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

Primary Purpose

Bruxism, Sleep

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Infrared LED photobiomodulation
Occlusal splint
Placebo LED photobiomodulation
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bruxism, Sleep

Eligibility Criteria

7 Years - 10 Years (Child)All SexesAccepts 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

Sites / Locations

  • UninoveRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Placebo Comparator

Arm Label

Control group

LED group

Occlusal splint group

Placebo group

Arm Description

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

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.

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in salivary cortisol and dopamine
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.

Full Information

First Posted
October 15, 2018
Last Updated
October 15, 2018
Sponsor
University of Nove de Julho
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1. Study Identification

Unique Protocol Identification Number
NCT03710174
Brief Title
Evaluation of the Effectiveness of Infrared LED Photobiomodulation in Children With Sleep Bruxism
Official Title
Evaluation of the Effectiveness of Infrared LED Photobiomodulation in Children With Sleep Bruxism: Study Protocol for Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
April 10, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bruxism, Sleep

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The outcome assessor will not know to which group the participants belong.
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Without bruxism and no intervention. They will be submitted to electromyographic assessment and evaluation of salivary cortisol and dopamine.
Arm Title
LED group
Arm Type
Experimental
Arm 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.
Arm Title
Occlusal splint group
Arm Type
Experimental
Arm 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.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Subjects with bruxism. The same procedures as LED group, but the device will be turn off.
Intervention Type
Radiation
Intervention Name(s)
Infrared LED photobiomodulation
Intervention Description
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
Device
Intervention Name(s)
Occlusal splint
Intervention Description
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
Radiation
Intervention Name(s)
Placebo LED photobiomodulation
Intervention Description
The same procedure as LED group with the device turned off.
Primary Outcome Measure Information:
Title
Change in muscle activity evaluated by electromyography
Description
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.
Time Frame
Before and immediately after treatment
Secondary Outcome Measure Information:
Title
Change in salivary cortisol and dopamine
Description
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.
Time Frame
Before and immediately after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Uninove
City
São Paulo
State/Province
SP
ZIP/Postal Code
01504-001
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernanda Kobayashi
Phone
+55 11 3385 9010
Email
fernandaykobayashi@gmail.com

12. IPD Sharing Statement

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

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