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Effect of Biphasic Bone Graft Material (BGM) in combination with autologous platelet-rich fibrin (PRF) on bone regeneration in an odontogenic maxillary cyst: a randomized clinical trial
Odontogenic cysts are the most common form of cystic lesions that affect the oral and maxillofacial region. Their origin, mechanism of growth, as well as treatment problems have been often discussed.
Platelet rich fibrin (PRF) is a second generation platelet concentrate first developed in France by Choukron et al in 2001, prepared from centrifuged autologous blood. It is a fibrin clot rich in platelets without addition of bovine thrombin, calcium chloride or anticoagulant during preparation thus eliminating the risks associated with the use of thrombin. Platelet rich fibrin is derived from a natural and progressive polymerization occurring centrifugation. A progressive or relatively slow polymerization mode may increase incorporation of the circulating cytokines in the fibrin meshes which are then released in a relatively long-term and controllable way which in turn will help in soft tissue healing and accelerated bone regeneration.
Blood Derivatives Enhancing Bone Regeneration:
1-Fibrin glue: It is classically described as a two component mixture in which concentrated fibrinogen factor XIII and fibronectin are added to thrombin ,calcium choloride and an inhibitor of fibrinolysis to form a fibrin clot .
Shortcomings:
The risk of transmission of virus, like human immunodeficiency virus (HIV). 2. Autologous Fibrin Adhesives: The patient's blood is harvested 1:3 weeks before the intervention and requires separating one unit of whole blood cell component and plasma fraction for use as cryoprecipitate.
Shortcomings:
Shortcomings:
SYMBIOS®:
Biphasic Bone Graft Material (BGM) is a resorbable inorganic bone forming material in granular form of plant origin derived from red marine algae. The chemical composition of this interconnected porous biological product is similar to the inorganic part of the human bone. It is a composition of 20% hydroxyapatite (HA) and 80% β-tricalciumphosphate (ß-TCP). Due to the high tricalcium- phosphate content of the product it resorbs significantly faster than pure hydroxyapatite. The biphasic BGM is biocompatible and osteoconductive. The selection of the two grain sizes is dependent on the defect.
Growth factors represent an area of interest for surgeons attempting to modify and enhance the wound healing process and tissue regeneration. However, the Platelet-Rich Plasma (PRP) is already in use for some time by hematologists for transfusions and prevention of bleeding episodes in patients with severe thrombocytopenia.
Uses of PRF Over PRP:
Benefits of this study to patients:
Benefits of this study for other clinicians:
The study provides a new modality for the regeneration of new bone after cystic enucleation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biphasic Bone Graft With Autologous Platelet-rich Fibrin | Active Comparator | Patients will undergo complete removal of the cystic cavity with the application of SYMBIOS biphasic bone graft material in combination with PRF in the cystic cavity |
|
| Biphasic Bone Graft Material only | Active Comparator | Patients will undergo complete removal of the cystic cavity with the application of SYMBIOS biphasic bone graft material without PRF in the cystic cavity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biphasic Bone Graft Material (BGM) in Combination With Autologous Platelet-rich Fibrin (PRF) | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Swelling | Visual analogue scale | six weeks |
| Measure | Description | Time Frame |
|---|---|---|
| bone regeneration | Gray scale value via cone beam CT | from six to nine months |
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Inclusion Criteria:
Inclusion criteria
Exclusion criteria
Exclusion Criteria:
-
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sherif AbdelMonem Abdel Aziz, B.D.S. | Contact | (+002)01009026713 | dr_sherifelsaraf@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Niven Abal Latif Askar, PhD | Assistant Professor of Oral& Maxillofacial Surgery | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Oral & Dental Medicine Cairo University | Recruiting | Cairo | Egypt |
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| ID | Term |
|---|---|
| D009807 | Odontogenic Cysts |
| ID | Term |
|---|---|
| D007570 | Jaw Cysts |
| D001845 | Bone Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
| D009057 | Stomatognathic Diseases |
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