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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)

2017-03Journal article Open access
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dc.contributor.authorÂngelo, David Faustino
dc.contributor.authorMonje, Florencio Gil
dc.contributor.authorGarcía-González, 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.accessioned2020-07-31T11:36:54Z
dc.date.available2020-07-31T11:36:54Z
dc.date.issued2017-03
dc.descriptionUnder the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.pt_PT
dc.description.abstract"Background: 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.pt_PT
dc.description.abstractObjective: 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.pt_PT
dc.description.abstractMethods: 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.pt_PT
dc.description.abstractResults: 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.pt_PT
dc.description.abstractConclusions: The study has commenced, but it is too early to provide results or conclusions."pt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.citationÂngelo DF, Monje FG, González-García R, Little CB, Mónico L, Pinho M, Santos FA, Carrapiço B, Gonçalves SC, Morouço P, Alves N, Moura C, Wang Y, Jeffries E, Gao J, Sousa R, Neto LL, Caldeira D, Salvado F Bioengineered Temporomandibular Joint Disk Implants: Study Protocol for a Two-Phase Exploratory Randomized Preclinical Pilot Trial in 18 Black Merino Sheep (TEMPOJIMS) JMIR Res Protoc 2017;6(3):e37 DOI: 10.2196/resprot.6779pt_PT
dc.identifier.doi10.2196/resprot.6779pt_PT
dc.identifier.issn1929-0748
dc.identifier.urihttp://hdl.handle.net/10400.26/33027
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.publisherJMIR Publicationspt_PT
dc.relation.publisherversionhttps://doi.org/10.2196/resprot.6779pt_PT
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/pt_PT
dc.subjectTemporomandibular joint bioengineered disk implantspt_PT
dc.subjectTemporomandibular joint disorderspt_PT
dc.subjectTemporomandibular randomized preclinical trial protocolpt_PT
dc.titleBioengineered temporomandibular joint disk implants: study protocol for a two-phase exploratory randomized preclinical pilot trial in 18 black merino sheep (TEMPOJIMS)pt_PT
dc.typejournal article
dspace.entity.typePublication
oaire.citation.startPageE37pt_PT
oaire.citation.titleJMIR Research Protocolspt_PT
oaire.citation.volume6(3)pt_PT
rcaap.rightsopenAccesspt_PT
rcaap.typearticlept_PT

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