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

University of Nove de Julho

Status: Completed

Conditions: Temporomandibular Disorder

Treatments: Radiation: Vascular photobiomodulation (VPBM); Radiation: Sham group (simulated vascular photobiomodulation)

Study type: Interventional

Funder types: Other

Identifiers

NCT05297604

TMDChildren

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 6 to 9 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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56 participants in 2 patient groups, including a placebo group

VPBM group (vascular photobiomodulation)

Active Comparator group

Description:

The participants received a single session of VPBM.

Treatment:

Radiation: Vascular photobiomodulation (VPBM)

Sham group (simulated vascular photobiomodulation)

Placebo Comparator group

Description:

The participants received the same treatment as the VPBM group, but the equipment was switched off. To ensure blinding, the sound of the device (beep) was activated at the time of simulated PBM using a telephone.

Treatment:

Radiation: Sham group (simulated vascular photobiomodulation)