Traumatic Bone Cyst Clinical Trial
— TBCOfficial title:
Efficacy of Platelet-rich Plasma in Treatment of Mandibular Traumatic Bone Cyst
| Verified date | October 2014 |
| Source | Shiraz University of Medical Sciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Iran: Ethics Committee |
| Study type | Interventional |
The traumatic bone cyst (TBC) is an infrequent nonepithelial lined cavity of the jaws, which
was first expressed by lucassin 1929, the lesion has attracted a great deal of interest in
the dental literature, but its pathogenesis is still not evidently recognized. It determines
a bone cavity of irregular shape which appears like a cyst on a radiograph, and
histopathologically there are no elements to confirm a diagnosis of a cysts. TBC the
international histological classification assumed by the World Health Organisation for
odontogenic tumours utilizes the term "solitary bone cyst", nevertheless the term "traumatic
bone cyst" (TBC) is more extensively used in the literature. The WHO classification explains
TBC as a non-neoplastic osseous lesion because it demonstrates no epithelial lining, which
differentiates this lesion from the true cysts. There is general conformity that most
traumatic bone cysts present without symptoms or signs. Seldom, expansion of the cortical
plate may occur with extraoral swelling, less commonly there may erosion through the
cortical bone may take place.' Teeth in the area of involved bone usually remain vital,
without root resorption or tooth mobility. Treatment of traumatic bone cysts has included
surgical exploration and curettage to motivate bleeding within the bony cavity,' packing of
the cyst cavity with Gelfoam which has been saturated with thrombin and penicillin, and bone
grafting based on previous study Injection of autogeneic blood into the bony cavity of a
traumatic bone cyst was followed by rapid resolution of the lesion.
Platelet-rich plasma (PRP) is a rich source of growth factors. The growth factors present in
PRP are familiar, including transforming growth factor-_ (TGF-_1 and TGF-_2), vascular
endothelial growth factor, 3 isomers of platelet-derived growth factor (PDGF-__,PDGF-__, and
PDGF-__), and endothelial growth factor. These growth factors are considered to have the
capacity to accelerate chemotaxis, mitogenesis, angiogenesis, and synthesis of collagen
matrix and support tissue repair when applied on bone wounds. Due to this high platelet
content, PRP has been used in orthopaedic surgery, oral implantology, and periodontics with
the aim of making the repair process as fast and natural as possible, as it can potentially
afford considerable tissue improvement in bone and soft tissue in a similar way. PRP is
easily acquired, rich in cell signalling molecules, completely autogenous and can be
obtained from minimal blood volumes.the purpose of the present study is to determine the
efficacy of PRP in the treatment of mandibular TBC.
| Status | Completed |
| Enrollment | 12 |
| Est. completion date | April 2014 |
| Est. primary completion date | January 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 15 Years to 65 Years |
| Eligibility |
Inclusion Criteria: Traumatic Bone cyst diagnosed with panoramic X-Ray and histopathologic evaluation - Intact cyst wall with high risk for fracture - Patients of both sexes between 15 to 65 year's old - Patients who are willing for evaluation in 2,4 and 6 months after surgery Patients who are willing for Laboratory tests . Provided written consent form - Patients who agree to take xray in 2,4 and 6 months after surgery for radiographic evaluation Exclusion Criteria: - Patients who unable to undergo oral surgery - Patients using systemic drugs or presenting a medical history positive for any systemic pathology history of hypersensitivity to any component used in the methodology Pregnant patients - Smokers - Patients who can not continue the study for private or social reasons |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Iran, Islamic Republic of | RE | Shiraz | CMF ward , Chamran hospital , Chamran avenue. |
| Lead Sponsor | Collaborator |
|---|---|
| Shiraz University of Medical Sciences |
Iran, Islamic Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Fulfill bone cyst defect | change in size of the defect of bone will be measured by millimeter on radiographic examination in 2,4.6 months after PRP injection and will be compared with initial size of the defect | : 6 months | Yes |
| Secondary | effect of PRP | Evaluate effect of PRP injection to fulfill the defect of bone cyst and decrease size of the lesion | 6 months | Yes |