Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05301452
Study type Interventional
Source University of Nove de Julho
Contact
Status Not yet recruiting
Phase Phase 2
Start date October 1, 2022
Completion date November 1, 2023

See also
  Status Clinical Trial Phase
Terminated NCT03522207 - Accuracy and Efficacy of Trazodone (Desyrel) on Sleep Quality and Pain Management of TMD Patient Phase 4
Completed NCT02340663 - Nocturnal Mouth Guards, SOVA vs. Standard Acrylic Orthotic; Phase IV N/A
Recruiting NCT06153810 - Efficacy of AesyBite Active in Reducing Sleep Bruxism Activity N/A
Completed NCT03325920 - Validation of a Diagnostic Method for Quantification of Sleep Bruxism N/A
Not yet recruiting NCT05784454 - Prevalance of Sleep Bruxism Among a Group of Egyptian Children
Completed NCT02410681 - Sleep Bruxism and (Peri-)Implant Complications
Recruiting NCT01336439 - Effects of Botulinum Toxin Type A(Meditoxin®) on Sleep Bruxism Phase 4
Completed NCT01255878 - Comparative Evaluation of Gabapentine and Occlusal Splint in the Management of Sleep Bruxism N/A
Not yet recruiting NCT04211870 - Effects of Photobiomodulation in Children With Down Syndrome and Possible Sleep Bruxism Phase 1/Phase 2
Not yet recruiting NCT02757261 - Evaluation of Muscle Activity, Bite Force and Salivary Cortisol in Children With Bruxism Phase 0
Enrolling by invitation NCT04937036 - Impact of Bruxism Related Arousals on Cardiovascular Risk in Co-morbid Insomnia and Sleep Apnea
Completed NCT02882880 - Treatment Sleep Bruxism With the Luco Hybrid OSA Appliance N/A
Withdrawn NCT04078074 - Occlusal Stabilization Splints and Sleep Disordered Breathing N/A
Completed NCT01178229 - Physiotherapy on the Airway of Bruxist Children Phase 1/Phase 2
Completed NCT03766477 - Aspects Associated With Sleep Quality
Recruiting NCT06343194 - Changes in Electromyographic Activity in Aligner Treatment of Adult Patients With and Without Nocturnal Bruxism N/A
Completed NCT03039985 - All-ceramic Crowns in Patients With Sleep Bruxism N/A
Enrolling by invitation NCT04214561 - Relationship Between Selected Parameters and Bruxism
Recruiting NCT06214637 - Effectiveness of Melissa Officinalis for the Treatment of Probable Sleep Bruxism in Children and Adolescents Phase 1
Enrolling by invitation NCT03083405 - Selected Disorders and Sleep Bruxism