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临床试验/NCT03228771
NCT03228771已完成4 期

Socket Augmentation Using Atorvastatin With Or Without PRGF Derived Fibrin Scaffold (Clinical and Histomorphometric Study)

Ain Shams University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
30
试验地点
1
主要终点
clinical measurements Ridge width

研究概览

简要总结

Despite the numerous studies describing the benefits of PRGF (plasma rich in growth factors) and Statins separately , there has been a lack of clinical investigation into the simultaneous use of these agents in socket augmentation. Therefore the main objective of this study is to evaluate socket bone dimensions and quality following the use of PRGF derived fibrin scaffold as a carrier for Atorvastatin in socket augmentation clinically and histomorphometrically.

详细描述

Despite the numerous studies describing the benefits of PRGF (plasma rich in growth factors) and Statins separately , there has been a lack of clinical investigation into the simultaneous use of these agents in socket augmentation.

Plasma Rich in Growth Factors (PRGF) have given rise to an optimized and safer product rich in growth factors which might be essential to proper tissue repair and wound healing. PRGF acts on already differentiated cells, such as preosteoblasts and osteoblasts. However , they do not exert any effects on the stem cells present in bone tissue, whose differentiation is regulated by bone morphogenetic proteins (BMPs). Some pharmacologic compounds could offer a safe and cost effective alternative to this problem and can affect bone regeneration. Statins are widely used group of cholesterol lowering drugs that act on the mevalonate pathway by being a competitive inhibitors of the rate limiting enzyme 3-hydroxy-3-methylglutaryl coenzyme A (CoA) reductase (HMG-CoA reductase). Statins increase normal bone formation by promoting osteoblast proliferation and differentiation and protecting the osteoblasts from apoptosis. In addition, they reduce osteoclastogenesis by inhibiting osteoclastic differentiation. Statins increase BMP-2 gene expression and subsequently promote bone formation.This study hypothesized that use of PRGF fibrin scaffold in socket preservation owing to its biocompatibility, ease of use, stimulation of production of growth factors and its effect on the already differentiated osteoblasts, when combined with statin with its effect on progenitor stem-cells could stimulate the differentiation of stem cells to osteoblasts, prevent bone resorption and stimulate bone formation at the extraction socket. Therefore the main objective of this study is to evaluate socket bone dimensions and quality following the use of PRGF derived fibrin scaffold as a carrier for Atorvastatin in socket augmentation clinically and histomorphometrically.

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 (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy adult patients as evidenced by Burkett's oral medicine health history questionnaire.
  • Both sexes.
  • Age from 20 - 50 years old.
  • Having at least one hopeless tooth indicated for extraction.
  • Patient should agree to sign a written consent after the nature of the study will be explained.

排除标准

  • Pregnant and breast feeding females.
  • Prisoners and handicapped patients.

研究组 & 干预措施

ATV gel

Active Comparator

Group II (ATV gel) : Will include 10 patients undergoing single tooth extraction followed by socket fill with 1.2% Atorvastatin in methyl cellulose gel then suturing the socket. All patients will receive implants after taking the bone biopsy after 8 weeks for histomorphometric analysis.

干预措施: ATV gel (Drug)

PRGF/ATV

Active Comparator

Group I (PRGF/ATV) : It was included 10 patients undergoing single tooth extraction followed by socket fill with 1.2% Atorvastatin loaded in PRGF derived fibrin scaffold then suturing the socket. All patients will receive implants after taking the bone biopsy after 8 weeks for histomorphometric analysis.

Intervention: Atorvastatin drug loaded in platelets rich in growth factors (PRGF).

干预措施: PRGF/ATV (Drug)

结局指标

主要结局

clinical measurements Ridge width

时间窗: 1 year

Ridge width

次要结局

  • clinical measurements ridge height(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Noha Nasr

Researcher

Ain Shams University

研究点 (1)

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