NCT05297604

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

Completed NA Last updated 21 October 2024

What this trial tests

NA trial testing Vascular photobiomodulation (VPBM) in Temporomandibular Disorder in 56 participants. Completed in 10 November 2023.

Timeline

20 October 2022

Primary endpoint
20 June 2023

10 November 2023

Quick facts

Lead sponsor	University of Nove de Julho
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	56
Start date	20 October 2022
Primary completion	20 June 2023
Estimated completion	10 November 2023
Sites	1 location across Brazil

Drugs / interventions tested

• Vascular photobiomodulation (VPBM)
• Sham group (simulated vascular photobiomodulation)

Conditions studied

• Temporomandibular Disorder — all drugs for Temporomandibular Disorder →

Sponsor

University of Nove de Julho

Who can join

Adults 6 to 9, any sex, with Temporomandibular Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Vascular photobiomodulation in the treatment of children with temporomandibular disorders: Study protocol for a randomized, controlled, blind, clinical trial.
   Sertaje MRF, Gonçalves MLL, Gomes AO, Bruno LH, et al · · 2022 · cited 3× · PMID 36281107 · DOI 10.1097/md.0000000000031228