Jaw Cysts, Odontogenic Cyst, Osseous Defect After Cyst Enucleation
Conditions
Keywords
Platelet-Rich Fibrin, PRF, Cyst Enucleation, Bone Regeneration, Randomized Controlled Trial, Oral Surgery, Osseous Healing, Jaw Bone Defect
Brief summary
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
BIOLOGICALAutologous 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.
PROCEDUREConventional 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.
Sponsors
Sana'a University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label study. Participants, care providers, and investigators are aware of the assigned intervention (PRF or control). No masking is used.
Intervention model description
Participants will be randomly allocated into two parallel groups. The intervention group will receive autologous platelet-rich fibrin (PRF) following cystic enucleation. The control group will undergo cystic enucleation without PRF application (standard management). Outcomes related to bone regeneration will be assessed and compared between the two groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic bone regeneration in cystic defects following enucleation | 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. |
Countries
Yemen
Outcome results
None listed