Evaluation of Muscle Activity, Bite Force and Salivary Cortisol in Children With Bruxism Before and After Laser Use of Low Power in Acupoints- Controlled Clinical Trial
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 76
- 主要终点
- Change in ELECTROMYOGRAPHIC EVALUATION OF MASTICATORY AND TRAPEZIUS MUSCLES
研究概览
简要总结
Bruxism is a repetitive activity of the masticatory muscles characterized by grinding and/or clenching one's teeth or parafunctional movements of the mandible. The aim of the proposed controlled clinical trial is to evaluate muscle activity, bite force and salivary cortisol in children aged six to eight years with bruxism. The children will be randomly allocated to four groups, each with 19 participants: Group 1 will receive low-level laser therapy at acupuncture points; Group 2 will use an occlusal splint; Group 3 will receive placebo laser therapy; and Group 4 will be the control group without bruxism. Low-level laser (786.94 nm, 0.04 cm2, 70 mW and 20 s per points) will be applied directly on the skin at six acupuncture points on each side. The BTS TMJOINT electromyograph will be used to determine muscle activity and a digital gnathodynamometer will be used to measure bite force. Two saliva collections will be performed in the participant's home at 9 am and prior to going to sleep, with at least one hour of fasting and followed by oral hygiene with water. Evaluations will be performed before as well as one and six months after treatment. The findings will be computed and submitted to statistical analysis. Descriptive statistics will be used first for the determination of point estimates, precision and validation using analysis of variance (ANOVA) for the evaluation of residuals and parametric tests will be used for the determination of pre-treatment conditions. Interval estimates will be used for the variables of interest to determine the prevision of the estimates and perform comparisons. When necessary, transformation methods or non-parametric tests will be used in the data analysis. The chi-square test, Student's t-test and ANOVA will be employed, with the level of significance set at 5% (p < 0.05).
详细描述
The aim of the proposed study is to evaluate the electromyographic activity of the masseter, anterior temporal and trapezius muscles as well as bite force, occlusal contacts and salivary cortisol following the administration of low-level laser therapy at acupoints or occlusal splint usage in children with sleep bruxism.
A randomized, controlled, clinical trial is proposed, which will be conducted in compliance with the norms governing research involving human subjects, following approval from the Institutional Review Board of University Nove de Julho (Brazil) under process number 1.333.636. The participants and/or legal guardians will receive clarifications regarding the objectives and procedures and will sign a statement of informed consent.
Individuals making use of muscle relaxants, those with temporomandibular disorder and those currently undergoing another treatment for bruxism will be excluded from the study.
Male and female children aged six to eight years with no physical or psychiatric limitations that may compromise the proposed therapies will be included. All individuals will need to have the first molars in Angle Class I and be free of dental caries. A clinical examination of tooth wear and the reports of parents/caregivers regarding tooth clenching/grinding will be used for the diagnosis of bruxism, following the criteria established by the American Academy of Sleep Medicine1 and the use of a questionnaire adapted by Serra Negra (2014).
The participants will be randomly allocated to four groups. Evaluations will be performed before and after treatment. Muscle activity will be determined using the BTS TMJOINT® device; bite force will be determined using a gnathodynamometer and salivary cortisol will be measured.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 6 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female children
- •Aged six to eight years
- •No physical or psychiatric limitations
- •Need to have the first molars in Angle Class I
- •Free of dental caries
- •A clinical examination of tooth wear and the reports of parents/caregivers regarding tooth clenching/grinding will be used for the diagnosis of bruxism, following the criteria established by the American Academy of Sleep Medicine1 and the use of a questionnaire adapted by Serra Negra (2014).
排除标准
- •Use of muscle relaxants
- •Temporomandibular disorder
- •Currently undergoing another treatment
结局指标
主要结局
Change in ELECTROMYOGRAPHIC EVALUATION OF MASTICATORY AND TRAPEZIUS MUSCLES
时间窗: Before and after treatment and follow up 1 month and 6 months
six-channel BTS TMJOINT electromyograph (BTS Engineering)
Change in Bite force
时间窗: Before and after treatment and follow up 1 month and 6 months
Bite force will be measured using a digital gnathodynamometer (DMD, Kratos Equipamentos Industriais Ltda, Cotia, São Paulo, Brazil) adapted for oral conditions
Change in Salivary cortisol
时间窗: Before and after treatment and follow up 1 month and 6 months
Saliva will be collected on cotton swabs, which will be left in the mouth for two minutes. The cotton will then be placed into a centrifuge tube and the sample will be stored at -20° C until analysis.25 Salivary cortisol will be measured prior to therapy and on Day 50 to measure the degree of stress. Two collections will be performed in the home of the participant at 9 am and prior to going to sleep with at least one hour of fasting prior to the collection and will be followed with oral hygiene with water. The collection will be performed on a Sunday following the manufacturer's recommendations and will be delivered on the following Monday for analysis at University Nove de Julho (Brazil).
次要结局
未报告次要终点
研究者
Monica Canuto Salgueiro
Monica Canuto Salgueiro
University of Nove de Julho