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Effects of Occlusal Splint vs Occlusal Splint Added to Manual Therapy in Patients With Temporomandibular Disorders

University of Jaén · 2025
ClinicalTrials.gov · Datasets · License: Public Domain · 2025
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A randomized clinical trial evaluates physiotherapy plus splint treatment versus conventional splint treatment in patients with myofascial-origin temporomandibular disorder (TMD). The study follows the ethical principles of the Declaration of Helsinki and has been approved by the Research Ethics Committee of the University of Jaén. Methodology Participants, recruited from three dental clinics in Spain, must be adults diagnosed with TMD according to the Diagnostic Criteria for Temporomandibular Disorder (DC/TMD). Patients with health conditions that could hinder participation are excluded. They are randomly assigned to two groups: one receiving physiotherapy plus a splint, and the other receiving only a splint. The sample size was calculated using G\*Power, determining that at least 38 patients (19 per group) are required. Assessments and Measurements Sociodemographic variables include age, sex, BMI, education level, and lifestyle habits. Various instruments are used to assess TMD and pain, such as the DC/TMD, the Fonseca Anamnestic Index, the Numerical Pain Rating Scale, and the Neck Disability Index. Intervention Physiotherapy + splint group: Four 20-minute manual therapy sessions, including techniques for the temporomandibular joint and cervical muscles. Splint-only group: Only splint use as prescribed by the dentist. Assessments are conducted before and after treatment for the physiotherapy group and at two time points for the splint-only group (before splint placement and one month later). Data Analysis SPSS and MedCalc software will be used, with a 95% confidence level. Relationships will be analyzed through regression and Pearson correlation, and group comparisons will be performed using repeated measures ANOVA, Student's t-test, and Chi-square test. Effect size will be calculated using Cohen's d. In conclusion, the study aims to determine the effectiveness of combined physiotherapy and splint treatment compared to splint-only treatment in patients with
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