Socket Augmentation Using Atorvastatin With Or Without PRGF (Clinical and Histomorphometric Study)
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|ClinicalTrials.gov Identifier: NCT03228771|
Recruitment Status : Completed
First Posted : July 25, 2017
Last Update Posted : September 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Socket Preservation||Drug: PRGF/ATV Drug: ATV gel||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|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)|
|Official Title:||Socket Augmentation Using Atorvastatin With Or Without PRGF Derived Fibrin Scaffold (Clinical and Histomorphometric Study)|
|Actual Study Start Date :||March 2016|
|Actual Primary Completion Date :||June 2018|
|Actual Study Completion Date :||August 15, 2018|
Active Comparator: PRGF/ATV
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).
Atorvastatin loaded in PRGF fibrin scaffold
Other Name: platelets rich in growth factors
Active Comparator: ATV gel
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.
Drug: ATV gel
Atorvastatin loaded in methyl cellulose gel
Other Name: Atorvastatin gel
No Intervention: Empty socket
Group III Empty socket( control) : Will include 10 patients undergoing single tooth extraction then suturing the socket. All patients will receive implants after taking the bone biopsy after 8 weeks for histomorphometric analysis.
- clinical measurements Ridge width [ Time Frame: 1 year ]Ridge width
- clinical measurements ridge height [ Time Frame: 1 year ]Ridge height
- histomorphometric analysis [ Time Frame: 1 year ]Bone core biopsy for histomorphometric analysis to measure osteoid tissues and mineralized bone
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03228771
|Faculty of dentistry-Ain shams University|
|Study Director:||Khaled A Ghaffar, Professor||Ain Shams University|
|Study Chair:||Ola M Ezzatt, Lecturer||Ain Shams University|