Photobiomodulation in Temporomandibular Disorder

Study Overview
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Brief Summary
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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 Description
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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.

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

Conditions
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Pain, Temporomandibular Disorder

Intervention / Treatment
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* Device: Low-intensity laser
* Device: occlusal plates
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: people between 15 and 25 years diagnosis of TMD in group I Exclusion Criteria: Individuals with dental-facial anomalies orthodontic or orthopedic treatment Individuals who were taking muscle relaxants or anti-inflammatory medications

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: It is a prospective trial of clinical and economic analysis. It will include 45 patients to evaluate the effectiveness of the treatments with low-intensity laser and occlusal plate for muscle pain in patients with TMD
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-intensity laser<br>Twelve laser applications will be applied as initial treatment, with 2 sessions per week. A wave length of 780 nm, with an energy density of 25 J/cm2, a power of 50 mW and power density of 1.25 W/cm2, will be used for a duration of 20 seconds per point, resulting in a total energy of 1J per point. The laser will be applied at each point, using a conventional tip in contact with the skin, thus considering an area of 0.04 cm2, in accordance with the protocol suggested by Venezian et al. (2010) and Carvalho et al. (2010). The laser will be applied to 3 points of the masseter muscle (upper, middle, and lower bundles) and 1 point in the anterior temporalis on each side of the face | Device: Low-intensity laser<br>* Laser applications will be applied as initial treatment, with 2 sessions per week. A wave length of 780 nm, with an energy density of 25 J/cm2, a power of 50 mW and power density of 1.25 W/cm2, will be used for a duration of 20 seconds per point, resulting in a total energy of 1J per point. The laser will be applied at each point, using a conventional tip in contact with the skin, thus considering an area of 0.04 cm2<br>Device: Placebo<br>* For the placebo group, all the measures described for the group 1 (LIL) will be adopted, however the laser equipment will remain switched off.<br>|
| Active Comparator: Occlusal Plate<br>The group undergoing treatment with occlusal plates will be instructed to use the device during sleep, 8 hours per night, for a period of 12 months. The plates will be made following the principles established by Okenson (1998). Participants will be molded with alginate to obtain models. In the upper model, a 2 mm acetate plate will be made, to be later replaced with acrylic resin (STRINI et al., 2009), and these plates will be adjusted in centric relation, to promote occlusal stability and disocclusion guide. Weekly follow-up and adjustments will be performed during the evaluation period, until the completion of treatment | Device: occlusal plates<br>* The group undergoing treatment with occlusal plates will be instructed to use the device during sleep, 8 hours per night, for a period of 12 months. The plates will be made following the principles established by Okenson (1998). Participants will be molded with alginate to obtain models. In the upper model, a 2 mm acetate plate will be made, to be later replaced with acrylic resin (STRINI et al., 2009), and these plates will be adjusted in centric relation, to promote occlusal stability and disocclusion guide. Weekly follow-up and adjustments will be performed during the evaluation period, until the completion of treatment<br>Device: Placebo<br>* For the placebo group, all the measures described for the group 1 (LIL) will be adopted, however the laser equipment will remain switched off.<br>|
| Placebo Comparator: Placebo<br>For the placebo group, all the measures described for the group 1 (LIL) will be adopted, however the laser equipment will remain switched off. | Device: Placebo<br>* For the placebo group, all the measures described for the group 1 (LIL) will be adopted, however the laser equipment will remain switched off.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Muscle pain will be analyzed by clinical criteria of the Research Diagnostic Criteria for Temporomandibular Disorders | 12 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-effectviness | 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. | 12 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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temporomandibular disorder, photobiomodulation, pain