Bone Regeneration Using PRF After Cyst Enucleation (PRF-Bone)

Clinical Efficacy of Platelet-Rich Fibrin in Osseous Regeneration After Cystic Enucleation

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.

Study Overview

• Status: Recruiting
• Conditions: Jaw Cysts; Odontogenic Cyst; Osseous Defect After Cyst Enucleation
• Intervention / Treatment: Biological: Autologous Platelet-Rich Fibrin (PRF); Procedure: Conventional Surgical Management

Detailed Description

This study is designed as a randomized controlled clinical trial to evaluate the effectiveness of autologous platelet-rich fibrin (PRF) in enhancing bone regeneration after cystic enucleation in the jaws.

PRF is an autologous biomaterial rich in growth factors that may enhance bone healing and tissue regeneration. Participants undergoing cystic enucleation will be randomly assigned to either a PRF-treated group or a control group receiving conventional treatment without PRF.

Clinical and radiographic assessments will be performed to evaluate bone regeneration, healing rate, and postoperative outcomes. If PRF demonstrates significant improvement in osseous regeneration, it may represent a minimally invasive and cost-effective alternative to traditional bone grafting procedures.

Ethical approval will be obtained from the Ethical Committee of the Faculty of Medicine and Health Sciences, Sana'a University, Yemen.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Yemen
  • Sana'a Governorate
    • Sanaa, Sana'a Governorate, Yemen, 00000
      • Recruiting
      • Faculty of Medicine and Health Sciences - Sana'a University
      • Contact: lamees F Alareeki, BDS; Phone Number: +967772377003; Email: lamis.alarigi@su.edu.ye

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRF Group; Participants undergoing cystic enucleation in the jaws will receive autologous Platelet-Rich Fibrin (PRF) placed into the osseous defect immediately after surgical enucleation.	Biological: Autologous Platelet-Rich Fibrin (PRF); 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.
Active Comparator: Control Group; Participants 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.	Procedure: Conventional Surgical Management; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sana'a University

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2025
• Primary Completion (Estimated): April 19, 2026
• Study Completion (Estimated): October 19, 2026

Study Registration Dates

• First Submitted: February 14, 2026
• First Submitted That Met QC Criteria: February 14, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 14, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; PRF; Oral Surgery; Bone Regeneration; Platelet-Rich Fibrin; Osseous Healing; Cyst Enucleation; Jaw Bone Defect
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Neoplasms; Jaw Diseases; Cysts; Bone Cysts; Odontogenic Cysts; Jaw Cysts
• Other Study ID Numbers: OMFS:01/06/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No