Effect of the Intervention "Food, Fun and Family" on Sleep Bruxism in Children
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 主要终点
- Frecuency of sleep bruxism
研究概览
简要总结
Excess consumption of refined sugar and increased use of recreational screen time are risk factors for alterations in the quality of life that have been associated with sleep bruxism in children and that compromise the same mechanisms of alteration of the reward system in the brain. Therefore, the question of this research is: What is the effect of the Intervention "Food, Fun and Family (FFF)" on the frequency of sleep bruxism in children? The general objective of the research is to evaluate the effect of the Intervention "Food, Fun and Family (FFF)" on the frequency of sleep bruxism in 84 children who attend the pediatric dentistry postgraduate clinic of the CES University and the private consultation Dr. Claudia Restrepo and Dr. Adriana Santamaría. The frequency of sleep bruxism will be evaluated with the translated and validated Spanish version of the Children's Sleep Habits Questionnaire (CSHQ), which will be answered by the parents. The consumption of added sugar will be evaluated with the version translated into Spanish of the Health Behavior in School-Aged Children - Food-Frequency Questionnaire (HBSC-FFQ). The time on screens will be recorded through the parents' report, of the time in hours that the child spends using electronic media in a recreational way each weekday for a week and each weekend day for a week.
A decrease in the frequency of sleep bruxism is expected to be found by reducing sugar consumption and screen time in the children evaluated.
The results of this study will be presented at the IADR, ACFO, ACOP and CES University research meetings and will be published in a peer-reviewed scientific journal in category Q1.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children who eat breakfast, lunch and dinner at home.
- •Children whose feeding and habits management (upbringing) is in charge of the same group of representative adults.
- •Children who live with their parents.
- •Children attending the consultation for the first time.
排除标准
- •Symptoms of respiratory disorders reported by parents in the CSHQ.
- •Food allergies.
- •Special diet restrictions.
- •Developmental disorder influencing diet or weight.
- •Basic endocrinological diseases.
- •Being under endocrinological treatment.
- •Previously diagnosed sleep disorders.
- •Children who miss more than two assigned appointments.
- •Parents of children who withdraw informed consent.
- •Children who are diagnosed during the study with respiratory disorders.
- •Children who are diagnosed during the study with food allergies.
- •Children who for personal reasons cannot continue in the study.
结局指标
主要结局
Frecuency of sleep bruxism
时间窗: 8 weeks
Report from the parents in the CSHQ with values of usually, some times and no/rarely
次要结局
- Frecuency of added sugar consumption(8 weeks)
- Screen time(8 weeks)
研究者
Claudia Cecilia Restrepo Serna
CES-LPH research group director
CES University