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Bioengineered Temporomandibular Joint Disk Implants: Study Protocol for a Two-Phase Exploratory Randomized Preclinical Pilot Trial in 18 Black Merino Sheep (TEMPOJIMS)

2017-03-02Journal article Open access
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datacite.subject.sdg03:Saúde de Qualidade
datacite.subject.sdg09:Indústria, Inovação e Infraestruturas
datacite.subject.sdg12:Produção e Consumo Sustentáveis
dc.contributor.authorÂngelo, David Faustino
dc.contributor.authorMonje, Florencio Gil
dc.contributor.authorGonzález-García, Raúl
dc.contributor.authorLittle, Christopher B
dc.contributor.authorMónico, Lisete
dc.contributor.authorPinho, Mário
dc.contributor.authorSantos, Fábio Abade
dc.contributor.authorCarrapiço, Belmira
dc.contributor.authorGonçalves, Sandra Cavaco
dc.contributor.authorMorouço, Pedro
dc.contributor.authorAlves, Nuno
dc.contributor.authorMoura, Carla
dc.contributor.authorWang, Yadong
dc.contributor.authorJeffries, Eric
dc.contributor.authorGao, Jin
dc.contributor.authorSousa, Rita
dc.contributor.authorNeto, Lia Lucas
dc.contributor.authorCaldeira, Daniel
dc.contributor.authorSalvado, Francisco
dc.date.accessioned2025-10-29T13:45:54Z
dc.date.available2025-10-29T13:45:54Z
dc.date.issued2017-03-02
dc.description.abstractBackground: Preclinical trials are essential to test efficacious options to substitute the temporomandibular joint (TMJ) disk. The contemporary absence of an ideal treatment for patients with severe TMJ disorders can be related to difficulties concerning the appropriate study design to conduct preclinical trials in the TMJ field. These difficulties can be associated with the use of heterogeneous animal models, the use of the contralateral TMJ as control, the absence of rigorous randomized controlled preclinical trials with blinded outcomes assessors, and difficulties involving multidisciplinary teams. Objective: This study aims to develop a new, reproducible, and effective study design for preclinical research in the TMJ domain, obtaining rigorous data related to (1) identify the impact of bilateral discectomy in black Merino sheep, (2) identify the impact of bilateral discopexy in black Merino sheep, and (3) identify the impact of three different bioengineering TMJ discs in black Merino sheep. Methods: A two-phase exploratory randomized controlled preclinical trial with blinded outcomes is proposed. In the first phase, nine sheep are randomized into three different surgical bilateral procedures: bilateral discectomy, bilateral discopexy, and sham surgery. In the second phase, nine sheep are randomized to bilaterally test three different TMJ bioengineering disk implants. The primary outcome is the histological gradation of TMJ. Secondary outcomes are imaging changes, absolute masticatory time, ruminant time per cycle, ruminant kinetics, ruminant area, and sheep weight Results: Previous preclinical studies in this field have used the contralateral unoperated side as a control, different animal models ranging from mice to a canine model, with nonrandomized, nonblinded and uncontrolled study designs and limited outcomes measures. The main goal of this exploratory preclinical protocol is to set a new standard for future preclinical trials in oromaxillofacial surgery, particularly in the TMJ field, by proposing a rigorous design in black Merino sheep. The authors also intend to test the feasibility of pilot outcomes. The authors expect to increase the quality of further studies in this field and to progress in future treatment options for patients undergoing surgery for TMJ disk replacement. Conclusions: The study has commenced, but it is too early to provide results or conclusions.eng
dc.description.sponsorshipThis preclinical trial is supported by Faculdade de Medicina Veterinária da Universidade de Lisboa, Instituto Politécnico de Leiria (Centre for Rapid and Sustainable Product Development), Centro Hospitalar de Setúbal, Instituto de Medicina Molecular, Faculdade de Medicina da Universidade de Lisboa. The authors are grateful to Joaquim Ferreira from Lisbon Faculty of Medicine for study design; to Susan Smith from Institute of Bone and Joint Research-Northern Sydney Local Health District-Sydney Medical School Northern, Australia, for histological analysis; to Pedro Nunes from Radiology Department of Centro Hospitalar Lisboa Norte; to Miguel Virgílio for kinematics video recording; and to Joaquim Ângelo and Ermelinda Ângelo for animal logistics control. This study was granted by Portuguese Grunenthal Foundation and by Secção Regional Oeste da Ordem dos Médicos. This publication was supported by the Portuguese Foundation for Science and Technology (FCT) through the following projects: UID/Multi/04044/2013 and PTDC/EMS-SIS/7032/2014.
