NCT05283928已完成不适用
Implant Primary Stability and Ridge Dimensional Changes Utilizing the Osseodensification Protocol
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in Bone Ridge Width at Crest
研究概览
简要总结
The purpose of this study is to compare ridge dimensional changes between densification and standard drilling protocols and to compare primary and secondary stability of implants placed by bone densification and standard drilling protocols
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
- None
入排标准
- 年龄范围
- 22 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who understand and agree to this study.
- •Adequate Oral hygiene
- •One or more edentulous spaces, which are 10 weeks or longer after extractions
排除标准
- •Pregnancy.
- •Smoking of more than 5 cigarettes/day.
- •History of alcoholism or drug abuse during the last 5 years.
- •Uncontrolled Hypertension or diabetes.
- •Patient with malignant tumor.
- •Patients on daily dose of steroids.
- •Patients with history of chemotherapy or radiation for the last 12 months.
结局指标
主要结局
Change in Bone Ridge Width at Crest
时间窗: day of implant surgery
bone ridge width will be measured using a Caliper
Change in Bone Ridge Width at 5mm Apical From Crest
时间窗: day of implant surgery
bone ridge width will be measured using a Caliper
Change in Bone Ridge Width at 10mm Apical From Crest
时间窗: day of implant surgery
bone ridge width will be measured using a Caliper
次要结局
- Primary Stability of the Implants as Measured by the Insertion Torque Values(day of implant surgery)
- Primary Stability of the Implants as Indicated by the Implant Stability Quotient (ISQ) as Measured by the Resonance Frequency Analysis Using the Ostell ISQ Meter Baseline(After Implant Placement)(baseline(after implant placement))
- Primary Stability of the Implants as Indicated by the Implant Stability Quotient (ISQ) as Measured by the Resonance Frequency Analysis Using the Ostell ISQ Meter 3 Weeks After Implant Placement(3 weeks after implant placement)
- Primary Stability of the Implants as Indicated by the Implant Stability Quotient (ISQ) as Measured by the Resonance Frequency Analysis Using the Ostell ISQ Meter 6 Weeks After Implant Placement(6 weeks after implant placement)
- Primary Stability of the Implants as Indicated by the Implant Stability Quotient (ISQ) as Measured by the Resonance Frequency Analysis Using the Ostell ISQ Meter 12 Weeks After Implant Placement(12 weeks after implant placement)
- Volume of the Ridge as Assessed by the Cone Beam Computer Tomography (CBCT)(6 months post implantation)
- Percent Change of Buccal Bone Thickness as Assessed by the Cone Beam Computer Tomography at 1.5 mm From the Implant Platform(6 months post implantation)
- Percent Change of Buccal Bone Thickness as Assessed by the Cone Beam Computer Tomography at 5 mm From the Implant Platform(6 months post implantation)
研究者
Popi Stylianou
Clinical Associate Professor
The University of Texas Health Science Center, Houston
研究点 (2)
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