A Randomised Control Clinical Trial Investigating the Effect of Horizontal-Platelet-Rich Fibrin (H-PRF) vs Standard Placement on Implant Stability and Marginal Bone Levels in Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Primary outcome: Implant Stability Quotient (ISQ) using magnetic resonance frequency analysis (MRFA)
研究概览
简要总结
This research will be a randomised controlled trial (RCT) investigating whether the use of Horizontal Platelet Rich Fibrin (H-PRF) increases implant stability compared to those implants placed without H-PRF, and therefore, contributes to the implant's overall success.
H-PRF is a second generation platelet concentrate that consists of a fibrin mesh containing cytokines and leukocytes. It has been shown to stimulate mesenchymal stem cells and osteoblasts that encourage bone formation as a result of the growth factors released from platelets, which should aid in osseointegration of implants. There is limited research that investigates the effects of H-PRF on implant stability. There is, however, some evidence that platelet-rich fibrin (PRF), which is produced in a fixed-angle centrifuge, increases implant stability and H-PRF is considered the evolution of PRF products.
This research would follow a H-PRF preparation protocol which involves taking a sample of venous blood from patients using a butterfly needle to collect up to 8-9ml tubes of blood. After the tube of blood is collected, it would immediately be placed in a horizontal centrifuge machine with 3 tubes of water to balance the centrifuge, and placed opposite each other. A set rpm and time will be chosen, and the centrifuge will run until the time is complete. The H-PRF clots would then be ready and taken out of the tubes to separate them from the red blood cells.
Following randomisation, implants will be placed in the upper or lower jaws of patients attending the Dublin Dental University Hospital using the standard implant protocol. Half of the implants will be coated with H-PRF, the other half (control group) would be placed without HPRF. Implant stability and marginal bone levels will be measured at three different stages: 1) Initial implant placement, 2) Second stage surgery when the implant is uncovered after healing and integrated with the bone, 3) When the definitive crown or bridge is attached to the implant. Insertion torque at baseline will also be measured. The above results will be collected and assessed to determine the effects of H-PRF, if any, on implant stability and the preservation of bone levels around implants.
详细描述
This is a parallel arm, randomised control clinical Trial (RCT) on a cohort of Dublin Dental University Hospital patients who are having dental implants placed in the maxilla or mandible.
Study sample:
- Subjects will be recruited from a population of patients who have been referred to Dublin University Dental Hospital from general practice or specialist practice for provision of implants
- Subjects will be recruited from a population of patients who have been referred from another department within the Dublin Dental Hospital for provision of implants.
Enrolment and Consent:
Participants will be selected via two methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
Due to the nature of having to draw blood from participants who will be receiving H-PRF, nobody can be masked/blinded
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 and willing to maintain a diary of symptoms
- •Planned for provision of dental implant(s) at Dublin Dental University Hospital Site Level
- •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 capacity to give informed consent
- •History of radiotherapy to the head and/or neck Site Level
- •Insufficient bone volume for implant placement, requiring bone graft/augmentation
结局指标
主要结局
Primary outcome: Implant Stability Quotient (ISQ) using magnetic resonance frequency analysis (MRFA)
时间窗: At implant placement, at 3 months and at 4-5 months (implant restoration)
This is a measurement of the stability of the implant
次要结局
- Rate of pain experienced based on a visual analog scale 1-10(after local anaesthetic wears away, 24 hours after implant placement and 1 week after implant placement)
- Secondary outcomes: Marginal bone levels(At implant placement, at 3 months and at 4-5 months (implant restoration))
- Number of participants with implant loss/fracture/infection(At any point from implant placement until 4-5 months afterwards)
研究者
Rawan Kahatab
Postgraduate periodontology student
University of Dublin, Trinity College