Prospective Study Comparing Standard Extraction Drilling With Osseodensification for Dental Implant Placement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Implant Primary Stability
研究概览
简要总结
The purpose of this study is to examine how Osseodensification, a well-defined bone preparation procedure utilizing special densifying burs (a tool to prepare bone) compares to the standard drilling procedure utilizing regular bone drills, to possibly enhance dental implant healing.
详细描述
Our postulated null hypotheses is that implants placed with osseodensification surgical drilling compared to those placed with subtractive conventional drilling technique in a split-mouth design will result: 1) in the same insertion torque values and; 2) in the same implant stability quotient values when measured immediately after implant placement and after 1, 2, 3, 4, 5, 6, 7, 8, and 12 weeks.
Study Objectives:
A.Perform a prospective clinical study to investigate implant primary stability through measuring insertion torque values (IT) and Implant stability quotient (ISQ) when implants are placed using a standard drilling protocol (subtractive surgical drilling, as recommended by implant manufacturers) compared to osseodensification drilling protocol in a split-mouth design.
B.Implant stability quotient will be measured once the implant is placed (immediate), and at 1, 2, 3, 4, 5, 6, 7, 8, and 12 weeks.
C.To investigate, and analyze these two surgical drilling protocols as function of different implant manufacturers with variations in diameter and length.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 22 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient needs an implant placements in both maxilla and mandible.
- •Patients are medically stable.
排除标准
- •Drug Abuse
- •Patient should not have been in any other research study in the last 90 days from the study starting date.
结局指标
主要结局
Implant Primary Stability
时间窗: Day 0
Implant primary stability is a mechanical parameters that reflects implant stability Day of surgery. Implant primary stability is measured by measuring implant insertion torque (measured during implant insertion with a torque wrench)
Implant Secondary Stability
时间窗: 1-16 weeks
During the weekly follow-up visits over 1-12 weeks, we will conduct a non-invasive measurement of implant secondary stability (correlated to BIC) utilizing the Osstell device. Osstell is a resonance frequency tester, which will create a gentle vibration in the implant and measure how much if any the implant moves with the vibration. The device will not loosen the implant. We will measure weekly. The standard of care is measurement of implant stability at 6-12 weeks post implant placement with yearly follow up as needed.
次要结局
- Cumulative implant survival rate(10-16 weeks)
- Bone Instrumentation effect on different implant geometry(1-16 weeks)
研究者
Salah Huwais
Principal Investigator
Jackson Implant Surgery