NCT03710174

Evaluation of the Effectiveness of Infrared LED Photobiomodulation in Children With Sleep Bruxism

Status unknown Phase 2 Last updated 18 October 2018

What this trial tests

Phase 2 trial testing Infrared LED photobiomodulation in Bruxism, Sleep in 20 participants. Status unknown.

Timeline

1 August 2017

Primary endpoint
1 August 2018

10 April 2019

Quick facts

Lead sponsor	University of Nove de Julho
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	20
Start date	1 August 2017
Primary completion	1 August 2018
Estimated completion	10 April 2019
Sites	1 location across Brazil

Drugs / interventions tested

• Infrared LED photobiomodulation
• Occlusal splint
• Placebo LED photobiomodulation

Conditions studied

• Bruxism, Sleep — all drugs for Bruxism, Sleep →

Sponsor

University of Nove de Julho

Who can join

Adults 7 to 10, any sex, with Bruxism, Sleep. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Sleep bruxism is a masticatory muscle activity characterized as rhythmic (phasic) or non-rhythmic (tonic). The literature reports the prevalence rates, diverse etiologies and different types of treatment. In children and adolescents, etiological factors, such as breathing pattern and sleep quality, have recently been addressed in studies investigating sleep bruxism. While studies have also reported psychological factors as a causal factor, this aspect requires further research. There are also divergences in opinion regarding the form of treatment. New therapies for adults, such as botulinum toxin, have been investigated, but such techniques are not applicable for individuals in the growth and development phase. Thus, photobiomodulation therapy has piqued the interest of researchers, as this noninvasive method has demonstrated positive results in problems related to muscle tissues. This document describes the protocol for a proposed study to evaluate morphological and psychosocial aspects in children and adolescents with awake bruxism and their responses to photobiomodulation therapy with infrared LED.

Publications & conference data

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

1. Evaluation of the effectiveness of infrared light-emitting diode photobiomodulation in children with sleep bruxism: Study protocol for randomized clinical trial.
   Kobayashi FY, Castelo PM, Gonçalves MLL, Motta LJ, et al · · 2019 · cited 7× · PMID 31567965 · DOI 10.1097/md.0000000000017193