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NCT Number: NCT07424716

Bone Regeneration Using PRF After Cyst 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine and Health Sciences - Sana'a University

Sanaa, Sanaa Governorate, 00000, Yemen

Location status: Recruiting

Location contact

lamees F Alareeki, BDS

CONTACT

[email protected]

+967772377003

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Autologous Platelet-Rich Fibrin (PRF)

Biological

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 Surgical Management

Procedure

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 outcomes

  1. Radiographic bone regeneration in cystic defects following enucleation

    Time frame: 6 months after surgery

    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.

Sponsors and collaborators

Lead sponsor

Sana'a University

Other

Registry information

Official study title

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

Acronym: PRF-Bone

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2026
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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