- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06721806
Role of Platelet Rich Plasma in Bone Regeneration After Enucleation of Odontogenic Jaw Cysts
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Jaw cysts are common lesions in the oral and maxillofacial region. Enucleation of cyst wall & curettage has evolved as the treatment of choice. In order to reduce infections and to accelerate bone regeneration, by using of Platelet rich plasma.
Platelets are involved in regeneration at sites of pathology, apart from their role in clotting. A preparation composed mainly of platelets (platelet-rich plasma gel) applied to sites of bony pathology, after surgical treatment of lesions, may hasten bone regeneration.
An interesting idea developed that the addition of a concentrate of platelets, to wounded tissues or surgical sites, may enhance the body's natural wound healing mechanisms . Platelet-rich plasma (PRP) is the accepted term to describe the preparation made out of autologous platelets suspended in autologous plasma, in concentration greater than normally found in peripheral blood Because it is autologous, PRP avoids the risk of transmissible diseases such as HIV, Hepatitis B, C or D and other blood-borne pathogens .A clot accelerator such as bovine thrombin is added to gel the PRP or PRP is added to other materials such as collagen, gelfoam, etc.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Maikel M G Morkos, dr
- Phone Number: +201271267725
- Email: Michael.16266363@med.aun.edu.eg
Study Contact Backup
- Name: Samy Masoud, prof .dr
- Email: samyosman@aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Size of the cyst more than 2 cm
- The lesion could be visualized radiographically
- Patients within the age range of 20 to 50 years
Exclusion Criteria:
- Patients who were alcoholics & smokers
- -Patients with systemic diseases
- History of bleeding tendencies, blood dyscrasia
- Low platelet count
- Patients unable or unwilling to return for follow-up
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: PRP and bone regeneration after enucleation of odontogenic jaw cysts
effect of PRP on regeneration
|
PRP effect on bone healing
|
|
Placebo Comparator: bone regeneration power without PRP
bone healing without use of PRP
|
PRP effect on bone healing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
bone healing
Time Frame: 6 months
|
effect of PRP in bone healing by measuring bone density
|
6 months
|
|
PRP & infection rate
Time Frame: 6 months
|
PRP reduce infection rate
|
6 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J, Gogly B. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part II: platelet-related biologic features. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e45-50. doi: 10.1016/j.tripleo.2005.07.009. Epub 2006 Jan 10.
- Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J, Gogly B. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part I: technological concepts and evolution. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e37-44. doi: 10.1016/j.tripleo.2005.07.008. Epub 2006 Jan 19.
- Tiwari A. A Traumatic Ulcer Caused by Accidental Lip Biting Following Topical Anesthesia: A Case Report. Cureus. 2023 Apr 29;15(4):e38316. doi: 10.7759/cureus.38316. eCollection 2023 Apr.
- Intini G. The use of platelet-rich plasma in bone reconstruction therapy. Biomaterials. 2009 Oct;30(28):4956-66. doi: 10.1016/j.biomaterials.2009.05.055. Epub 2009 Jul 1.
- Rathore A, Tiwari A, Nazim M, Gupta AK, Gande M, Krishnakumar J. Detection of Human PapillomaVirus and its Association with Potentially Malignant Disorders and Oral Squamous Cell Carcinoma: A Retrospective Study. J Pharm Bioallied Sci. 2022 Jul;14(Suppl 1):S820-S824. doi: 10.4103/jpbs.jpbs_9_22. Epub 2022 Jul 13.
- Raghavendra KM, Sara TB, Mariam VJ, Bhat GS. Author's reply: Platelet-rich fibrin as an adjunct to palatal wound healing after harvesting a free gingival graft: A case series. J Indian Soc Periodontol. 2014 Nov-Dec;18(6):684-5. doi: 10.4103/0972-124X.147397. No abstract available.
- Kulkarni MR, Thomas BS, Varghese JM, Bhat GS. Platelet-rich fibrin as an adjunct to palatal wound healing after harvesting a free gingival graft: A case series. J Indian Soc Periodontol. 2014 May;18(3):399-402. doi: 10.4103/0972-124X.134591.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRP & bone healing
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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