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

Not Applicable

Completed

• Conditions: Temporomandibular Disorder
• Interventions: Radiation: Placebo application of laser; Radiation: Non-Invasive Intravascular Laser Irradiation Of Blood

• Registration Number: NCT05297604
• Lead Sponsor: University of Nove de Julho

Brief Summary

This study is blind, randomized controlled and have been 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) were included. The laser used was 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 has been performed. There was a laser group, a placebo group. Participants in all groups were re-evaluated after the procedure, following the same evaluation procedures used initially, evaluating the effects of ILIB on pain and range of motion.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-16
• Study First Submitted QC: 2022-03-16
• Study First Posted: 2022-03-28
• Study Start: 2022-10-20
• Primary Completion: 2023-06-20
• Study Completion: 2023-11-10
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Healthy participants (ASA I) age six to nine years with diagnosis of TMD in the mixed dentition phase and with jaw deviation and/or deflection. Deviation is defined as the jaw following a deviated path to one side during opening. Deflection is defined as the jaw following a deviated path without returning to the midline when the mouth is fully opened.

Exclusion Criteria

• Craniofacial anomalies or genetic syndromes due to the greater probability of the development of TMD associated with the malformation, which could be a confounding variable, malocclusion, use of a dental prosthesis, currently undergoing orthodontic treatment, need for orthognathic surgery or physical therapy due to the potential impact on the results of both the diagnosis and treatment, currently undergoing oncological treatment due to the need to avoid conditions that may exert an influence on the response to the proposed treatment and photosensitivity due to the incompatibility with part of the proposed treatment. Individuals on medications could be included and the medications needed to be recorded in the results.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo application of laser	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.
Non-Invasive Intravascular Laser Irradiation Of Blood Group	Non-Invasive Intravascular Laser Irradiation Of Blood	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.

Primary Outcome Measures

Name	Time	Method
Change in mouth opening range of motion (following clinical protocol of DC/TMD)	Baseline and immediately after the procedure.	Vertical movement of the jaw was measured using calibrated digital calipers.

Secondary Outcome Measures

Name	Time	Method
Changes in Pain Evaluation	Baseline and immediately after the procedure.	Pain was assessed using the VAS, which is an instrument for the subjective assessment of pain. The subject makes a mark along a horizontal line with 0 (absence of pain) printed at one end and 10 (extreme pain) printed at the other end. The patient's mark on the line is recorded in the clinical history for reproduction among observers.

Trial Locations

Locations (1)

Universidade Nove de Julho; 🇧🇷 São Paulo, SP, Brazil