Odontogenic CystPRF-BoneNCT07424716
Bone Regeneration Using PRF After Cyst Enucleation
A study testing Autologous Platelet-Rich Fibrin (PRF) and Conventional Surgical Management in people with Odontogenic Cyst and Jaw Cysts, run by Sana'a University at 1 site in Yemen.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Odontogenic Cyst, Jaw Cysts, Osseous Defect After Cyst Enucleation
- What is being tested?
- Autologous Platelet-Rich Fibrin (PRF) and Conventional Surgical Management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteYemen
- Study dates
- 19 May 2025to 19 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yemen1 site, 1 recruiting
- Recruiting
Faculty of Medicine and Health Sciences - Sana'a University
Sanaa, Sanaa Governorate, 00000
lamees F Alareeki, BDS, +967772377003, lamis.alarigi@su.edu.ye
About this study
Official title: Clinical Efficacy of Platelet-Rich Fibrin in Osseous Regeneration After Cystic 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.
Read the 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.
- Being tested
- Autologous Platelet-Rich Fibrin (PRF), Conventional Surgical Management
- Keywords
- Platelet-Rich Fibrin, PRF, Cyst Enucleation, Bone Regeneration, Randomized Controlled Trial, Oral Surgery, Osseous Healing, Jaw Bone Defect
- Medical subject headings
- Odontogenic Cysts, Jaw Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 ManagementProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| PRF Group | Experimental | Participants undergoing cystic enucleation in the jaws will receive autologous Platelet-Rich Fibrin (PRF) placed into the osseous defect immediately after surgical enucleation. Receives: Biological: Autologous Platelet-Rich Fibrin (PRF) |
| Control Group | Active comparator | 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. Receives: Procedure: Conventional Surgical Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start19 May 2025
- Primary completion19 Apr 2026 (estimated)
- Study completion19 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Odontogenic CystStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sana'a University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lamees Fozi Alareeki, Sana'a University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07424716
- Sponsor's protocol ID
- OMFS:01/06/2025
- Acronym
- PRF-Bone
- Status last verified
- Feb 2026
- First submitted
- 14 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Platelet-Rich Fibrin in Osseous Regeneration After Cystic Enucleation
- ClinicalTrials.gov ID
- NCT07424716
- Acronym / sponsor ID
- PRF-Bone / OMFS:01/06/2025
- Keywords
- Platelet-Rich Fibrin, PRF, Cyst Enucleation, Bone Regeneration, Randomized Controlled Trial, Oral Surgery, Osseous Healing, Jaw Bone Defect
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sana'a UniversityUniversity, hospital or other
- Study start
- 19 May 2025 (actual)
- Primary completion
- 19 Apr 2026 (estimated)
- Study completion
- 19 Oct 2026 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| PRF Group | Experimental | Biological: Autologous Platelet-Rich Fibrin (PRF)Participants undergoing cystic enucleation in the jaws will receive autologous Platelet-Rich Fibrin (PRF) placed into the osseous defect immediately after surgical enucleation. |
| Control Group | Active comparator | Procedure: Conventional Surgical ManagementParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | PRF Group |
| Conventional Surgical ManagementConventional 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. | Procedure or surgery | Control Group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Faculty of Medicine and Health Sciences - Sana'a University
Sanaa, Yemen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Platelet-Rich Fibrin (PRF) and Conventional Surgical Management in people with Odontogenic Cyst and Jaw Cysts, run by Sana'a University at 1 site in Yemen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Yemen. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic bone regeneration in cystic defects following enucleation (time frame: 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.