Efficacy of Perioperative Oral Vitamin D3 Supplementation on Implant Osseointegration in Patients With Vitamin D Deficiency
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The stability of the implan
研究概览
简要总结
The number of patients treated in Implantology at Nantes University Hospital is 400 per year. This pilot study aims to demonstrate the efficacy of a 6-month oral cholecalciferol supplementation on osseointegration in patients requiring dental implants and presenting with vitamin D deficiency, compared to French patients who have not undergone vitamin D screening
详细描述
This study will be conducted on patients with vitamin D deficiency or insufficiency who visit the Restorative and Surgical Dentistry Department at the Dental Care Center of Nantes University Hospital for implant surgery. The investigator will present the study to them and record their verbal non-opposition. Clinical data from before the surgery (approximately 3 months prior), during the surgery, and postoperative visits up to 3 months afterward will be included in the OSIVID study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient ≥ 18 years old, candidate for dental implant placement.
- •with vitamin D deficiency or insufficiency: 25(OH)D < 25 ng/L.
- •affiliated with a social security scheme.
排除标准
- •with a local contraindication for implant placement.
- •under guardianship, curatorship, or legal protection
- •Pregnant or breastfeeding women
研究组 & 干预措施
patient with supplementation of vitamin D3
perioperative oral vitamin D3 supplementation on implant osseointegration in patients with vitamin D deficiency.
结局指标
主要结局
The stability of the implan
时间窗: 3 months (surgery and 3 months after)
The stability of the implant measured by RFA (Resonance Frequency Analysis)
次要结局
未报告次要终点