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

NCT06859138 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2025-05-04

No results posted yet for this study

Summary

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 myofascial TMD.

Conditions

  • Temporomandibular Disorders (TMD)

Interventions

OTHER

Manual Therapy

Manual therapy techniques including massage, trigger point pressure, muscle stretching and joint mobilization.

OTHER

Splint therapy

Dental splint used for temotoromandibular disorders treatment

Sponsors & Collaborators

  • University of Jaén

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-06
Primary Completion
2025-04-30
Completion
2025-04-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06859138 on ClinicalTrials.gov