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

NCT04211870 | Completed Phase 1

• 1 other identifier: DownSyndrome
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Bruxism

Outcome Measures

Primary Outcomes (1)

• Evaluation of electromyography of masticatory muscles

  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.

  Baseline and immediately after each the procedure.

Secondary Outcomes (1)

• Orofacial Evaluation Through NOT-S (score from 0 to 12)

  Baseline and immediately after each the procedure.

Study Arms (1)

Group Intervention

EXPERIMENTAL

Treatment with LED clusters.

Radiation: LED clusters

Interventions

LED clusters RADIATION

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.

Group Intervention

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Nove de Julho University

São Paulo, 01525-000, Brazil

Location

Related Publications (1)

• Salgueiro MDCC, Silva T, Motta LJ, Horliana ACRT, Goncalves MLL, Gomes AO, Pinto MM, Bortoletto CC, Altavista OM, Deana AM, Silva DFTD, Santos EM, Castelo PM, Fernandes KPS, Mesquita-Ferrari RA, Bussadori SK. Effects of Photobiomodulation in Children with Down Syndrome and Possible Sleep Bruxism: Protocol For A Randomized, Controlled, Blind, Clinical Trial: Study protocol clinical trial (SPIRIT compliant). Medicine (Baltimore). 2020 Apr;99(17):e19904. doi: 10.1097/MD.0000000000019904.

  PMID: 32332670 DERIVED

MeSH Terms

Conditions

Sleep Bruxism

Condition Hierarchy (Ancestors)

Bruxism; Tooth Diseases; Stomatognathic Diseases; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: December 26, 2019
• Study Start: March 20, 2022
• Primary Completion: November 20, 2023
• Study Completion: July 20, 2024
• Last Updated: November 19, 2024

Record last verified: 2024-11

Locations

BR (1)