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临床试验/NCT07520513
NCT07520513尚未招募不适用

Clinical and Radiographic Evaluation of Bone Grafting Using Concentrated Growth Factors and Xenograft With Simultaneous Immediate Implant Placement in Socket Shield Technique

Cairo University1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2026年4月5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
7
试验地点
1
主要终点
crestal bone level

研究概览

简要总结

This prospective case series aims to evaluate the clinical and radiographic outcomes of immediate implant placement using the socket shield technique combined with concentrated growth factors (CGF) and xenograft in the esthetic zone. The study will assess crestal bone level changes and implant stability over a 6-month follow-up period.

详细描述

This study is designed as a prospective case series to evaluate the effectiveness of combining concentrated growth factors (CGF) and xenograft with the socket shield technique (SST) during immediate implant placement in the maxillary esthetic region.

Post-extraction alveolar ridge resorption, particularly of the buccal bone plate, represents a significant challenge in achieving optimal esthetic outcomes. The socket shield technique has been introduced to preserve the buccal bone by retaining the labial portion of the root, thereby minimizing post-extraction resorption. However, immediate implant placement is often associated with the presence of a gap between the implant surface and the socket wall, known as the "jumping gap," which may compromise implant stability and osseointegration.

To enhance bone regeneration within this gap, bone grafting materials are commonly utilized. Concentrated growth factors (CGF), an autologous platelet concentrate, have demonstrated the ability to promote angiogenesis, osteogenesis, and soft tissue healing through the sustained release of growth factors. When combined with xenograft, which provides an osteoconductive scaffold, this approach may improve bone regeneration and implant integration.

In this study, eligible patients requiring immediate implant placement in the esthetic zone will undergo partial extraction therapy using the socket shield technique. Implants will be placed immediately after extraction, and CGF will be prepared from the patient's venous blood and mixed with xenograft to form a "sticky bone" graft, which will be applied to fill the jumping gap.

Radiographic evaluation will be performed using cone-beam computed tomography (CBCT) at 2 weeks and 6 months postoperatively to assess crestal bone level changes. Implant stability will be measured using resonance frequency analysis (Osstell device) and expressed as implant stability quotient (ISQ) values.

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

  • Age ≥18 years old. (Younis, W., & El-Rashidy, A. 2020).
  • Both male and female patients.
  • Maxillary, anterior and premolar segments.

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.

研究组 & 干预措施

Socket Shield Technique with CGF and Xenograft in Immediate Implant Placement

Experimental

Participants will undergo immediate implant placement in the esthetic zone using the socket shield technique. Following partial extraction therapy, implants will be placed immediately, and the jumping gap will be filled using a combination of concentrated growth factors (CGF) and xenograft prepared as "sticky bone." Clinical and radiographic follow-up will be conducted over a 6-month period to evaluate crestal bone levels and implant stability.

干预措施: Socket Shield Technique with Immediate Implant Placement and CGF + Xenograft (Procedure)

结局指标

主要结局

crestal bone level

时间窗: 2 weeks, and 6 months postoperatively

Evaluation of changes in crestal bone level around the dental implant using cone-beam computed tomography (CBCT). Measurements will be taken from a fixed reference point on the implant to the first bone-to-implant contact recorded in millimeters (mm)

次要结局

  • Implant Stability (ISQ Values)(Immediate postoperative, and at 6 months)

研究者

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

Huda Ayman Alrifai

Principal Investigator

Cairo University

研究点 (1)

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