Prognostic factor analysis in patients with temporomandibular disorders after reversible treatment: study protocol for a prospective cohort study in China.

Introduction: Temporomandibular disorders (TMDs) are complex multifactorial disorders. Reversible treatment has been suggested for the initial management of TMD; however, comparable therapeutic effects of different reversible intervention modalities remain controversial. Various biopsychosocial factors, which may be putative prognostic factors that influence the response to reversible treatment for TMD, have been reported to increase the risk of developing first-onset TMD. However, there is a paucity of research that aims to identify prognostic factors associated with the clinical outcomes of reversible treatment in people with TMD. The objective of this prospective cohort study is to identify prognostic factors that are associated with clinical outcomes of reversible treatment in patients with TMD and to analyse the risk factors that influence the development of chronic TMD.

Methods And Analysis: We plan to recruit 834 patients with TMD who meet the inclusion criteria. Once informed consent is obtained, baseline data, including anamnestic data, physical assessments and self-report questionnaires, will be collected from participants at their first clinic visit; subsequently, they will receive 1-4 weeks of reversible treatment. The primary treatment outcome measures will be a change in the anterior maximum mouth opening, worsening of TMD pain scores assessed using a visual analogue scale (VAS) and a reduction in characteristic pain intensity. A good outcome will be defined as an anterior maximal opening ≥35 mm and at least a 30% reduction in VAS scores 3 months after baseline. The association between candidate prognostic factors and clinical outcomes of reversible TMD treatment will be analysed.

Ethics And Dissemination: The protocol has been approved by the Ethics Committee of Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China, based on the guidelines outlined in the Declaration of Helsinki (SH9H-2019-T316-4). The results of this study will be reported in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology statement. The authors intend to publish the results in a peer-reviewed journal.

Trial Registration Number: ChiCTR2000033328.