Use of PRP in Treatment of Mandibular Traumatic Bone Cyst

NCT01944410 | Completed Phase 1 DMC

• 2 other identifiers: 123412345sums
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Bone Cyst

Keywords

PRP; TBC; Treatment

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• effect of PRP

  6 months

Study Arms (1)

traumatic bone cyst

EXPERIMENTAL

Patients with traumatic bone cyst defect are injected with PRP

Biological: PRP injection

Interventions

PRP injection BIOLOGICAL

injection of PRP to traumatic bone cyst defect

Also known as: growth factor injection

traumatic bone cyst

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead

Study Sites (1)

RE

Shiraz, CMF Ward , Chamran Hospital , Chamran Avenue., Iran

Location

MeSH Terms

Conditions

Bone Cysts

Interventions

Intercellular Signaling Peptides and Proteins

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Reza Tabrizi, DMD

  SUMS

  STUDY CHAIR

• Reza Tabrizi, DMD

  SUMS

  STUDY DIRECTOR

• Shole shahidi, DDS

  SUMS

  STUDY DIRECTOR

• Touba Karagah, DMD

  SUMS

  PRINCIPAL INVESTIGATOR

• Nasibeh Zare, DDS

  SUMS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: oral and maxillofacial surgeon

Study Record Dates

• First Submitted: September 10, 2013
• First Posted: September 17, 2013
• Study Start: January 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: April 1, 2014
• Last Updated: October 7, 2014

Record last verified: 2014-10

Locations

IR (1)