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临床试验/NCT07521514
NCT07521514尚未招募不适用

Clinical and Radiographic Evaluation of Guided Tissue Regeneration Using Autogenous Bone Chips and Concentrated Growth Factors Membranes With Simultaneous Implant Placement. (Case Series)

Cairo University1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2026年4月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
8
试验地点
1
主要终点
tissue biotype

研究概览

简要总结

CGF membranes will be prepared using a swing-lock centrifuge. A full-thickness mucoperiosteal flap will be elevated in a narrow alveolar ridge. Implants will be inserted. Autologous bone chips will be harvested via bone scraping and used for augmentation, CGF membranes will be placed over the grafted area. Suturing of the mucoperiosteal flap. Radiographic evaluation of the bone density and tissue thickness will be performed by CBCT preoperatively, immediate postoperative and after the procedure by 4 months. Clinical evaluation of the tissue thickness using periodontal probe preoperatively, immediate postoperatively and after the procedure by 4 months

详细描述

  • Preoperative cone-beam computed tomography (CBCT) images will be obtained for surgical planning and for later comparison during follow-up evaluations.
  • Clinical evaluation of the tissue thickness using periodontal probe
  • Signed consent from the patient agreeing to the procedure
  • All surgical procedures will be performed by the same oral surgeon, following a standardized protocol to ensure consistency. The surgeries will be conducted in a sterilized dental operatory prepared specifically for oral surgery.
  • Patient preparation will include preoperative instructions and aseptic measures.

Sterile drapes will be placed to minimize contamination.

  • The patient will be prepared for phlebotomy, and a blood sample will be drawn into a sterile 10 mL tube without anticoagulant. The sample will be immediately centrifuged using a CGF-specific centrifuge under the designated CGF settings. To ensure proper balance during centrifugation, each tube will be counterbalanced with another tube containing either blood or water. After centrifugation is complete, the tubes will be removed, and the CGF clot will be carefully extracted. Using a PRF preparation tray, the red blood cell (RBC) layer will be separated from the fibrin matrix. The remaining CGF membrane will be ready for use.
  • Prior to surgery, the patient will rinse with 0.12% chlorhexidine gluconate as an antiseptic mouthwash. A topical anesthetic gel will be applied to the injection site prior to the administration of local anesthesia. Once both subjective and objective signs of anesthesia are confirmed, a mucoperiosteal flap will be elevated in a narrow alveolar ridge.
  • Autologous bone chips will be harvested via bone scraping and used for augmentation.
  • Implants will be inserted.
  • CGF membranes will be placed over the grafted area.
  • Interrupted sutures will be performed. Radiographic evaluation of the bone density and tissue thickness will be performed by CBCT, immediate postoperative and after the procedure by 4 months. Clinical evaluation of the tissue thickness using periodontal probe immediate postoperatively and after the procedure by 4 months.

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

入选标准

  • A medical history that contraindicates oral surgical treatment such as (uncontrolled/untreated diabetes mellitus, immuno-compromised status, radio or chemotherapy of the oral and maxillofacial region, treatment with oral and/or intravenous bisphosphonates).
  • Presence of active or untreated periodontal disease.
  • Vertical root fractures involving the buccal aspect.
  • Tooth /teeth with horizontal fractures below bone level.
  • Tooth /teeth with external or internal resorption.
  • Patients with destructive oral habits such as smoking, chewing tobacco, bruxism,etcetera(Chrcanovic et al., 2014).

排除标准

  • A medical history that contraindicates oral surgical treatment such as (uncontrolled/untreated diabetes mellitus, immuno-compromised status, radio or chemotherapy of the oral and maxillofacial region, treatment with oral and/or intravenous bisphosphonates).
  • Presence of active or untreated periodontal disease.
  • Vertical root fractures involving the buccal aspect.
  • Tooth /teeth with horizontal fractures below bone level.
  • Tooth /teeth with external or internal resorption.
  • Patients with destructive oral habits such as smoking, chewing tobacco, bruxism, etcetera(Chrcanovic et al., 2014).

研究组 & 干预措施

GTR with Autogenous Bone Chips and CGF Membrane

Other

干预措施: concentrated growth factor (CGF) Membrane (Other)

结局指标

主要结局

tissue biotype

时间窗: preoperative, immediate postoperative and 4 months after the procedure

using periodontal probe to measure gingival thickness

次要结局

  • bone density(preoperative, immediately postoperative, and 4 months after the surgery)
  • patient satisfaction(after 4 months from the surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Meis Youssef Moustafa

principle investigator

Cairo University

研究点 (1)

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