Effectiveness of Melissa Officinalis in Various Concentrations for the Treatment of Probable Sleep Bruxism in Children and Adolescents: Controlled and Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- General objective
研究概览
简要总结
Objective: To investigate, through a controlled and randomized clinical trial, the effectiveness of using Melissa officinalis in different concentrations in the treatment of children and adolescents with probable sleep bruxism. Methodology: This is a randomized, triple-blind, crossover, and placebo-controlled clinical trial. The research participants will be children aged 5 to 10 years old and adolescents aged 11 to 16 years old who attend dental treatment at the FO/UFRJ Pediatric Dentistry Clinics. After approval by the Human Research Ethics Committee, children and adolescents will undergo homeopathic treatment with Melissa officinalis in different concentrations for possible sleep bruxism. In addition, research participants will undergo an assessment of TMJ, sleep, circadian cycle, quality of life, and quality of life related to oral health. The data will be tabulated and analyzed according to sex, age group, presence of possible sleep bruxism, presence or absence of TMD, circadian characteristics, presence or absence of sleep disorders, daytime and nighttime behavioral characteristics. The data will be tabulated and evaluated using SPSS 21.0. Absolute and relative frequency, odds ratio, correlation analysis and other relevant analyzes and statistical tests (p<0.05) will be carried out in accordance with the objectives proposed by the study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 5 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 5 to 16 years;
- •Patients with complete primary dentition, mixed or secondary dentition;
- •Patients with probable sleep bruxism.
排除标准
- •Patients with special needs (psychological, psychiatric and neurological, diagnosed with anxiety disorder or any systemic impairment);
- •Patients with parafunctional habits (finger sucking and/or pacifier, onychophagia, biting objects, etc.)
- •Patients with caries lesions in dentin in one or more elements (ICDAS values 4, 5 and 6);
- •Patients affected by molar-incisor hypomineralization (MIH)
- •Patients with dental anomalies such as dentinogenesis imperfecta, amelogenesis imperfecta, dysplasia dentin, hypoplasia, and enamel hypocalcification;
- •Patients with severe malocclusions: Class II and III or crossbite and open bite type;
- •Patients using orthodontic appliances;
- •Patients who are taking medications for anxiety disorders or any other that cause alterations in the central nervous system or that alter salivary flow.
研究组 & 干预措施
Placebo
It will be administered for a period of 30 days, once a day before bed, with a 15-day wash-out interval. The placebo, a drug without active substance, that will be administered to research participants will be the biotherapeutic vehicle, that is, 30% alcohol (v/v), which is commonly used as a vehicle for homeopathic medicines.
干预措施: Placebo (Drug)
Melissa officinalis 6 CH
It will be administered for a period of 30 days, once a day before bed, with a 15-day wash-out interval. This concentration that will be administered to research participants will be the biotherapeutic vehicle, that is, 30% alcohol (v/v), which is commonly used as a vehicle for homeopathic medicines.
干预措施: Melissa (Drug)
Melissa officinalis 9 CH
It will be administered for a period of 30 days, once a day before bed, with a 15-day wash-out interval. This concentration that will be administered to research participants will be the biotherapeutic vehicle, that is, 30% alcohol (v/v), which is commonly used as a vehicle for homeopathic medicines.
干预措施: Melissa (Drug)
Melissa officinalis 12 CH
It will be administered for a period of 30 days, once a day before bed, with a 15-day wash-out interval. This concentration that will be administered to research participants will be the biotherapeutic vehicle, that is, 30% alcohol (v/v), which is commonly used as a vehicle for homeopathic medicines.
干预措施: Melissa (Drug)
结局指标
主要结局
General objective
时间窗: Twice a month
Number of participants who had a positive response to the proposed treatment, that is a reduction in bruxism episodes during the sleep period.
次要结局
未报告次要终点
研究者
Larissa Soares Lima da Silva
Principal Investigator
Universidade Federal do Rio de Janeiro