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Recruiting NCT07424716

Bone Regeneration Using PRF After Cyst Enucleation

No phase Interventional Odontogenic Cyst Jaw Cysts Osseous Defect After Cyst Enucleation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Autologous Platelet-Rich Fibrin (PRF), Conventional Surgical Management.
Who it may be relevant to
Registry conditions: Odontogenic Cyst, Jaw Cysts, Osseous Defect After Cyst Enucleation. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Yemen
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Radiographic bone regeneration in cystic defects following enucleation [Time frame: 6 months after surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Yemen · 1 center
  • Faculty of Medicine and Health Sciences - Sana'a University — Sanaa

Identifiers

NCT: NCT07424716 · OMFS:01/06/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