Evaluation of Melatonin and Hyaluronic Acid in Maxillary Sinus Augmentation (a Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- change Implant stability
研究概览
简要总结
melatonin proved an ability to repair bone defects and enhance osseointegration of dental implants. Also, hyaluronic acid has osteopromoting properties.
the effect of melatonin and hyaluronic acid on the newly formed bone in maxillary sinus augmentation was evaluated
详细描述
16 participants with missing maxillary posterior teeth and residual alveolar ridge of at least 5 mm will be equally and randomly divided into two groups.
The study group will receive melatonin and hyaluronic acid after sinus membrane elevation and simultaneous implant placement while the control group will not receive any materials after sinus membrane elevation and simultaneous implant placement.
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, Investigator)
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range will be between (30 - 50) years old.
- •Patients with missed one or more of posterior teeth with minimum residual bone height 5 mm
- •Adequate inter-occlusal space of at least 8 mm
排除标准
- •Maxillary sinus diseases.
- •Previous sinus surgery like the Caldwell-Luc operation.
- •History of chemotherapy or radiotherapy to maxilla.
- •Presence of Underwood's septa/severe sinus floor convolutions.
- •Systemic disease affecting bone metabolism.
- •Uncontrolled diabetes mellitus.
- •Heavy smokers.
- •Para functional habits.
结局指标
主要结局
change Implant stability
时间窗: at baseline and 6 months
The result is presented as an ISQ value of 1-100. The acceptable stability range lies between 55-85 ISQ. The higher the ISQ, the more stable the implant
change in bone density
时间窗: at baseline, 1 month and 6 months
radiographical evaluation using CBCT
change in vertical bone height
时间窗: at baseline, 1 month and 6 months
radiographical evaluation using CBCT
change in marginal bone level
时间窗: at baseline, 1 month and 6 months
radiographical evaluation using CBCT
次要结局
- Postoperative pain(after 1 week)
- Postoperative swelling(after 1 week)
研究者
Hams Hamed Abdelrahman
Assistant lecturer of DPH and Clinical statistician
Alexandria University