NCT04211870

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: University of Nove de Julho · Academic / Other
• Sex: All
• Age: 4 Years – 17 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
RADIATION	LED 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.

Timeline

• Start date: 2022-03-20
• Primary completion: 2023-11-20
• Completion: 2024-07-20
• First posted: 2019-12-26
• Last updated: 2024-11-19

Locations

1 site across 1 country: Brazil