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.

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.

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.

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.

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 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.

This is an open-label study. Participants, care providers, and investigators are aware of the assigned intervention (PRF or control). No masking is used.