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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
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| Empty socket | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRGF/ATV | Drug | Atorvastatin loaded in PRGF fibrin scaffold |
|
| Measure | Description | Time Frame |
|---|---|---|
| clinical measurements Ridge width | Ridge width | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| clinical measurements ridge height | Ridge height | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| histomorphometric analysis | Bone core biopsy for histomorphometric analysis to measure osteoid tissues and mineralized bone | 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Khaled A Ghaffar, Professor | Ain Shams University | Study Director |
| Ola M Ezzatt, Lecturer | Ain Shams University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of dentistry-Ain shams University | Cairo | Egypt |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 10, 2019 | |
| Reset | Jul 18, 2019 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 18, 2015 | Jul 10, 2017 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 18, 2015 | Jul 22, 2017 | SAP_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 18, 2015 | Jul 22, 2017 | SAP_002.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 10, 2019 | Jul 18, 2019 |
| ID | Term |
|---|---|
| D036341 | Intercellular Signaling Peptides and Proteins |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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3 Groups: Group 1: statin loaded in PRGF Group 2: statin loaded in methylcellulose gel Group 3: control
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| ATV gel | Drug | Atorvastatin loaded in methyl cellulose gel |
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