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美学区即刻种植与即刻修复中牙槽窝盾技术对比早期种植的种植体周围软硬组织变化

2026年10月31日 更新者:Gulf Medical University

美学区即刻种植结合牙槽嵴盾技术与即刻修复与早期II型种植的种植体周围软硬组织变化评估——一项随机对照临床试验

This randomized controlled clinical trial aims to compare peri-implant hard and soft tissue dimensional changes following immediate implant placement with the socket shield technique and immediate restoration versus early type II implant placement with contour graft in the esthetic zone. The primary outcome is the Pink Esthetic Score (PES), while secondary outcomes include mid-facial mucosal recession, radiographic vertical and horizontal buccal bone remodeling, and patient satisfaction after 12 months.

研究概览

详细说明

Immediate implant placement is widely used for replacing non-restorable teeth in the esthetic zone. However, post-extraction remodeling of the buccal bone plate can lead to soft tissue recession and compromised esthetic outcomes. The socket shield technique has been proposed as a partial extraction therapy designed to preserve the buccal root fragment and maintain the facial bone and gingival architecture.

This single-center, prospective randomized controlled clinical trial aims to evaluate the effectiveness of the socket shield technique with immediate implant placement and immediate restoration compared with early type II implant placement with contour augmentation.

Forty-two patients requiring extraction of a single non-restorable tooth in the esthetic zone will be randomly allocated into two groups:

Test group: Immediate implant placement with socket shield technique and immediate restoration.

Control group: Early implant placement following soft tissue healing with contour augmentation.

Clinical, radiographic, and patient-reported outcomes will be assessed over a 12-month follow-up period.

研究类型

介入性

注册 (实际的)

56

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

    • Ajman Emirate
      • Ajman、Ajman Emirate、阿拉伯联合酋长国、4184
        • Gulf Medical University

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 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Adults aged 18 years or older
  2. Patients presenting with a single non-restorable tooth in the esthetic zone indicated for extraction and implant replacement
  3. Presence of a thin buccal bone plate (<1 mm)
  4. Adequate bone volume to allow implant placement in a prosthetically ideal position
  5. Intact socket walls following tooth extraction
  6. Ability to achieve primary implant stability ≥35 Ncm at the time of implant placement
  7. Patients willing to participate in the study and able to provide written informed consent

Exclusion Criteria:

  1. History of systemic diseases that may affect bone healing
  2. Use of medications that may influence bone metabolism (e.g., bisphosphonates)
  3. Smoking within the past 5 years
  4. Presence of acute infection at the surgical site or adjacent teeth
  5. Teeth with vertical or subcrestal horizontal root fractures on the buccal aspect
  6. Presence of internal or external root resorption
  7. Severe periodontal destruction at the implant site

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:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Immediate Implant Placement and Immediate Restoration with the Socket Shield Tech

Participants allocated to this experimental group will undergo immediate implant placement following partial extraction therapy using the socket shield technique. After decoronation and preparation of the buccal root fragment, the implant osteotomy will be created palatal to the retained root fragment to achieve correct prosthetic positioning. The gap between the implant and the root fragment will be filled with deproteinized bovine bone mineral, and an immediate provisional restoration will be placed using a PMMA temporary crown. Final implant-supported restoration will be delivered after approximately 3 months. Participants will be followed for 12 months to evaluate peri-implant hard and soft tissue changes and esthetic outcomes.

mmediate implant placement following partial extraction therapy using the socket shield technique. After decoronation and preparation of the buccal root fragment, the implant osteotomy will be created palatal to the retained root fragment to achieve correct prosthetic positioning. The gap between the implant and the root fragment will be filled with deproteinized bovine bone mineral, and an immediate provisional restoration will be placed using a PMMA temporary crown. Final implant-supported restoration will be delivered after approximately 3 months

其他名称:
  • 部分提取疗法
有源比较器:Early Type II Implant placement with Contour augmentation with Xenograft

