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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05297604
Enrollment
56
Registered
2022-03-28
Start date
2022-10-20
Completion date
2023-11-10
Last updated
2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temporomandibular Disorder

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.

Interventions

RADIATIONVascular 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.

RADIATIONSham group (simulated vascular photobiomodulation)

Simulated radiation. The participants received a single session.

Sponsors

University of Nove de Julho
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Participants in the placeb group will be treated in the same way as the active laser group. The person in charge of the application will simulate the irradiation with the equipment kept off, so that the participant does not identify the group to which he/she belongs to, and the device activation sound (beep) will be turned on at the time of application.

Eligibility

Sex/Gender
ALL
Age
6 Years to 9 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
Changes in Pain EvaluationBaseline 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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026