Non-Invasive Intravascular Laser Irradiation Of Blood In The Treatment Of Children With Temporomandibular Disorders

Study Overview
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Brief Summary
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This study, which will be blind, randomized controlled, will be carried out on children between 6 and 9 years of age, at the Catholic University of Uruguay, Faculty of Health Sciences, Postgraduate School, and surrounding schools. Patients who present temporomandibular disorders, based on the diagnostic criteria will be the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) will be included. The laser to be used is infrared, power 100 mW ±20%, wavelength 660nm ±10 nm, energy parameter 60J, continuous application. The technique is not invasive, the irradiation point is by continuous and direct transcutaneous application to the radial artery by means of a bracelet that inserts the laser beam. One session will be performed. There will be a laser group, a placebo group and a control group. Participants in all groups will be re-evaluated at the end, following the same evaluation procedures used initially, evaluating the effects of ILIB on pain and range of motion.

Official Title
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Non-Invasive Intravascular Laser Irradiation Of Blood In The Treatment Of Children With Temporomandibular Disorders - Study Protocol For A Randomized, Controlled, Blind, Clinical Trial

Conditions
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Temporomandibular Disorder

Intervention / Treatment
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* Radiation: Non-Invasive Intravascular Laser Irradiation Of Blood
* Radiation: Placebo application of laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: have a complete dentition (except third molars); present mandibular deviation and/or deflection. Exclusion Criteria: Patients with craniofacial anomalies, genetic syndromes since this is due to the fact that people with anomalies of this type are more likely to suffer from TMD due to other factors associated with their malformation, which would be a confounding variable for this study. Patients presenting occlusal changes; make use of any type of dental prosthesis; be undergoing orthodontic treatment or need orthognathic surgery or physical therapy; since it would alter the results of both diagnosis and treatment. Patients undergoing cancer treatment: because it is necessary that patients do not have any condition that alters their general health, since this may cause a different response to the proposed treatment. Patients who start using any type of medication during any phase of the study because it may cause a different response to the proposed treatment. Patients with photosensitivity since it will not be possible to apply part of the treatment.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Non-Invasive Intravascular Laser Irradiation Of Blood Group<br>Participants in this group will receive low-intensity laser that is attached to a bracelet that has been developed so that the light beam is transported transcutaneously over the radial artery. | Radiation: Non-Invasive Intravascular Laser Irradiation Of Blood<br>* Participants will receive the treatment for 20 minutes. The laser to be used is infrared-red, power 100 mW ±20%, wavelength 660nm ±10 nm, energy parameter 60J, continuous application. The technique is not invasive, the irradiation point is by continuous and direct transcutaneous application to the radial artery by means of a bracelet that inserts the laser beam. One session will be performed.<br>|
| Placebo Comparator: Placebo group<br>Participants will be treated in the same way as the active group. The person in charge of the ILIB application will simulate the irradiation with the equipment kept off, so that the participant does not identify the group to which he belongs, and the device activation sound (beep) will be turned on at the time of application. | Radiation: Placebo application of laser<br>* Simulated radiation. One session will be performed.<br>|
| No Intervention: Control group<br>Composed of individuals who will not receive any type of intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the Diagnosis of Temporomandibular Disorders | The Diagnostic Criteria Questionnaire for Temporomandibular Disorders - DC/TMD will be applied before and after treatment. | Baseline and one week after treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Pain Evaluation | Pain will be evaluated using the visual analog scale (VAS). The children will be asked to to mark the intensity of the pain on a corresponding linear scale from 0 to 10, taking 0 without pain and 10 extreme pain. | Baseline and one week after treatment. |