Evaluation of intravascular irradiation of blood in children with sleep bruxism: Study protocol for a randomized controlled clinical trial

Natalia Osorio Viarengo, Marcela Leticia Leal Gonçalves, Laura Hermida Bruno, Ana Laura Fossati, María Roxana Ferreira Sertaje, Elaine Marcilio Santos, Ana Paula Taboada Sobral, Raquel Agnelli Mesquita-Ferrari, Kristianne Porta Santos Fernandes, Anna Carolina Ratto Tempestini Horliana, Lara Jansiski Motta, Sandra Kalil Bussadori, Natalia Osorio Viarengo, Marcela Leticia Leal Gonçalves, Laura Hermida Bruno, Ana Laura Fossati, María Roxana Ferreira Sertaje, Elaine Marcilio Santos, Ana Paula Taboada Sobral, Raquel Agnelli Mesquita-Ferrari, Kristianne Porta Santos Fernandes, Anna Carolina Ratto Tempestini Horliana, Lara Jansiski Motta, Sandra Kalil Bussadori

Abstract

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 < .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.

Trial registration: ClinicalTrials.gov NCT05301452.

Conflict of interest statement

The authors have no conflicts of interest to disclose.

Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc.

Figures

Figure 1.
Figure 1.
SPIRIT figure as recommended by 2013 SPIRIT statement. SPIRIT = standard protocol items: recommendations for interventional trials.
Figure 2.
Figure 2.
Sample size calculation. Analysis: A priori: Compute required sample size; Input: Tail(s) = One; Effect size dz = 0.5373031; α err prob = 0.05; Power (1-β err prob) = 0.8; Output: Noncentrality parameter δ = 2.576815; Critical t = 1.7171444; Df = 22; Total sample size = 23; Actual power = 0.8027361.[19]

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