Clinical and Radiographic Evaluation of the Use of CGF Plugs Packed in Fresh Odontectomy Socket (Case Series Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Bone Density
研究概览
简要总结
This study evaluates the use of Concentrated Growth Factor (CGF) plugs-a third-generation healing material made from the patient's own blood-to improve recovery after simple tooth extractions. CGF contains a dense matrix of growth factors and regenerative cells designed to enhance wound healing and tissue regeneration.
Participants requiring a single, non-surgical tooth extraction will have a CGF plug placed into the empty socket immediately following the procedure. The researchers will then monitor two main factors:
- Post-operative Pain: Patients will record their pain levels on a scale of 0 to 10 at 1, 3, and 7 days after the extraction.
- Bone Density: Using specialized imaging (CBCT), the researchers will measure how well the bone heals and fills the socket immediately after the procedure and again at 3 months.
The goal of this research is to determine if CGF plugs can effectively reduce patient discomfort and help preserve bone density, which is critical for future dental treatments like implants.
详细描述
Study Design and Setting This study is a prospective case series conducted in a minor surgery setting. The trial evaluates the clinical and radiographic outcomes of using Concentrated Growth Factor (CGF) plugs in fresh extraction sockets following simple, non-surgical tooth extractions.
Intervention and CGF Preparation
The surgical intervention follows a standardized protocol:
- Preoperative Phase: Patients provide written informed consent. They perform a 0.12% chlorhexidine gluconate mouth rinse and receive baseline imaging via Cone-beam computed tomography (CBCT) for extraction site evaluation.
- CGF Preparation: 10 mL of blood is drawn into a sterile tube without anticoagulants. This is centrifuged using a CGF-specific machine. The CGF clot is separated from the red blood cells, placed in a plug mold, and compressed into a stable plug using a PRF tray.
- Surgical Procedure: Under local anesthesia, an atraumatic extraction is performed using forceps and elevators to avoid damage to socket walls. The socket is curetted to remove granulation tissue and tooth fragments, then irrigated with sterile saline. The CGF plug is inserted into the socket, which is then sutured using Vicryl.
Outcome Assessment
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systemically healthy patients (ASA I or II)
- •Age between 20 and 50 years
- •Require simple, non-surgical extraction of a single tooth
- •Presence of periapical radiolucency at the extraction site
- •Willingness to comply with follow-up and provide signed informed consent
排除标准
- •• Systemic diseases (e.g., uncontrolled diabetes, bone metabolic disorders)
- •History of radiotherapy or chemotherapy
- •Use of medications affecting bone metabolism (e.g., bisphosphonates, chronic steroids)
- •Heavy smokers
- •Pregnant or lactating women
- •Poor oral hygiene or active acute infection/suppuration at the site
研究组 & 干预措施
CGF Plug Intervention Group
This arm involves patients requiring simple, non-surgical extraction of a single tooth. Following an atraumatic extraction and socket curettage, a Concentrated Growth Factor (CGF) plug is packed into the fresh odontectomy site. The CGF plug is prepared by centrifuging 10 mL of the patient's own blood using a specialized variable-speed protocol to create a dense fibrin matrix. After the plug is inserted, the wound is secured with Vicryl sutures. Participants in this arm are evaluated for changes in bone density via CBCT imaging and for postoperative pain using the Verbal Numeric Rating Scale (VNRS).
干预措施: Concentrated Growth Factor (CGF) Plug (Other)
结局指标
主要结局
Bone Density
时间窗: Baseline assessment is conducted immediately after the tooth extraction and CGF plug placement, with a follow-up assessment performed at 3 months postoperatively.
Evaluation of the extraction socket using Cone-beam computed tomography (CBCT) to assess changes in bone healing and preservation. Measurements are specifically analyzed and recorded using the Hounsfield unit scale to quantify mineral density within the site.
Post Operative Pain
时间窗: Assessments are conducted at three specific intervals: Day 1, Day 3, and Day 7 following the surgical procedure.
Clinical evaluation of pain using the Verbal Numeric Rating Scale (VNRS), where participants rate their pain on a scale from 0 to 10 (0 = No pain, 10 = Worst imaginable pain).
次要结局
未报告次要终点
研究者
Aziz Taysir Haydar
Principal Investigator
Cairo University