Socket Augmentation Using Atorvastatin With Or Without PRGF (Clinical and Histomorphometric Study)
Condition: Socket Preservation
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): PRGF/ATV; ATV gel
Intervention type(s): Drug; Drug
Intervention description(s): Atorvastatin loaded in PRGF fibrin scaffold; Atorvastatin loaded in methyl cellulose gel
Other intervention name(s): platelets rich in growth factors; Atorvastatin gel
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 3 Groups: Group 1: statin loaded in PRGF Group 2: statin loaded in methylcellulose gel Group 3: control
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: PRGF; Statins; socket augmentation