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Effects of Photobiomodulation in Children With Down Syndrome and Possible Sleep Bruxism

Effects of Photobiomodulation in Children With Down Syndrome and Possible Sleep Bruxism: Protocol For A Randomized, Controlled, Blind, Clinical Trial

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04211870
Enrollment
19
Registered
2019-12-26
Start date
2022-03-20
Completion date
2024-07-20
Last updated
2024-11-19

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

Conditions

Sleep Bruxism

Brief summary

The main characteristic of an individual with Trisomy 21 (T21), commonly known as Down Syndrome (DS), is muscular hypotonia, a characteristic that mainly affects the masticatory and oropharyngeal muscles, resulting in impairments in speech, swallowing, breathing and chewing, in addition to pain, noise and/or degeneration in the temporomandibular joints (TMJ), therefore, developing bruxism. The gold standard for the treatment and control of bruxism is the rigid plate, however, there is difficulty in developing treatment in children and adolescents with T21, therefore, photobiomodulation is a non-invasive intervention alternative already consolidated as an excellent option for modulation in muscle tissues. This study sought to evaluate the efficacy and safety of non-invasive intervention with red LED clusters for the control of bruxism in children and adolescents diagnosed with Down Syndrome. The present study is characterized as a pilot study, composed of individuals of both sexes, aged 4 to 17 years old, attended at the UNINOVE integrated health clinic and diagnosed with Down syndrome and bruxism. The treatment was carried out in a total of four sessions, one session per week, where in each session the LED plates were applied and post-application electromyographic collection was carried out.

Interventions

RADIATIONLED clusters

Each LED board contains six (6) LEDs with a wavelength of 660nm and a duration of seven (7) minutes in each muscle. The treatment was carried out in a total of four (4) sessions, one (1) session per week.

Sponsors

University of Nove de Julho
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
No

Inclusion criteria

* Children and adolescents with a diagnosis of Down syndrome * Four to 17 years of age * Bruxism, based on parental reports of the occurrence of grinding the teeth, incisal and/or occlusal tooth wear following the criteria of the American Academy of Sleep Medicine (AASM) and the questionnaire for the evaluation of bruxism validated by Serra Negra et al. (2014) and a systematic review performed by Manfredini et al. (2013).

Exclusion criteria

* Use of muscle relaxant * Temporomandibular disorder * Undergoing other therapy for bruxism * Other associated neurological diseases * Cognitive deficit that impedes understanding the evaluations.

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of electromyography of masticatory musclesBaseline and immediately after each the procedure.The activation of the masseter muscles (right and left) and anterior temporalis (right and left) has analyses of electrical activities that were collected by means of the BTS TMJOINT electromyograph from BTS Engineering with 6 channels, 4 of which are used, containing a bioelectric signal amplifier, wireless data transmission (wireless system) and disposable bipolar surface electrodes (Ag/AgCl - Medical Trace®) with 10 mm in diameter. The EMG signal was amplified with a gain of 2000 times and filtered within a frequency of 20-450 Hz. The impedance and common rejection mode of the equipment are \>1015 Ω//0.2 pF and 60/10Hz 92 dB.

Secondary

MeasureTime frameDescription
Orofacial Evaluation Through NOT-S (score from 0 to 12)Baseline and immediately after each the procedure.The following functions are addressed during the interview: (I) sensory function, (II) breathing, (III) habits, (IV) chewing and swallowing, (V) drooling and (VI) dryness of the mouth. The following functions are evaluated during the physical examination: (1) face at rest, (2) nose breathing, (3) facial expression, (4) masticatory muscle and jaw function, (5) oral motor function and (6) speech. For the evaluation of orofacial dysfunction during the clinical examination, the participants will be asked to perform tasks for each item in accordance with the illustrated manual. Each item has criteria for the respective function. A YES response or task the meets the criteria for compromised function will be scored 1 point, indicating dysfunction in the respective domain. A NO response or task that does not meet the criteria will be scored zero. The total is the sum of the points of all domains and ranges from 0 to 12, with higher scores denoting greater orofacial disfunction.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026