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

NCT03710174 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-10-18

No results posted yet for this study

Summary

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.

Conditions

  • Bruxism, Sleep

Interventions

RADIATION

Infrared LED photobiomodulation

Infrared LED (3 X 6 cm) will be administered using a board with 6 LEDs with a wavelength of wavelength: 850 nm ± 20 nm, seven-minute operation time, optical spot of 5 ± 2 mm and optical output of 2\~5 mW, with a dose of 2.675 J/cm2. Further analyses will be performed immediately after the photobiomodulation session and one week later.

DEVICE

Occlusal splint

After the initial evaluation, molds will be made for the fabrication of the splints, which will be delivered one week later. Written and verbal instructions for use will be given. After one month of daily use, the volunteers will return for the final morphological and psychosocial evaluations.

RADIATION

Placebo LED photobiomodulation

The same procedure as LED group with the device turned off.

Sponsors & Collaborators

  • University of Nove de Julho

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2018-08-01
Completion
2019-04-10

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03710174 on ClinicalTrials.gov