Systemic Vitamin D Supplementation in Menopausal Women With Dental Implants
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 试验地点
- 3
- 主要终点
- 25 OH Serum levels
研究概览
简要总结
Vitamin D plays an essential role in calcium homeostasis and is critical for bone formation and remodeling.
详细描述
Evidence has demonstrated that vitamin D deficiency plays an important role in dental implants outcomes.
Low serum levels of Vitamin D is considered as a risk factor, not only for low mineral bone density but also in other metabolic pathways such as those involved in immune response and chronic inflammatory diseases.
There are few studies demonstrating the role that vitamin D deficiency in the etiopathogenesis of oral diseases and the consequences in Dental Implants.
Dentists have not yet well understood the importance of a good bone metabolism response for a successful bone regeneration and osseointegration of implants.
An insufficient bone response can not guarantee the necessary stability of the implants placed in it, has been one of the biggest problems of implantology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 5 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Menopause patients
排除标准
- •patients with a past history of neurological disorder;
- •who had received pharmacotherapy for depression within 8 weeks of screening;
- •who were taking medication known to interfere with Vit D;
- •who had recent psychiatricor systemic illness;
- •uncontrolled hypertension (blood pressure > 160/95mmHg);
- •unstable cardiovascular disease;
- •User of psychoactive medications;
- •alcohol excess consumption abuse.
研究组 & 干预措施
Vit D
Vit D 20 mg/day
干预措施: Vit D (Drug)
结局指标
主要结局
25 OH Serum levels
时间窗: 2 years
VIT D Serum levels
次要结局
- Osteoporosis condition(2 years)
研究者
MARCO BOTELHO
Program Director of Graduate Biotechnology
University Potiguar