NCT05301452

Evaluation of Intravascular Irradiation of Blood in Children With Sleep Bruxism

Evaluation of Intravascular Irradiation of Blood in Children With Sleep Bruxism - Study Protocol for a Randomized Controlled Clinical Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: University of Nove de Julho · Academic / Other
• Sex: All
• Age: 4 Years – 17 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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).

Timeline

• Start date: 2022-10-01
• Primary completion: 2023-06-20
• Completion: 2023-11-01
• First posted: 2022-03-29
• Last updated: 2022-08-09