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NCT Number: NCT03228771

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

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.

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Key information

Conditions

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of dentistry-Ain shams University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

PRGF/ATV

Drug

Atorvastatin loaded in PRGF fibrin scaffold

Other names: platelets rich in growth factors

ATV gel

Drug

Atorvastatin loaded in methyl cellulose gel

Other names: Atorvastatin gel

Primary outcomes

  1. clinical measurements Ridge width

    Time frame: 1 year

    Ridge width

Secondary outcomes

  1. clinical measurements ridge height

    Time frame: 1 year

    Ridge height

Other outcomes

  1. histomorphometric analysis

    Time frame: 1 year

    Bone core biopsy for histomorphometric analysis to measure osteoid tissues and mineralized bone

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jul 25, 2017
Registry last updated
Sep 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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