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临床试验/CTRI/2023/08/056520
CTRI/2023/08/056520尚未招募3 期

Clinical and Radiographic evaluation of Implant Stability and crestal bone levels of dental implants with and without injectable Platelet Rich Fibrin (i-PRF) – A Randomized Control Study

Dr Komali Kasukurthi1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年8月26日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
Implant Stability And Crestal Bone Levels

研究概览

简要总结

NEED FOR THE STUDY:

Successful osseointegration is the first step in long-term survival and stability of a dental implant. Surface modifications by implant manufacturers are aimed at improving the bone-implant contact and another technique for improving the bone-implant contact and reducing osseointegration time could be represented by the use of autologous blood derivatives that contain a rich supply of growth factors and bone-specific proteins*.*1

Injectable platelet-rich fibrin (i-PRF) is the most recent and successful advancement in PRF and is beneficial for bone augmentation of the alveolar ridge prior to or during implant placement and wound healing.2

Use of i-PRF as a surface coating performed as a chairside procedure to coat the surface of the implant just prior to placement can be implemented to improve osseointegration. It could possibly serve as a simple, economical, and effective way of ensuring better implants success and quicker treatment time. As it is in a liquid formulation, it can be evenly applied all over the implant surface.1

The scientific data regarding the i-prf coated implants is inadequate. Hence, the present study is designed to evaluate and compare implants with and without i-PRF coating.

SURFACE COATING OF IMPLANT WITH i-PRF:

Ø  The osteotomy sites will be prepared using standard sequential drilling protocol for the full sequence.

Ø  Just before implant placement the i-PRF will be prepared.

Ø  For i-PRF preparation,10 ml of whole blood without anticoagulant will be centrifuged at 700 rpm for 3 min at room temperature. 3

Ø  After 3 mins the straw-colored liquid present at the top which is i-PRF will be collected.

Ø  1.5 ml of i-PRF liquid will be used to coat the implants by dipping in i-PRF.

RESEARCH QUESTION - Does implant with i-PRF will have better implant stability and crestal bone levels when compared to implants without i-PRF?

RESEARCH HYPOTHESIS [H1] - Implant with i-PRF may have better implant stability and crestal bone levels when compared to implants without i-PRF.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Outcome Assessor Blinded

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients of age group
  • 60 years. 2.Patients with single edentulous sites in either jaw. 3.Absence of restoration/prosthesis adjacent to edentulous site. 4.Healed extraction socket site ≥ 3 months.

排除标准

  • 1.Patients with systemic diseases.
  • 3.Pregnant or lactating women.

结局指标

主要结局

Implant Stability And Crestal Bone Levels

时间窗: Base line & | 3 MONTHS

次要结局

未报告次要终点

研究者

发起方
Dr Komali Kasukurthi
申办方类型
Other [self ]

研究点 (1)

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