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

October 15, 2018 updated by: Fernanda Yukie Kobayashi, University of Nove de Julho

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control group
Without bruxism and no intervention. They will be submitted to electromyographic assessment and evaluation of salivary cortisol and dopamine.
Experimental: 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.
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.
Experimental: 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.
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.
Placebo Comparator: Placebo group
Subjects with bruxism. The same procedures as LED group, but the device will be turn off.
Radiation: Placebo LED photobiomodulation
The same procedure as LED group with the device turned off.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in muscle activity evaluated by electromyography
Time Frame: Before and immediately after treatment
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in salivary cortisol and dopamine
Time Frame: Before and immediately after treatment
The participants and caregivers will receive verbal and written instructions to avoid any physical activity, the ingestion of substances with alcohol or caffeine, soft drinks, tea, corticoids and chewing gum in the 24h prior to the collection of the saliva. Saliva samples will be collected using swabs, which will refrigerated immediately after collection. The swab will be placed under the tongue. Samples with visible signs of blood will be discarded due to possible contamination. The swabs will be centrifuged at 3500 rpm for 5 minutes. The supernatant will be collected and stored at -40o C. Cortisol will be determined using an enzyme-linked immunosorbent assay. Dopamine will also be determined using an ELIZA kit. The samples will be thawed and centrifuged again. The procedure will follow the basic ELISA principle of competition between an untagged antigen and an enzyme-tagged antigen for a particular number of binding sites on the antibody.
Before and immediately after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Nove de Julho

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 10, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 15, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ferbruxismo

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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