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

NCT ID: NCT04211870

Last Updated: 2024-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-20
• Study Completion Date: 2024-07-20

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group Intervention

Treatment with LED clusters.

Group Type: EXPERIMENTAL

LED clusters

Intervention Type: 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.

Interventions

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.

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Sandra Kalil Bussadori

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Nove de Julho University

São Paulo, , Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 32332670 (View on PubMed)

Other Identifiers

DownSyndrome

Identifier Type: -

Identifier Source: org_study_id