NCT03710174

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

Evaluation of the Effectiveness of Infrared LED Photobiomodulation in Children With Sleep Bruxism: Study Protocol for Randomized Clinical Trial.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Nove de Julho · Academic / Other
• Sex: All
• Age: 7 Years – 10 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2017-08-01
• Primary completion: 2018-08-01
• Completion: 2019-04-10
• First posted: 2018-10-18
• Last updated: 2018-10-18

Locations

1 site across 1 country: Brazil