  abstract     = {{<p>INTRODUCTION: Total alloplastic replacement of the temporomandibular joint (TMJ) is a viable treatment option for severe TMJ disorders (TMDs) unresponsive to conservative approaches, as well as for reconstruction of congenital or acquired TMJ defects. However, clinical data on indications, outcomes, complications and long-term effects remain limited, and no global registry currently exists. This study aims to address this gap by establishing an international registry to collect data from patients undergoing total alloplastic TMJ replacement systematically. The registry will document clinical indications and disease progression, explore relationships between treatments, outcomes and quality of life, identify predictors of favourable outcomes and inform future research.</p><p>METHODS AND ANALYSIS: This international, prospective, multicentre, observational registry will enrol approximately 200 patients with TMD requiring total alloplastic TMJ replacement, with follow-up lasting up to 5 years postoperatively. The data collected will include underlying disease, treatment details, functional outcomes, patient-reported outcomes and procedure-related adverse events. The registry will also monitor patients who decline surgery and record their reasons. All treatments will adhere to the standard of care at each participating centre.</p><p>ETHICS AND DISSEMINATION: Ethics approval was obtained from the responsible ethics committee (EC) at each participating site prior to TMJ surgery. All patients will be enrolled following an informed consent process approved by the relevant EC. Study results will be disseminated through peer-reviewed publications.Approving ECs include: Krishnadevaraya College of Dental Sciences and Hospital EC, KCDS/Ethical Comm/54/2022-23; Ethikkommission Nordwest- und Zentralschweiz, 2019-02387; University of Belgrade School of Dental Medicine EC, 36/19; National Videnskabsetisk Komité, 2401881; University of KwaZulu-Natal Biomedical Research EC, BREC/00001592/2020; Etikprövningsmyndigheten, 2019-04477; Ethikkommission Medizinische Hochschule Hannover, 8660_BO_K_2019; Ethik-Kommission an der Medizinischen Fakultät der Universität Leipzig, 080/21-lk; Comité de Ética de la Investigación con Medicamentos Hospital Universitario 12 de Octubre, 19/392; Landesärztekammer Rheinland-Pfalz EC, 2025-18012-andere Forschung/nachberatend; Local Ethical Committee at National Medical and Surgical Centre named after NI Pirogoov, LEC meeting 5; Ethikkommission bei der LMU München, 19-589; Komisja Bioetyczna przy Warmińsko-Mazurskiej Izbie Lekarskiej w Olsztynie, 12/2021; De Medisch Ethische Toetsings Commissie Erasmus MC, MEC-2019-0696 and Comissão Nacional de Ética em Pesquisa, 3.825.711.</p><p>TRIAL REGISTRATION NUMBER: NCT03991728.</p>}},
  author       = {{Thor, Andreas and Bengtsson, Martin and Dowgierd, Krzysztof and Epifanov, Sergey and Fichter, Andreas M and Jelovac, Drago and Korn, Philippe N and Nilsson, Johanna L and Pastore, Gabriel and Rughubar, Vivesh and Smolka, Wenko and Talvilahti, Jani and Thiem, Daniel and Thieringer, Florian and Ulmner, Mattias and Wolvius, Eppo B and Zubillaga Rodríguez, Ignacio and Kumar, Vinay V}},
  issn         = {{2044-6055}},
  keywords     = {{Humans; Registries; Temporomandibular Joint Disorders/surgery; Prospective Studies; Arthroplasty, Replacement/methods; Temporomandibular Joint/surgery; Multicenter Studies as Topic; Observational Studies as Topic; Quality of Life; Female; Male}},
  language     = {{eng}},
  month        = {{03}},
  number       = {{3}},
  pages        = {{1--10}},
  publisher    = {{BMJ Publishing Group}},
  series       = {{BMJ Open}},
  title        = {{Alloplastic total temporomandibular joint (TMJ) replacement registry : a protocol for a prospective global multicentre observational cohort study}},
  url          = {{http://dx.doi.org/10.1136/bmjopen-2025-113558}},
  doi          = {{10.1136/bmjopen-2025-113558}},
  volume       = {{16}},
  year         = {{2026}},
}