Temporomandibular disorder (TMD) refers to a group of musculoskeletal conditions that affect the temporomandibular joint (TMJ), the masticatory muscles as well as the associated structures. TMD is divided into two large groups of disorders, namely arthrogenic and myogenic TMD. There is a wide range of therapeutic modalities used in the management of TMD. The aim of this study protocol is to develop the core outcome sets (COS) for clinical trials in myogenic and/or arthrogenic temporomandibular disorders. The purpose of the study is to promote greater clarity in the results presented in these clinical trials. The use of the COS-TMD will reduce the risk of publication bias and will enable a proper comparison of results found by different studies. The use COS when planning and reporting clinical trials will simplify the determination of the effectiveness of different modalities of therapies used to treat TMD, with high-quality scientific evidence. This strategy will ultimately allow adequate therapeutic decision-making and allocation of health and research resources.
ContributorsFerreira, Natália1,3,4, Marto, Carlos Miguel 2; Oliveira, Aleli 3; Rodrigues, Maria João 1; DosSantos, Marcos Fábio 3,4*
Affiliations:
1 Instituto de Oclusão e Dor Orolfacial da Faculdade de Medicina da Universidade de Coimbra, Portugal.
2 Centro de Investigação em Genética e Oncobiologia (CIMAGO), Instituto de Investigação Clínica e Biomédica de Coimbra (iCBR), Universidade de Coimbra, Portugal.
3 Programa de Pós-Graduação em Radiologia, Faculdade de Medicina (FM), Universidade Federal do Rio de Janeiro (UFRJ)
4 Laboratório de Morfogênese Celular (LMC), Instituto de Ciências Biomédicas (ICB), Universidade Federal do Rio de Janeiro (UFRJ)
Disease Category: Dentistry & oral health
Disease Name: Temporomandibular Disorders
Age Range: 18 - 65
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Conference participants
- Consumers (patients)
- Researchers
- COS for clinical trials or clinical research
- Consensus meeting
- Delphi process
- Systematic review
The COS scope will be based on the PICO model (Population; Intervention; Comparison; Outcomes). An extensive literature search was performed, including the COMET database, and no article evaluating the outcomes in Temporomandibular Disorders was found. Thus, this work will be based on the following scope:
Participants:
1- Individuals diagnosed with Temporomandibular Dysfunction of muscular origin (masticatory muscle disorders), regardless of the severity of the dysfunction or the diagnoses contained within the masticatory muscle disorders.
2- Individuals diagnosed with intra-articular Temporomandibular Disorders, regardless of the severity of the dysfunction or type of diagnosis.
Intervention: any therapeutic modality used in the management of myofascial TMDs will be considered, including conservative and minimally invasive.
Comparison: studies using a placebo, or another form of therapy will be considered for inclusion
The identification of outcomes will be carried out through a systematic review wherein randomized clinical trials that evaluated the effectiveness of interventions used in the management of TMD will be included.
The list of outcomes from the systematic review will be evaluated by groups of key stakeholders to identify the existence of relevant outcomes that are not included in the initial list. At this stage, three stakeholder groups will be formed. They will be composed by a representative sample of each group involved in the development of the TMD-COS, namely: health professionals; researchers; and patients.