Clinical and Radiographic Evaluation of The Use of CGF Plugs Packed in Fresh Odontectomy Site of Impacted Lower 3rd Molars (Case Series Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 主要终点
- Bone Density
研究概览
简要总结
The goal of this clinical trial is to learn if Concentrated Growth Factor (CGF) plugs help improve bone healing and reduce pain after the surgical removal of impacted lower third molars.
The study aims to answer the following:
Does packing CGF plugs into the extraction site improve bone density? Does the use of CGF plugs reduce postoperative pain for the patient?
Researchers will evaluate the healing outcomes of patients receiving this treatment in a prospective case series study. Because this is a case series, all participants will receive the CGF plug intervention rather than being compared to a placebo group.
Participants in this study will:
Undergo a blood draw to create the autologous CGF plug from their own growth factors.
Undergo the surgical extraction of an impacted lower third molar under local anesthesia.
Have a CGF plug placed in the extraction socket immediately following the tooth removal.
Report their pain levels using a numeric scale on Day 1, Day 3, and Day 7 after surgery.
Return for a follow-up CBCT scan three months after the procedure to evaluate bone density changes.
详细描述
The surgical removal of impacted lower third molars, commonly known as wisdom teeth, is one of the most frequent procedures in oral surgery. While routine, this procedure often leads to significant postoperative challenges, including pain and substantial bone loss in the extraction area. This bone loss can compromise the health of the adjacent teeth and the surrounding periodontal tissue.
To improve healing outcomes, this study investigates the use of Concentrated Growth Factor (CGF). CGF is a third-generation autologous platelet concentrate-meaning it is derived from the patient's own blood. Unlike earlier versions like PRP or PRF, CGF is created using a specialized variable-speed centrifugation process that results in a denser fibrin matrix. This matrix is rich in growth factors and regenerative cells, which may offer superior mechanical properties and a more sustained release of healing factors to promote bone regeneration and reduce pain.
The researchers aims to evaluate the clinical and radiographic effectiveness of using CGF in a "plug" form. The CGF plug is valued for its stability and ease of handling within the surgical site. The study specifically looks at:
Bone Density Improvement: Measuring how well the extraction site fills with new bone over three months.
Pain Management: Assessing whether the biological properties of CGF can lower the intensity of pain experienced by patients in the week following surgery.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Both sexes. Patients requiring odontectomy of impacted lower 3rd molar.
排除标准
- •- Patients who are pre-surgically symptomatic. Use of medications that affect bleeding time or bone remodeling. Patients with a history of radiotherapy/chemotherapy. Patients who are pregnant, lactating, or on oral contraceptives. Patients having acute/chronic infections or any kind of pathology (evaluated and confirmed radiographically).
结局指标
主要结局
Bone Density
时间窗: A Cone-beam computed tomography (CBCT) scan is taken immediately after the surgical procedure to document the initial state of the extraction site packed with the CGF plug. Final Assessment: A follow-up CBCT scan is performed 3 months post-operatively.
The study measures the changes in density within the alveolar bone. It is evaluated using Cone-Beam Computed Tomography (CBCT), which provides 3D imaging of the surgical site. The density is quantified using Hounsfield units, a standardized scale for describing radiodensity in CT scans. An initial scan is taken immediately after surgery to establish a baseline of the empty socket packed with the CGF plug. A follow-up scan is taken 3 months post-operatively to measure the new bone formation.
Post Operative Pain
时间窗: The time frame for the secondary outcome of Postoperative Pain consists of three specific measurement points during the first week after surgery: 1 day post-operatively 3 days post-operatively 7 days post-operatively
This outcome measures the intensity of subjective pain experienced by the participant following the surgical extraction of the impacted third molar. Pain is assessed using the Verbal Numeric Rating Scale (VNRS). This is a validated tool where the investigator asks the patient to rate their pain level. The score is recorded as a numerical value on a scale from 0 to 10, where 0 represents "no pain" and 10 represents the "worst imaginable pain".
次要结局
未报告次要终点
研究者
MESHARI MOHAMMED ALHARBI
Principal Investigator
Cairo University