Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03003013 |
| Other study ID # |
CU |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
November 2016 |
| Est. completion date |
December 2018 |
Study information
| Verified date |
July 2018 |
| Source |
Cairo University |
| Contact |
Sherif AbdelMonem Abdel Aziz, B.D.S. |
| Phone |
(+002)01009026713 |
| Email |
dr_sherifelsaraf[@]yahoo.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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
Description:
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:
- Extremely long.
- Complex protocols. 3. Platelet rich plasma (PRP): It is a modification type of
autologous fibrin adhesives which requires autologous blood collection in the immediate
preoperative period and processing in the centrifugation which is then mixed with bovine
thrombine and calcium chloride at the time of application.
Shortcomings:
1. The use of bovine thrombin puts the patient at risk of life -threating coagulopathies
associated with the development of antibodies to factor V , XI and thrombin .
2. Higher concentration of thrombin impedes cell migration during bone healing.
3. It mediates only the early aspects of bone repair. A variety of treatment modalities
including the use of autogenous bone grafts and bone substitutes materials ,guided
tissue regeneration (GTR) with the use of barrier membranes and growth factors have been
used to stimulate bone regeneration mechanism.The drawbacks associated with autogenous
bone grafts have led to the production of a large number of alternative bone substitute
materials. Their biological behavior depends upon their chemical composition and
physicochemical structure. Bone grafting materials include autografts, allografts,
xenografts and alloplasts. The osteoconductive hydroxyapatite grafting materials have
been widely used to enhance new bone regeneration.
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:
1. The improved mechanical properties of PRF over conventional PRP translate it into a
biologic matrix that is easy to handle and implant in awide variety of tissue repair
applications.
2. Platelets rich fibrin has increased modulus of elasticity. This property imparts it
better pliability and drapability, allowing it to closely conform to awide variety of
irregular surgical sites and surfaces similar to split thickness skin auto grafts.
3. Platelet rich fibrin can easily be sutured to surgical site.
Benefits of this study to patients:
- Treatment of cystic lesions.
- Enhancement of bone regeneration.
Benefits of this study for other clinicians:
The study provides a new modality for the regeneration of new bone after cystic enucleation.
