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Evaluation of Intravascular Irradiation of Blood in Children With Sleep Bruxism

NCT05301452 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2022-08-09

No results posted yet for this study

Summary

Background: The objective of this study will be to evaluate the effect of Intravascular Irradiation of Blood (ILIB) combined with myofunctional exercises for sleep bruxism in pediatrics. Methods: This study will be a randomized controlled clinical trial. A triage of individuals between 4 and 17 years old with a diagnosis of sleep bruxism will be carried out at the clinic of the Catholic University of Uruguay, and in a private office referred by different private care centers. The selected participants will be evaluated before and after treatment by means of questionnaires on bruxism, sleep quality and nocturnal oxygen saturation measurement. For this, 46 patients with sleep bruxism will be recruited, who will be divided into 2 groups: control group (CG), which will undergo an application of placebo ILIB and an orofacial myofunctional therapy (MFT) exercise protocol; and na ILIB group, which will carry out an active application of ILIB and an exercise protocol, this being once a week for 8 weeks. The laser treatment (808 nm) will be performed twice a week for 8 weeks. The values will be tested for normality by the Kolmogorov-Smirnov test. For the comparison between the groups, T-test will be carried out, considering a level of significance of 0.5% (p\<0.05). Discussion: Although local photobiomodulation (PBM), acupuncture PBM and physiotherapy have been studied in the treatment of bruxism, this is the first study to evaluate the effect of ILIB combined with myofunctional exercises for sleep bruxism in pediatrics.

Conditions

  • Sleep Bruxism
  • Sleep Bruxism, Childhood

Interventions

RADIATION

Intravascular Irradiation of Blood (ILIB)

The laser treatment will be performed by a speech therapist and will have the following parameters: wavelength of 808 nm. It will be done twice a week for 8 weeks, in 20-minute sessions.

RADIATION

Placebo Intravascular Irradiation of Blood (ILIB)

The photobiomodulation procedure will be simulated, but with the laser turned off. It will be done twice a week for 8 weeks, in 20-minute sessions.

PROCEDURE

Orofacial Myofunctional Therapy

Myofunctional therapy will be performed by a speech therapist specialized in the area. It will consist of 1 weekly session, where the functions of breathing, chewing and swallowing will be evaluated and addressed. The following exercises will be indicated: nasal hygiene, inflated cheeks with the tip of the tongue on the palate, lingual sweep, tongue thrust against the palate, tongue touch on the last molars, chewing of soft solids and bolus assembly (20 minute therapy session).

Sponsors & Collaborators

  • University of Nove de Julho

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2023-06-20
Completion
2023-11-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05301452 on ClinicalTrials.gov