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临床试验/CTRI/2025/07/090179
CTRI/2025/07/090179尚未招募不适用

Assessing Osteogenic Activity in Injectable Platelet Rich Fibrin Coated Implants Using Bone-specific Alkaline Phosphatase Biomarker An Observational Study

Institute of Dental Sciences Bareilly1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2025年7月18日最近更新:

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

发起方
Institute of Dental Sciences Bareilly
申办方类型
Other [Institute of Dental Sciences Bareilly]
责任方
Principal Investigator
主要研究者

Dr Bhavya Agarwal

Institute of Dental Sciences Bareilly

研究点 (1)

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