PRGF/ATV
Combination ProductAtorvastatin (ATV) loaded on plasma rich in growth factor (PRGF) Derived Fibrin Scaffold
NCT Number: NCT03231137
This study was conducted to compare post-extraction augmented sockets using Atorvastatin loaded in Plasma rich in growth factors derived fibrin scaffold (PRGF/ATV) or direct application of Atorvastatin (ATV) gel or platelet rich fibrin (PRF) or (PRGF) and spontaneously healed socket (Control) both clinically and by histomorphometric analysis of formed bone quality.
Looking for future studies?
Notify Me20 year–50 year
All sexes
Interventional
Phase 4
Ridge preservation therapies have been proposed with the aim of maintaining the hard and soft tissue dimensions of the alveolar ridge that are partially lost after tooth extraction as part of the natural physiological healing process. There are many techniques in the literature used for socket preservation as bone grafts, barrier membranes, immediate implant and socket shield. Many other techniques also are used such as bone and tissue healing promoting molecules like recombinant human bone morphogenetic protein-2 (rhBMP-2). However Autologous blood preparations like platelet-rich fibrin (PRF), and platelet rich in growth factors (PRGF) have been also introduced for socket preservation. Moreover, Statins the widely used group of cholesterol lowering drugs which also increase normal bone formation by promoting osteoblast proliferation and differentiation and protecting the from apoptosis. In addition, they reduce osteoclastogenesis by inhibiting osteoclastic differentiation. Statins increase BMP-2 gene expression and subsequently promote bone formation. in the emerging area of growth factors, there is no high-quality evidence to either support or refuse their use.
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Atorvastatin (ATV) loaded on plasma rich in growth factor (PRGF) Derived Fibrin Scaffold
Atorvastatin gel
Platelet rich fibrin
plasma rich in growth factor
Time frame: baseline (immediately after extraction) - After 2 months
(Measured from stent reference point to the crest of the buccal or palatal plate of bone)
Time frame: baseline (immediately after extraction) - After 2 months
(Measured from the buccal to palatal plate of bone using bone caliper)
Time frame: after 2 months
Time frame: after 2 months
Ain Shams University
Other
Socket Augmentation Using Different Platelet Concentrates, Atorvastatin Gel or Combination (Clinical and Histomorphometric Study)
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.