Participants assigned to this active comparator group will undergo atraumatic extraction of the non-restorable tooth followed by early type II implant placement after a healing period of approximately 4-8 weeks. During implant surgery, a full-thickness flap will be elevated and the implant will be placed in the ideal prosthetic position. Contour augmentation will be performed using autogenous bone chips and deproteinized bovine bone mineral particles, which will be covered with a collagen membrane. After approximately 3 months of healing, the implant will be restored with a definitive implant-supported prosthetic restoration. Participants will be followed for 12 months to assess peri-implant hard and soft tissue changes and esthetic outcomes.

atraumatic extraction of the non-restorable tooth followed by early type II implant placement after a healing period of approximately 4-8 weeks. During implant surgery, a full-thickness flap will be elevated and the implant will be placed in the ideal prosthetic position. Contour augmentation will be performed using autogenous bone chips and deproteinized bovine bone mineral particles, which will be covered with a collagen membrane. After approximately 3 months of healing, the implant will be restored with a definitive implant-supported prosthetic restoration

其他名称:
  • II型种植体植入

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
Pink Esthetic Score (PES)
大体时间:12 months after implant restoration

Evaluation of peri-implant soft tissue esthetic outcome using the Pink Esthetic Score, which assesses seven parameters including mesial papilla, distal papilla, soft tissue level, soft tissue contour, alveolar process deficiency, soft tissue color, and texture around the implant restoration. Each parameter is scored from 0 to 2, with a maximum score of 14 indicating optimal esthetic outcome.

12 months after implant restoration

次要结果测量

结果测量
措施说明
大体时间
Peri-implant Mid-facial Mucosal Recession
大体时间:12 months after implant placement

Measurement of vertical changes in the mid-facial peri-implant mucosal level. Digital intraoral scans obtained at baseline and during follow-up will be superimposed using digital analysis software to quantify the vertical displacement of the facial mucosal zenith relative to the baseline position.

12 months after implant placement
Horizontal Radiographic Peri-implant Bone Changes
大体时间:12 months after implant Restoration

Assessment of horizontal dimensional changes of the buccal peri-implant bone using cone beam computed tomography (CBCT). The horizontal distance between the implant surface and the outer surface of the buccal bone plate will be measured at the mid-buccal aspect 1 mm apical to the buccal bone crest. Measurements obtained immediately after implant placement will be compared with those obtained at follow-up to determine peri-implant bone remodeling.

12 months after implant Restoration
Vertical Radiographic Peri-implant Bone Changes
大体时间:12 months after implant Restoration

Assessment of vertical dimensional changes of the buccal peri-implant bone using cone beam computed tomography (CBCT). The vertical distance between the implant platform and the buccal alveolar crest at the mid-buccal aspect of the implant will be measured. Measurements obtained immediately after implant placement will be compared with those obtained at follow-up to determine vertical peri-implant bone remodeling.

12 months after implant Restoration
Patient Satisfaction
大体时间:12 months after implant restoration

Patient-reported satisfaction with the implant treatment will be assessed using a Visual Analog Scale (VAS) questionnaire evaluating esthetics and functional outcomes of the implant-supported restoration. The VAS ranges from 0 to 10, where higher scores indicate greater patient satisfaction.

12 months after implant restoration

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。

调查人员

  • 学习椅:Mohamed Atef Sayed, Ph.D.、Assistant Professor of Periodontics
  • 首席研究员:Moheb Silwadi, M.D.S、Gulf Medical University

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3月30日

初级完成 (实际的)

2026年9月1日

研究完成 (实际的)

2026年9月1日

研究注册日期

首次提交

2026年3月9日

首先提交符合 QC 标准的

2026年3月9日

首次发布 (实际的)

2026年3月13日

研究记录更新

最后更新发布 (实际的)

2026年11月3日

上次提交的符合 QC 标准的更新

2026年10月31日

最后验证

2026年10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

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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