Bone Regeneration Using PRF After Cyst Enucleation
PRF-Bone
Clinical Efficacy of Platelet-Rich Fibrin in Osseous Regeneration After Cystic Enucleation
1 other identifier
interventional
20
1 country
1
Brief Summary
This randomized controlled clinical trial aims to evaluate the clinical efficacy of autologous platelet-rich fibrin (PRF) in promoting osseous regeneration following cystic enucleation in the jaws. The study will assess bone healing outcomes and compare PRF application with conventional management methods.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 19, 2025
CompletedFirst Submitted
Initial submission to the registry
February 14, 2026
CompletedFirst Posted
Study publicly available on registry
February 20, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 19, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
October 19, 2026
ExpectedFebruary 20, 2026
February 1, 2026
11 months
February 14, 2026
February 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Radiographic bone regeneration in cystic defects following enucleation
The amount of bone regeneration will be evaluated radiographically using CBCT imaging to measure the percentage of defect fill and bone density changes at 6 months postoperatively.
6 months after surgery
Study Arms (2)
PRF Group
EXPERIMENTALParticipants undergoing cystic enucleation in the jaws will receive autologous Platelet-Rich Fibrin (PRF) placed into the osseous defect immediately after surgical enucleation.
Control Group
ACTIVE COMPARATORParticipants undergoing cystic enucleation of jaw cysts will receive conventional surgical management without the application of platelet-rich fibrin (PRF). The osseous defect will be left to heal naturally following standard enucleation and wound closure procedures.
Interventions
Autologous platelet-rich fibrin (PRF) prepared from the participant's own venous blood will be placed into the osseous defect immediately after cystic enucleation. PRF will be prepared using standard centrifugation protocols and applied to promote bone regeneration.
Conventional cystic enucleation will be performed without the use of platelet-rich fibrin (PRF). The osseous defect will be managed according to standard surgical protocol and allowed to heal naturally.
Eligibility Criteria
You may qualify if:
- Patients diagnosed with odontogenic cysts requiring surgical enucleation.
- Presence of a postoperative osseous defect in the jaws after cyst enucleation.
- Age ≥ 18 years.
- Systemically healthy patients (ASA I or II).
- Patients willing to participate and sign informed consent.
You may not qualify if:
- Patients with systemic diseases affecting bone healing (e.g., uncontrolled diabetes, osteoporosis).
- Patients receiving bisphosphonates or long-term corticosteroid therapy.
- Smokers (\>10 cigarettes/day).
- Pregnant or lactating women.
- Patients with acute infection at the surgical site.
- Patients unwilling to participate or unable to attend follow-up visits.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine and Health Sciences - Sana'a University
Sanaa, Sana'a Governorate, 00000, Yemen
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- This is an open-label study. Participants, care providers, and investigators are aware of the assigned intervention (PRF or control). No masking is used.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Master's Degree Candidate, Faculty of Dentistry, Sana'a University
Study Record Dates
First Submitted
February 14, 2026
First Posted
February 20, 2026
Study Start
May 19, 2025
Primary Completion
April 19, 2026
Study Completion (Estimated)
October 19, 2026
Last Updated
February 20, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
- Time Frame
- De-identified individual participant data (IPD) will be made available beginning 6 months after publication of the primary study results and will remain available for a period of 5 years. Supporting documents, including the study protocol, statistical analysis plan (SAP), clinical study report (CSR), and analytic code, will be available during the same time frame.
- Access Criteria
- Access to de-identified individual participant data will be granted to qualified researchers who provide a methodologically sound research proposal. Requests must include a detailed analysis plan and will be subject to review and approval by the principal investigator and the institutional research committee. Data will be shared under a data use agreement to ensure participant confidentiality and compliance with ethical standards. Data will be made available via secure electronic transfer.
De-identified individual participant data (IPD) underlying the results reported in this study will be shared. The shared data will include demographic characteristics (age, sex), clinical findings, cyst size and location, surgical details, intervention allocation (PRF vs control), radiographic measurements of bone regeneration, and follow-up outcome data. All data will be fully anonymized prior to sharing to ensure participant confidentiality. Supporting documents, including the study protocol, statistical analysis plan (SAP), and analytic code, may also be made available upon reasonable request.