Bone Regeneration Using PRF After Cyst Enucleation

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Биопрепарат 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.
• Процедура 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.

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Yemen · 1 центр

• Faculty of Medicine and Health Sciences - Sana'a University — Sanaa

Идентификаторы

NCT: NCT07424716 · OMFS:01/06/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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