Clinical Trial: Photobiomodulation in Temporomandibular Disorder

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Photomodulation in the Treatment of Pain in Patients With Tmd: Analysis of Cost-effectiveness.

Brief Summary: The general purpose of this project is to evaluate the cost-effectiveness of LIL treatment and occlusal plates in the treatment of pain in patients between 15 and 25 years of age with TMD.

Detailed Summary: Temporomandibular disorder (TMD) affects a significant portion of the population. Epidemiological data show that the signs and symptoms of TMD start to become apparent from six years of age, and in adolescence these signs and symptoms are similar to those of adults. The painful conditions of TMD can affect the quality of life of young patients, compromising the daily activities of these individuals. The present project aims (1) to estimate the direct costs of treatment of muscle pain in patients with TMD with low-intensity laser and with occlusal plate and a placebo group; (2) to evaluate the effectiveness of the treatments with low-intensity laser and occlusal plate for muscle pain in patients with TMD; (3) to analyze the cost-effectiveness of the two proposed treatments for pain; and (4) to describe and compare the results of analyses of treatments for pain in patients with TMD. The study will be conducted at the Odontological Clinic of Universidade Nove de Julho. It is a prospective trial of clinical and economic analysis. It will include 30 patients aged between 15 and 25 years with TMD, randomly assigned to a treatment group: G1 (low-power laser), G2 (occlusal plate) and G3 (placebo). The analysis will be based on the direct costs of each treatment during the 12-month period, estimating the cost of each treatment. The outcome for the analysis of the effectiveness will be the pain, measured periodically by means of the clinical examination of the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). The cost-effectiveness ratio will be calculated using, as endpoints, pain and the calculation of the ratio between the difference in costs between the groups studied. The evaluation of the impact of the treatment on quality of life will be determined by applying the adapted EuroQol-5D.
Sponsor: University of Nove de Julho

Current Primary Outcome: Pain [ Time Frame: 12 months after treatment ]

Muscle pain will be analyzed by clinical criteria of the Research Diagnostic Criteria for Temporomandibular Disorders


Original Primary Outcome: Same as current

Current Secondary Outcome: Cost-effectviness [ Time Frame: 12 months after treatment ]

This phase of the study will consist in the quantification of resources, i.e. determining the frequency of use of resources and materials during the treatment. The units used to quantify the direct costs consumed are physical units such as consultation time, number of sessions, equipment used, and materials consumed. These data will be collected using a specific form.


Original Secondary Outcome: Same as current

Information By: University of Nove de Julho

Dates:
Date Received: March 9, 2017
Date Started: May 2, 2017
Date Completion: May 2, 2018
Last Updated: March 23, 2017
Last Verified: March 2017