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

NCT03710174 | Unknown Phase 2

• 1 other identifier: ferbruxismo
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in muscle activity evaluated by electromyography

  Electromyography will be performed to complement the evaluation of the morphological aspects of the groups. The masseter and temporal muscles will be evaluated using a portable electromyograph (BTS TMJOINT) with wireless electrodes. The participant will be seated with Camper's plane parallel to the floor. Three readings will be made on both sides with the muscles at rest, during habitual maximum intercuspation (isometric contraction) and during simulated chewing with Parafilm (isotonic contraction). The signal will be captured for 10 seconds under each condition. The first chewing cycle will be discarded and the subsequent five cycles will be collected.

  Before and immediately after treatment

Secondary Outcomes (1)

• Change in salivary cortisol and dopamine

  Before and immediately after treatment

Study Arms (4)

Control group

NO INTERVENTION

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

LED group

EXPERIMENTAL

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.

Radiation: Infrared LED photobiomodulation

Occlusal splint group

EXPERIMENTAL

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.

Device: Occlusal splint

Placebo group

PLACEBO COMPARATOR

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

Radiation: Placebo LED photobiomodulation

Interventions

Infrared LED photobiomodulation RADIATION

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.

LED group

Occlusal splint DEVICE

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.

Occlusal splint group

Placebo LED photobiomodulation RADIATION

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

Placebo group

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Uninove

São Paulo, São Paulo, 01504-001, Brazil

RECRUITING

MeSH Terms

Conditions

Sleep Bruxism

Interventions

Occlusal Splints

Condition Hierarchy (Ancestors)

Bruxism; Tooth Diseases; Stomatognathic Diseases; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will not know to which group the participants belong.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: October 18, 2018
• Study Start: August 1, 2017
• Primary Completion: August 1, 2018
• Study Completion: April 10, 2019
• Last Updated: October 18, 2018

Record last verified: 2018-10

Locations

BR (1)