An interventional study of Autologous Platelet-Rich Fibrin (PRF) and Conventional Surgical Management in Odontogenic Cyst, Jaw Cysts and Osseous Defect After Cyst Enucleation, sponsored by Sana'a University. Recruiting at 1 site in Yemen. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-20.
Sponsored by Sana'a University · Not applicable, Interventional, and Treatment
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.
Sana'a University is the lead sponsor of 27 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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
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.
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.
Time frame: 6 months after surgery
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report, 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.
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Odontogenic Cysts
Sana'a University