Clinical trial NCT05301452: Evaluation of Intravascular Irradiation of Blood in Children With Sleep Bruxism
Official title: Evaluation of Intravascular Irradiation of Blood in Children With Sleep Bruxism - Study Protocol for a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Sleep Bruxism
Sleep Bruxism, Childhood
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 46
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in Oximetry
timeFrame: Baseline and 8 weeks of treatment.
Secondary outcomes:
measure: Changes in Breathing
timeFrame: Baseline and 8 weeks of treatment.
measure: Changes in Swallowing
timeFrame: Baseline and 8 weeks of treatment.
measure: Changes in Chewing
timeFrame: Baseline and 8 weeks of treatment.
measure: Changes in Speech
timeFrame: Baseline and 8 weeks of treatment.
measure: Changes in the Presence of Bruxism
timeFrame: Baseline and 8 weeks of treatment.
measure: Changes in Sleep Quality
timeFrame: Baseline and 8 weeks of treatment.
Other outcomes:
Locations:
Study officials:
References:
citation: 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.