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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01944410
Recruitment Status : Completed
First Posted : September 17, 2013
Last Update Posted : October 7, 2014
Information provided by (Responsible Party):
Reza Tabrizi, Shiraz University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Traumatic Bone Cyst Biological: PRP injection Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Platelet-rich Plasma in Treatment of Mandibular Traumatic Bone Cyst
Study Start Date : January 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : April 2014

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Fulfill bone cyst defect [ Time Frame: : 6 months ]
    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 :
  1. effect of PRP [ Time Frame: 6 months ]
    Evaluate effect of PRP injection to fulfill the defect of bone cyst and decrease size of the lesion

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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01944410

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Iran, Islamic Republic of
Shiraz, CMF ward , Chamran hospital , Chamran avenue., Iran, Islamic Republic of
Sponsors and Collaborators
Shiraz University of Medical Sciences
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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

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Responsible Party: Reza Tabrizi, oral and maxillofacial surgeon, Shiraz University of Medical Sciences Identifier: NCT01944410     History of Changes
Other Study ID Numbers: 1234
12345sums ( Other Grant/Funding Number: shiraz university of medical sciences )
First Posted: September 17, 2013    Key Record Dates
Last Update Posted: October 7, 2014
Last Verified: October 2014

Keywords provided by Reza Tabrizi, Shiraz University of Medical Sciences:

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