dc.identifier.citationDavid Faustino Ângelo, Florencio Gil Monje, Raúl González-García, Christopher B Little, Lisete Mónico, Mário Pinho, Fábio Abade Santos, Belmira Carrapiço, Sandra Cavaco Gonçalves, Pedro Morouço, Nuno Alves, Carla Moura, Yadong Wang, Eric Jeffries, Jin Gao, Rita Sousa, Lia Lucas Neto, Daniel Caldeira, Francisco Salvado, Bioengineered Temporomandibular Joint Disk Implants: Study Protocol for a Two-Phase Exploratory Randomized Preclinical Pilot Trial in 18 Black Merino Sheep (TEMPOJIMS), JMIR Research Protocols, Volume 6, Issue 3, 2017, ISSN 1929-0748, https://doi.org/10.2196/resprot.6779
dc.identifier.doi10.2196/resprot.6779
dc.identifier.issn1929-0748
dc.identifier.urihttp://hdl.handle.net/10400.8/14423
dc.language.isoeng
dc.peerreviewedyes
dc.publisherJMIR Publications Inc.
dc.relationCentre for Rapid and Sustainable Product Development
dc.relationBioMaTE - A novel bio-manufacturing system to produce bioactive scaffolds for tissue engineering
dc.relation.hasversionhttps://www.researchprotocols.org/
dc.relation.ispartofJMIR Research Protocols
dc.rights.uriN/A
dc.subjectTemporomandibular joint disorders (TMD)
dc.subjectTemporomandibular joint bioengineered disk implants
dc.subjectTemporomandibular randomized preclinical trial protocol
dc.titleBioengineered Temporomandibular Joint Disk Implants: Study Protocol for a Two-Phase Exploratory Randomized Preclinical Pilot Trial in 18 Black Merino Sheep (TEMPOJIMS)eng
dc.typejournal article
dspace.entity.typePublication
oaire.awardTitleCentre for Rapid and Sustainable Product Development
oaire.awardTitleBioMaTE - A novel bio-manufacturing system to produce bioactive scaffolds for tissue engineering
oaire.awardURIinfo:eu-repo/grantAgreement/FCT/6817 - DCRRNI ID/UID%2FMulti%2F04044%2F2013/PT
oaire.awardURIinfo:eu-repo/grantAgreement/FCT/9471 - RIDTI/PTDC%2FEMS-SIS%2F7032%2F2014/PT
oaire.citation.endPage10
oaire.citation.issue3
oaire.citation.startPage1
oaire.citation.titleJMIR Research Protocols
oaire.citation.volume6
oaire.fundingStream6817 - DCRRNI ID
oaire.fundingStream9471 - RIDTI
oaire.versionhttp://purl.org/coar/version/c_970fb48d4fbd8a85
person.familyNameÂngelo
person.givenNameDavid
person.identifier.ciencia-id2C1B-F1D5-5A08
person.identifier.orcid0000-0001-8411-9946
project.funder.identifierhttp://doi.org/10.13039/501100001871
project.funder.identifierhttp://doi.org/10.13039/501100001871
project.funder.nameFundação para a Ciência e a Tecnologia
project.funder.nameFundação para a Ciência e a Tecnologia
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