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

NCT ID: NCT03710174

Last Updated: 2018-10-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2019-04-10

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

LED group

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.

Group Type: EXPERIMENTAL

Infrared LED photobiomodulation

Intervention Type: 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.

Occlusal splint group

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.

Group Type: EXPERIMENTAL

Occlusal splint

Intervention Type: 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.

Placebo group

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

Group Type: PLACEBO_COMPARATOR

Placebo LED photobiomodulation

Intervention Type: RADIATION

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

Interventions

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.

Intervention Type: RADIATION

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.

Intervention Type: DEVICE

Placebo LED photobiomodulation

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

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Fernanda Yukie Kobayashi

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Uninove

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Facility Contacts

Fernanda Kobayashi

Role: primary

fernandaykobayashi@gmail.com

+55 11 3385 9010

Other Identifiers

ferbruxismo

Identifier Type: -

Identifier Source: org_study_id