Evaluation of Intravascular Irradiation of Blood in Children With Sleep Bruxism

NCT05301452 | Unknown Phase 2

• 1 other identifier: ILIBSleepBruxism
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Changes in Oximetry

  A portable pulse oximeter that includes Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry under motion and low perfusion conditions will be used. Nocturnal oximetry will be performed prior to treatment and post treatment. The parents or guardians of the minor will be trained.

  Baseline and 8 weeks of treatment.

Secondary Outcomes (6)

• Changes in Breathing

  Baseline and 8 weeks of treatment.

• Changes in Swallowing

  Baseline and 8 weeks of treatment.

• Changes in Chewing

  Baseline and 8 weeks of treatment.

• Changes in Speech

  Baseline and 8 weeks of treatment.

• Changes in the Presence of Bruxism

  Baseline and 8 weeks of treatment.

Study Arms (2)

Control Group

PLACEBO COMPARATOR

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

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

ILIB Group

ACTIVE COMPARATOR

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

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

Interventions

Intravascular Irradiation of Blood (ILIB) RADIATION

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.

ILIB Group

Placebo Intravascular Irradiation of Blood (ILIB) RADIATION

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.

Control Group

Orofacial Myofunctional Therapy PROCEDURE

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).

Control Group; ILIB Group

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

Related Publications (1)

• Viarengo NO, Goncalves MLL, Bruno LH, Fossati AL, Sertaje MRF, Santos EM, Sobral APT, Mesquita-Ferrari RA, Fernandes KPS, Horliana ACRT, Motta LJ, Bussadori SK. Evaluation of intravascular irradiation of blood in children with sleep bruxism: Study protocol for a randomized controlled clinical trial. Medicine (Baltimore). 2022 Nov 4;101(44):e31230. doi: 10.1097/MD.0000000000031230.

  PMID: 36343030 DERIVED

MeSH Terms

Conditions

Sleep Bruxism

Interventions

Myofunctional Therapy

Condition Hierarchy (Ancestors)

Bruxism; Tooth Diseases; Stomatognathic Diseases; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Dentistry

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The participants will not know whether they belong to the placebo group, or the active photobiomodulation group, seeing as the laser application will be simulated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 16, 2022
• First Posted: March 29, 2022
• Study Start: October 1, 2022
• Primary Completion: June 20, 2023
• Study Completion: November 1, 2023
• Last Updated: August 9, 2022

Record last verified: 2022-08