Evaluation of Intravascular Irradiation of Blood in Children With Sleep Bruxism

University of Nove de Julho

Status and phase: Not yet enrolling; Phase 2

Conditions: Sleep Bruxism; Sleep Bruxism, Childhood

Treatments: Procedure: Orofacial Myofunctional Therapy; Radiation: Placebo Intravascular Irradiation of Blood (ILIB); Radiation: Intravascular Irradiation of Blood (ILIB)

Study type: Interventional

Funder types: Other

Identifiers

NCT05301452

ILIBSleepBruxism

Details and patient eligibility

About

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.

Enrollment: 46 estimated patients

Sex: All

Ages: 4 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• in the mixed dentition phase (permanent incisors and first molars erupted);
• adolescents with an established permanent dentition.

Exclusion criteria

• People with dental caries;
• Those taking medications, such as inflammatory agents, muscle relaxants, corticosteroids, anticonvulsants, and antidepressants;
• Those with chronic diseases that affect muscles or motor coordination, and those who do not cooperate during the evaluation will be excluded from the study;
• Children with cerebral palsy;
• Patients whose guardians do not sign the informed consent or the user does not sign the assent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

46 participants in 2 patient groups, including a placebo group

Control Group

Placebo Comparator group

Description:

This group will receive an application of placebo ILIB and an orofacial myofunctional therapy (MFT) exercise protocol.

Treatment:

Procedure: Orofacial Myofunctional Therapy

Radiation: Placebo Intravascular Irradiation of Blood (ILIB)

ILIB Group

Active Comparator group

Description:

This group will receive an application of ILIB and an orofacial myofunctional therapy (MFT) exercise protocol.

Treatment:

Procedure: Orofacial Myofunctional Therapy

Radiation: Intravascular Irradiation of Blood (ILIB)