The Effect of Vitamin D and Calcium Supplement on Overall Body Bone Density and Implant Stability in Posterior Maxilla: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- The Implant Stability Quotient
研究概览
简要总结
The aim of the study is to evaluate the effect of Vit D and Calcium administration on allogragt bone maturation radiographically and histomorphometercally in maxillary sinus augmentation in cases of D4 bone density.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient with residual bone height from 5 : 8 .
- •Patient with insufficient Vit D levels.
- •Patient with D4 bone density.
排除标准
- •Patients that have aproporiate amount of Ca and Vit D.
- •Sinus pathology that precludes routine sinus augmentation.
- •Heavy smookers patients.
- •Systemic diseases that interfere with bone maturion.
研究组 & 干预措施
Group A : Patients received vitamin D and calcium supplementation during the healing period
- Monthly intramuscular injections of vitamin D3 (300,000 I.U.) for three months, concurrent with six months of oral Maxical vitamin D supplementation post-implant placement.
- Daily intake of Maxical calcium carbonate tablets (600 mg elemental calcium) for six months.
干预措施: Patients received vitamin D and calcium supplementation during the healing period (Procedure)
Group B: Patients have not received any nutritional supplementation during the healing period.
干预措施: Patients have not received any nutritional supplementation during the healing period. (Procedure)
结局指标
主要结局
The Implant Stability Quotient
时间窗: Immediate post-operative, and 6 Months post-operative
The Implant Stability Quotient (ISQ) will be assessed using the Osstell device, which provides a stability score ranging from 0 ISQ to 100 ISQ. Higher ISQ values indicate greater implant stability, with 0 ISQ representing the lowest stability and 100 ISQ the highest. This measure allows for consistent, objective assessment of implant stability across time points.
次要结局
- DXA Scan(pre-operative, and 6 Months post-operative)
- Vitamin D serum levels(Pre-operative, and 6 Months post-operative)
- Calcium Serum Level(Pre-operative, and 6 Months post-operative)
研究者
Mostafa Sharkawy
Resident at Oral and Maxillofacial Surgery
Al-Azhar University