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 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.

Study Overview

• Status: Completed
• Conditions: Temporomandibular Disorder
• Intervention / Treatment: Radiation: Vascular photobiomodulation (VPBM); Radiation: Sham group (simulated vascular photobiomodulation)

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 01525-000
      • Universidade Nove de Julho

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: VPBM group (vascular photobiomodulation); The participants received a single session of VPBM.	Radiation: Vascular photobiomodulation (VPBM); The participants received a 20-minute single session of VPBM. This noninvasive method involves the use of low-power laser coupled to a bracelet designed to transport the light beam transcutaneously over the radial artery. The laser device (DMC Therapy Ec) delivered irradiation with a power of 100 ± 20 mW, wavelength of 660 ± 10 nm (red light) and energy of 120 J applied continuously, with irradiance of 35 W/cm².
Placebo Comparator: Sham group (simulated vascular photobiomodulation); 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.	Radiation: Sham group (simulated vascular photobiomodulation); Simulated radiation. The participants received a single session.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Pain Evaluation	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.	Baseline and immediately after the procedure.

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 (Actual): October 20, 2022
• Primary Completion (Actual): June 20, 2023
• Study Completion (Actual): November 10, 2023

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): October 21, 2024
• Last Update Submitted That Met QC Criteria: October 16, 2024
• Last Verified: October 1, 2024

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