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Use of PRP in Treatment of Mandibular Traumatic Bone Cyst (TBC)

Primary Purpose

Traumatic Bone Cyst

Status
Completed
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
PRP injection
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Bone Cyst focused on measuring PRP, TBC, Treatment

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • RE

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

traumatic bone cyst

Arm Description

Patients with traumatic bone cyst defect are injected with PRP

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

effect of PRP
Evaluate effect of PRP injection to fulfill the defect of bone cyst and decrease size of the lesion

Full Information

First Posted
September 10, 2013
Last Updated
October 5, 2014
Sponsor
Shiraz University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01944410
Brief Title
Use of PRP in Treatment of Mandibular Traumatic Bone Cyst
Acronym
TBC
Official Title
Efficacy of Platelet-rich Plasma in Treatment of Mandibular Traumatic Bone Cyst
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shiraz University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
The study sample consisted of 12 young adult volunteers presenting with TBC of mandible. Local ethical committee approval will be obtained before the trial starts. Laboratory tests (complete blood count, glucose, creatinine, platelets, lipid profile) were performed for all patients. These tests provided an important overview of patient health and a baseline for analysis of the prognosis of PRP use. The process for obtaining PRP basically consists of collection of a 20-mL sample of blood, centrifugation of this sample for 8 min, isolation of a 1-mL aliquot of plasma collected near the erythrocyte fraction. Surgical procedure includes: surgical exploration and injection of PRP to stimulate bone regeneration within the bony cavity . Bone repair was assessed by panoramic X-rays obtained at 2, 4, and 6 months postoperatively. Bone density was measured by area histogram analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Bone Cyst
Keywords
PRP, TBC, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
traumatic bone cyst
Arm Type
Experimental
Arm Description
Patients with traumatic bone cyst defect are injected with PRP
Intervention Type
Biological
Intervention Name(s)
PRP injection
Other Intervention Name(s)
growth factor injection
Intervention Description
injection of PRP to traumatic bone cyst defect
Primary Outcome Measure Information:
Title
Fulfill bone cyst defect
Description
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
Time Frame
: 6 months
Secondary Outcome Measure Information:
Title
effect of PRP
Description
Evaluate effect of PRP injection to fulfill the defect of bone cyst and decrease size of the lesion
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reza Tabrizi, DMD
Organizational Affiliation
SUMS
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Reza Tabrizi, DMD
Organizational Affiliation
SUMS
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Shole shahidi, DDS
Organizational Affiliation
SUMS
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Touba Karagah, DMD
Organizational Affiliation
SUMS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nasibeh Zare, DDS
Organizational Affiliation
SUMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
RE
City
Shiraz
State/Province
CMF ward , Chamran hospital , Chamran avenue.
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

Use of PRP in Treatment of Mandibular Traumatic Bone Cyst

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