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

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03710174
Enrollment
20
Registered
2018-10-18
Start date
2017-08-01
Completion date
2019-04-10
Last updated
2018-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bruxism, Sleep

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.

Interventions

RADIATIONInfrared 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.

DEVICEOcclusal 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.

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

Sponsors

University of Nove de Julho
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The outcome assessor will not know to which group the participants belong.

Eligibility

Sex/Gender
ALL
Age
7 Years to 10 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in muscle activity evaluated by electromyographyBefore and immediately after treatmentElectromyography 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

MeasureTime frameDescription
Change in salivary cortisol and dopamineBefore and immediately after treatmentThe 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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026