Clinical trial NCT04211870: Effects of Photobiomodulation in Children With Down Syndrome and Possible Sleep Bruxism
Official title: Effects of Photobiomodulation in Children With Down Syndrome and Possible Sleep Bruxism: Protocol For A Randomized, Controlled, Blind, Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Sleep Bruxism
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2019-12-26
Enrollment: 19
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of electromyography of masticatory muscles
timeFrame: Baseline and immediately after each the procedure.
Secondary outcomes:
measure: Orofacial Evaluation Through NOT-S (score from 0 to 12)
timeFrame: Baseline and immediately after each the procedure.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Nove de Julho University
Study officials:
References:
citation: 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.