Assessing Osteogenic Activity in Injectable Platelet Rich Fibrin Coated Implants Using Bone-specific Alkaline Phosphatase Biomarker An Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- To evaluate the levels of BALP in PISF of implants coated with i-PRF
研究概览
简要总结
This observational study will aim to evaluate the osteogenic potential of dental implants coated with injectable Platelet-Rich Fibrin (i-PRF) by assessing levels of Bone-specific Alkaline Phosphatase (BALP), a biomarker indicative of bone formation activity.
A total of 28 systemically healthy patients, aged between 20 and 65 years and requiring implant placement, will be selected and randomly divided into two groups:
- Test Group (n=14): Will receive implants coated with i-PRF.
- Control Group (n=14): Will receive implants without any coating.
All implant procedures will be performed following standard surgical protocols. Peri-implant sulcular fluid (PISF) will be collected from each patient at 2, 4, and 8 weeks following implant placement. The levels of BALP in these samples will be analyzed using an enzyme-linked immunosorbent assay (ELISA) to compare osteogenic activity between the coated and uncoated implant groups.
The application of i-PRF, an autologous blood derivative rich in growth factors, is expected to enhance early osseointegration by promoting osteoblastic activity and bone formation. This study will aim to provide further insight into the clinical advantages of bioactive surface coatings in improving implant success and reducing healing time.
Statistical analysis will be performed using SPSS v21.0 to determine any significant differences in BALP levels across time intervals and between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Sufficient bone width and height available for placement of implant Adequate oral hygiene maintenance.
排除标准
- •Presence of active periodontal disease History of smoking or tobacco consumption Pregnant & lactating females Patient with bone related disorders Patients on medication like bisphosphonates calcium supplements Patient with psychiatric disorders Uncontrolled bleeding disorders Uncontrolled systemic diseases.
结局指标
主要结局
To evaluate the levels of BALP in PISF of implants coated with i-PRF
时间窗: 2, 4 and 8 weeks after implant placement
To evaluate the levels of BALP in PISF of implants without i-PRF coating
时间窗: 2, 4 and 8 weeks after implant placement
To inter-compare the levels of BALP in PISF of implants with and without i-PRF coating at 2, 4 and 8 weeks of implant placement
时间窗: 2, 4 and 8 weeks after implant placement
次要结局
- To evaluate the levels of BALP in PISF of implants coated with i-PRF(2, 4 and 8 weeks after implant placement)
研究者
Dr Bhavya Agarwal
Institute of Dental Sciences Bareilly
