A Randomised Control Clinical Trial Investigating the Effect of Osseodensification on Implant Stability and Marginal Bone Levels
试验速览
- 阶段
- 不适用
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Implant Stability
研究概览
简要总结
Osseointegration refers to the formation of a structural and functional bone-to-implant interface, without the interposition of soft tissue. Successful osseointegration will provide long term success for the dental implant. Primary implant stability, is the mechanical stability between bone and the implant at the time of insertion and is key to initiate a successful osseointegration.
Both primary implant stability and osseointegration are affected by the density of the bone where the implant is placed. A relatively new technique known as osseodensification (OD) has been developed and uses specially designed burs (Densah burs). Compared to conventional drills (CD) that remove bone (subtractive drilling) these burs are designed so that they can rotate in a counterclockwise (CCW) (non subtractive) direction which allows bone to be preserved and compacted into the wall of the osteotomy site. These drills therefore theoretically maintain bone volume which then creates higher bone density and bone to implant contact allowing better implant primary stability.
This study will be a randomised control trial comparing OD to CD with regards to implant stability and bone levels. Considering the increased cost of OD, available literature must support a significant clinical benefit of OD over CD to consider them for clinical use. This study will aim to reinforce available clinical research and address some of the limitations of the current evidence to aid clinicians in making an evidenced-based decision on the use of OD when poor bone density could compromise implant success.
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
- Single (Participant)
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 Level
- •Male or Female, 18 years old or over
- •Capacity to provide informed consent
- •Willing to comply with study appointment schedule Willing to maintain a diary of symptoms
- •Planned for provision of dental implant(s) at Dublin Dental University Hospital
- •Location: maxilla
- •Sufficient bone volume for implant placement without the need for bone graft/augmentation; alveolar ridge of minimum 6mm width for standard implants (implant diameter 4mm) and of minimum 7mm for wider implants (implant diameter 5mm)
排除标准
- •Patient Level
- •Plaque score >20%
- •Bleeding score >20%
- •Tobacco smoking
- •Uncontrolled systemic disease
- •Use of systemic medications with an expected impact on bone healing (e.g. bisphosphonates)
- •Pregnancy or lactation
- •Lack of capacity to give an informed consent
- •Location: mandible
- •Insufficient bone volume for implant placement, requiring bone graft/augmentation
结局指标
主要结局
Implant Stability
时间窗: At implant restoration (5 months)
Implant stability Quotient (ISQ) will be measured using magnetic resonance frequency analysis (MRFA) - the device is called OSSTELL. A transducer is attached to the implant and brought to vibration by magnetic pulses from the probe of the Osstell device which makes the implant vibrate. The implant's resistance to vibration is expressed as the ISQ value. High vibration frequency signifies high implant stability.
次要结局
- Insertion torque(During procedure (implant placement))
- Marginal bone levels(At implant restoration (5 months))
研究者
Ioanna Politi
Principal Investigator
University of Dublin, Trinity College