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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Shiraz University of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Reza Tabrizi, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01944410
First received: September 10, 2013
Last updated: September 12, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Traumatic Bone Cyst
Biological: PRP injection
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Platelet-rich Plasma in Treatment of Mandibular Traumatic Bone Cyst

Further study details as provided by Shiraz University of Medical Sciences:

Primary Outcome Measures:
  • Fulfill bone cyst defect [ Time Frame: : 6 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Evaluate effect of PRP injection to fulfill the defect of bone cyst and decrease size of the lesion


Estimated Enrollment: 12
Study Start Date: January 2013
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: traumatic bone cyst
Patients with traumatic bone cyst defect are injected with PRP
Biological: PRP injection
injection of PRP to traumatic bone cyst defect
Other Name: growth factor injection

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.

  Eligibility

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01944410

Contacts
Contact: reza tabrizi, DMD 09125850829 TABMED@GMAIL.COM

Locations
Iran, Islamic Republic of
RE Recruiting
Shiraz, CMF ward , Chamran hospital , Chamran avenue., Iran, Islamic Republic of
Contact: reza tabrizi, DMD    09125850829    TABMED@GMAIL.COM   
Principal Investigator: reza tabrizi, DMD         
Sponsors and Collaborators
Shiraz University of Medical Sciences
Investigators
Study Chair: Reza Tabrizi, DMD SUMS
Study Director: Reza Tabrizi, DMD SUMS
Study Director: Shole shahidi, DDS SUMS
Principal Investigator: Touba Karagah, DMD SUMS
Principal Investigator: Nasibeh Zare, DDS SUMS
  More Information

No publications provided

Responsible Party: Reza Tabrizi, oral and maxillofacial surgeon, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01944410     History of Changes
Other Study ID Numbers: 1234, 12345sums
Study First Received: September 10, 2013
Last Updated: September 12, 2013
Health Authority: Iran: Ethics Committee

Keywords provided by Shiraz University of Medical Sciences:
PRP
TBC
Treatment

Additional relevant MeSH terms:
Bone Cysts
Cysts
Neoplasms
Bone Diseases
Musculoskeletal Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 31, 2014