Evaluation of Intravascular Irradiation of Blood in Children With Sleep Bruxism - Study Protocol for a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 46
- 主要终点
- Changes in Oximetry
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •in the mixed dentition phase (permanent incisors and first molars erupted);
- •adolescents with an established permanent dentition.
排除标准
- •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.
结局指标
主要结局
Changes in Oximetry
时间窗: Baseline and 8 weeks of treatment.
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.
次要结局
- Changes in Chewing(Baseline and 8 weeks of treatment.)
- Changes in Breathing(Baseline and 8 weeks of treatment.)
- Changes in Speech(Baseline and 8 weeks of treatment.)
- Changes in Swallowing(Baseline and 8 weeks of treatment.)
- Changes in the Presence of Bruxism(Baseline and 8 weeks of treatment.)
- Changes in Sleep Quality(Baseline and 8 weeks of treatment.)
研究者
Sandra Kalil Bussadori
Principal Investigator
University of Nove de Julho