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

University of Nove de Julho

Status and phase: Unknown; Phase 2

Conditions: Bruxism, Sleep

Treatments: Radiation: Infrared LED photobiomodulation; Device: Occlusal splint; Radiation: Placebo LED photobiomodulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03710174

ferbruxismo

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 7 to 10 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• mixed dentition phase (permanent incisors and molars erupted)
• established permanent dentition.

Exclusion criteria

• dental caries
• using medications, such as anti-inflammatory agents, muscle relaxants, corticoids, anticonvulsants and antidepressants
• those with chronic diseases that affect muscles or motor coordination
• those who do not cooperate during the evaluation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

20 participants in 4 patient groups, including a placebo group

Control group

No Intervention group

Description:

Without bruxism and no intervention. They will be submitted to electromyographic assessment and evaluation of salivary cortisol and dopamine.

LED group

Experimental group

Description:

The volunteers in Group 2 will be submitted to the initial evaluation of the morphological and psychosocial variables. During the same appointment, red LED (3 X 6 cm) will be administered using a board with 6 LEDs with a wavelength of 650 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. They will be submitted before and after LED to electromyographic assessment and evaluation of salivary cortisol and dopamine.

Treatment:

Radiation: Infrared LED photobiomodulation

Occlusal splint group

Experimental group

Description:

They will be treated using the standard protocol of a rigid 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.

Treatment:

Device: Occlusal splint

Placebo group

Placebo Comparator group

Description:

Subjects with bruxism. The same procedures as LED group, but the device will be turn off.

Treatment:

Radiation: Placebo LED photobiomodulation