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

2026年11月5日 更新者: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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

30

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Sanaa、也门
        • 招聘中
        • Faculty of Dentistry, Sana'a University
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 60年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

**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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Group A: Eggshell-Derived HA + PRF

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.

有源比较器:Group B: Eggshell-Derived HA 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.

无干预:Group C: Spontaneous Bone Healing

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Alveolar Bone Defect Dimensions Following Cyst Enucleation
大体时间: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
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Postoperative Pain Intensity
大体时间: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
大体时间: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
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年9月14日

初级完成 (估计的)

2027年12月30日

研究完成 (估计的)

2027年12月30日

研究注册日期

首次提交

2026年11月5日

首先提交符合 QC 标准的

2026年11月5日

首次发布 (实际的)

2026年11月12日

研究记录更新

最后更新发布 (实际的)

2026年11月12日

上次提交的符合 QC 标准的更新

2026年11月5日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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