Eggshell-Derived Hydroxyapatite With Platelet-Rich Fibrin for Bone Regeneration After Jaw Cyst Removal

November 5, 2026 updated by: Ahmed Nasser Ali Mabkhout

Evaluation of Eggshell-Derived Hydroxyapatite Enhanced With Platelet-Rich Fibrin for Alveolar Bone Regeneration Following Cyst Enucleation

This clinical study aims to evaluate bone healing after the surgical removal of jaw cysts using a bone graft material made from chicken eggshells, with or without platelet-rich fibrin (PRF), a substance prepared from the patient's own blood.

Removal of a jaw cyst can leave an empty space in the surrounding bone. Although this space may heal naturally, bone regeneration can take several months. Hydroxyapatite is a bone-like mineral that may support new bone formation. Combining it with PRF may further improve healing.

This prospective, controlled clinical study is being conducted in Sana'a, Yemen. Participants undergo surgical removal of jaw cysts and receive one of the treatment approaches included in the study. The researchers compare bone healing between treatment groups using clinical examinations and dental imaging, including cone-beam computed tomography (CBCT).

Participants are followed for up to six months after surgery. The study evaluates bone regeneration, postoperative pain, wound healing, and possible complications.

The researchers aim to determine whether eggshell-derived hydroxyapatite combined with PRF improves bone regeneration compared with the other treatments being investigated.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This prospective, controlled, non-randomized interventional clinical study evaluates the clinical and radiographic outcomes of eggshell-derived hydroxyapatite (HA) enhanced with autologous platelet-rich fibrin (PRF) for alveolar bone regeneration following the enucleation of odontogenic jaw cysts.

The study is conducted in Sana'a, Yemen, among adult patients requiring surgical enucleation of jaw cysts associated with residual bone defects.

The investigational bone graft material is synthesized from processed chicken eggshells using a chemical preparation method involving phosphoric acid. The resulting calcium phosphate material undergoes physicochemical characterization and is prepared for clinical application under controlled aseptic conditions.

The clinical study includes three treatment groups. Participants are assigned using a repeating A-B-C allocation sequence rather than random assignment. The study evaluates eggshell-derived HA combined with autologous PRF against the other treatment approaches defined in the clinical protocol.

When PRF is used, venous blood is collected from the participant and centrifuged without anticoagulants to obtain a fibrin-rich preparation. The PRF is combined with the prepared HA material and applied to the residual bone defect after cyst enucleation.

Participants undergo standardized surgical management and postoperative clinical assessment. Clinical evaluations include wound healing, postoperative pain, swelling, infection, wound dehiscence, and other treatment-related complications.

Radiographic assessments include panoramic radiography and cone-beam computed tomography (CBCT). Bone regeneration is evaluated through changes in residual defect dimensions and radiographic healing during postoperative follow-up, including assessments at three and six months.

The primary objective is to compare radiographic bone regeneration following cyst enucleation among the treatment groups. Secondary objectives include evaluating soft tissue healing, postoperative discomfort, and treatment-related complications.

The study hypothesis is that eggshell-derived HA combined with autologous PRF may provide improved bone regeneration compared with the other treatment approaches. The investigation is intended to generate clinical evidence regarding the regenerative performance and safety of the locally prepared bone graft material.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Yemen
      • Sanaa, Yemen
        • Recruiting
        • Faculty of Dentistry, Sana'a University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

**Inclusion Criteria:**

  • Adult patients aged 18 to 60 years.
  • Patients diagnosed with odontogenic jaw cysts requiring surgical enucleation.
  • Patients with residual jawbone defects measuring at least 1.5 cm following cyst enucleation.
  • Patients in good general health or with medically controlled systemic conditions.
  • Patients who provide informed consent to participate in the clinical study and agree to scheduled postoperative follow-up examinations.

**Exclusion Criteria:**

  • Patients with an active infection at the surgical site.
  • Patients with a history of radiation therapy or bisphosphonate use.
  • Patients with systemic bone diseases or immunosuppression.
  • Pregnant or lactating women.
  • Patients with known allergies or intolerance to any materials used in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group A: Eggshell-Derived HA + PRF
Procedure: Eggshell-Derived Hydroxyapatite With Platelet-Rich Fibrin Grafting

Following surgical enucleation of the odontogenic jaw cyst, the residual bone defect is filled with locally prepared eggshell-derived hydroxyapatite combined with autologous platelet-rich fibrin (PRF). The PRF is obtained from the patient's venous blood by centrifugation without anticoagulants. The combined graft is placed into the bone cavity before surgical wound closure.
Active Comparator: Group B: Eggshell-Derived HA Alone
Procedure: Eggshell-Derived Hydroxyapatite Grafting Alone

Following surgical enucleation of the odontogenic jaw cyst, the residual bone defect is filled with eggshell-derived hydroxyapatite without platelet-rich fibrin. The graft is placed directly into the bone cavity before surgical wound closure.
No Intervention: Group C: Spontaneous Bone Healing

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Alveolar Bone Defect Dimensions Following Cyst Enucleation
Time Frame: Baseline and 3 and 6 months after surgery

Radiographic bone regeneration is assessed by measuring changes in the vertical and horizontal dimensions of the residual bone defect in millimeters using cone-beam computed tomography (CBCT). Measurements obtained at baseline are compared with those at 3 and 6 months after surgery to evaluate bone defect reduction among the treatment groups.
Baseline and 3 and 6 months after surgery
Change in Radiographic Density Within the Healing Bone Defect
Time Frame: Baseline and 3 and 6 months after surgery

Changes in radiographic density within the bone defect are evaluated using CBCT image gray values obtained from a defined region of interest. Measurements are compared between baseline and follow-up examinations at 3 and 6 months, using a consistent imaging and measurement protocol. Gray values are reported as relative radiographic measurements rather than calibrated Hounsfield units.
Baseline and 3 and 6 months after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postoperative Pain Intensity
Time Frame: 1 week, 1 month, 3 months, and 6 months after surgery

Postoperative pain is assessed using a patient-reported visual analog scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain). Pain scores are recorded during postoperative follow-up visits and compared among the treatment groups.
1 week, 1 month, 3 months, and 6 months after surgery
Clinical Soft Tissue Healing
Time Frame: 1 week, 1 month, 3 months, and 6 months after surgery

Healing of the surgical site is assessed clinically by examining mucosal wound closure and recording the presence or absence of swelling and wound dehiscence during postoperative follow-up visits.
1 week, 1 month, 3 months, and 6 months after surgery
Incidence of Postoperative Complications
Time Frame: From surgery through 6 months of postoperative follow-up

The number of participants experiencing postoperative complications, including surgical-site infection, wound dehiscence, or other documented procedure-related complications, is recorded and compared among the treatment groups.
From surgery through 6 months of postoperative follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ahmed Nasser Ali Mabkhout

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 14, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 08/09/2O25:OMFS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared with external researchers. Participant-level clinical and radiographic data will be kept confidential in accordance with the approved study protocol, institutional ethical requirements, and applicable data protection regulations. Aggregated and anonymized study results may be reported in scientific publications.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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