Restoration of Immediate Peri-implant Defect by Simvastatin: a Controlled Clinical and Cone Beam Computed Tomography Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- Effect of simvastatin on gap fill
研究概览
简要总结
The study evaluated the effect of local application of simvastatin around immediate implant on the amount of gap fill, ridge dimensional alterations and bone density in humans.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients between 20 and 50 years old
- •requiring the extraction of 2 non-restorable maxillary canine or premolar on each side of the arch
- •following extraction, the crestal bone had to be located 3 mm apical to the free gingival margin
- •at least 3 mm of bone beyond the root apex was required to guarantee implant primary stability
排除标准
- •unstable systemic diseases precluding surgical procedures
- •compromised general health conditions that would impair bone healing including present history of bone irradiation, patient on bisphosphonates therapy, antitumor chemotherapy
- •pregnancy
- •compromised healing conditions e.g. uncontrolled diabetes mellitus
研究组 & 干预措施
Control group
the solid lipid nanoparticles carrier was injected into the jumping distance.
干预措施: Placebo (Drug)
Simvastatin group
simvastatin gel (1.2 mg/0.1 ml of solid lipid nanoparticles) was locally applied to fill the jumping distance.
干预措施: Simvastatin (Drug)
结局指标
主要结局
Effect of simvastatin on gap fill
时间窗: 3 months after implant placement
using cone beam computed tomography
Effect of simvastatin on horizontal ridge dimension
时间窗: 3 months after implant placement
using cone beam computed tomography
Effect of simvastatin on crestal bone level
时间窗: 3 months after implant placement
using cone beam computed tomography
Effect of simvastatin on bone density
时间窗: 3 months after implant placement
using cone beam computed tomography
次要结局
- Quality of wound healing(2 weeks after implant placement)
研究者
Mina Adel Rizk Botros
Assistant Researcher
Ain Shams University