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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Temporomandibular Disorder
• Intervention / Treatment: Radiation: Non-Invasive Intravascular Laser Irradiation Of Blood; Radiation: Placebo application of laser

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Composed of individuals who will not receive any type of intervention.
Active Comparator: Non-Invasive Intravascular Laser Irradiation Of Blood Group; 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; 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.
Placebo Comparator: Placebo group; 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; Simulated radiation. One session will be performed.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: University of Nove de Julho

Publications and helpful links

General Publications

• Sertaje MRF, Goncalves MLL, Gomes AO, Bruno LH, Fossati AL, Viarengo NO, Santos EM, Sobral APT, Mesquita-Ferrari RA, Fernandes KPS, Horliana ACRT, Motta LJ, Bussadori SK. Vascular photobiomodulation in the treatment of children with temporomandibular disorders: Study protocol for a randomized, controlled, blind, clinical trial. Medicine (Baltimore). 2022 Oct 21;101(42):e31228. doi: 10.1097/MD.0000000000031228.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 20, 2023
• Primary Completion (Anticipated): June 20, 2024
• Study Completion (Anticipated): December 10, 2024

Study Registration Dates

• First Submitted: March 16, 2022
• First Submitted That Met QC Criteria: March 16, 2022
• First Posted (Actual): March 28, 2022

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
• Other Study ID Numbers: TMDChildren

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No