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Comparison Between Socket Shield and Conventional Techniques in Immediate Implant Placement.

2026年8月10日 更新者：Omar Ibrahim Wahedi、Minia University

Comparative Study Between Using Socket Shield And Conventional Techniques In Immediate Implant Placement (A Randomized Clinical Trial)

The goal of this randomized clinical trial is to compare whether immediate implant placement using the socket-shield technique can better preserve bone density, bone level, and peri-implant tissue health compared to conventional immediate implant placement in patients requiring tooth extraction in the maxillary esthetic zone.

This study is conducted in systemically healthy adult patients aged 20-60 years who have non-restorable maxillary anterior teeth indicated for immediate implant placement.

The main questions this study aims to answer are:

Does the socket-shield technique result in better peri-implant bone density and bone level preservation compared to the conventional immediate implant technique?

Does the socket-shield technique lead to improved clinical peri-implant parameters, including probing depth, bleeding on probing, keratinized tissue width, and soft tissue thickness?

participants will be divided into two groups: (both groups will receive immediate implant placement of a tooth requiring extraction in the maxillary esthetic zone.) First group: will recieve immediate implant using conventional technique. second group: will recieve immediate implant using socket shield technique.

Participants will:

  • Undergo clinical and radiographic examinations, including cone beam computed tomography (CBCT).
  • Receive immediate implant placement using either the conventional technique or the socket-shield technique.
  • Be followed up clinically and radiographically for 9 months to assess bone and soft tissue healing.
  • Attend regular postoperative and follow-up visits for evaluation of implant stability and peri-implant tissue health.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

16

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。

学习联系方式

学习地点

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

  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

  • Patients aged between 20 and 60 years of both genders
  • All participants should be systemically healthy, as assessed using the dental modification of the Cornell Medical Index.
  • Gingival and periodontal health to be confirmed according to the criteria outlined in the new classification system proposed by Caton et al. (2018).
  • Presence of non-restorable teeth due to trauma, complicated crowns or root fractures.
  • Presence of extensive destructive caries making the tooth unsalvageable, particularly in esthetic zones.
  • Clinical indication for immediate implant placement, especially in cases where minimizing post-extraction bone resorption and soft tissue collapse is critical.
  • Availability of adequate interocclusal space to accommodate the necessary prosthetic components without occlusal interference.

Exclusion Criteria:

(for socket-shield technique)

  • Pregnant female.
  • Patients with parafunctional habits (e.g., bruxism, clenching).
  • Smokers.
  • Teeth with clinical mobility.
  • Teeth with root fractures extending below the alveolar bone level.
  • Periodontal ligament space widening.
  • Signs of internal or external root resorption.
  • Current or previous periodontal disease

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
有源比较器：GROUP I
Immediate Implant Placement Using Conventional Technique
程序：Conventional Technique
Immediate Implant Placement Using Conventional Technique
实验性的：GROUP II
Immediate Implant Placement Using Socket-Shield Technique
程序：Socket-Shield Technique
Immediate Implant Placement Using Socket-Shield Technique

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
Change in Bone Density Around Immediate Implants.
大体时间：At baseline of implant placement then after 9 months

Assessment of bone mineral density using Gray scale values (GSV) derived from Cone Beam Computed Tomography (CBCT) scans. Measurements will be evaluated at the buccal bone adjacent to the retained root fragment (Socket Shield Group) and adjacent to the implant surface (Conventional Immediate Placement Group). The change will be calculated by subtracting the baseline value from the 9-month follow-up value.

Unit of Measure: Gray scale values Time Frame: Baseline to 9 months post-implant placement

Measure Description:

Bone density measured using average gray values extracted from CBCT DICOM files at the buccal aspect of the implant site. Gray scale values reflect the radiographic attenuation/pixel intensity of the surrounding bone.
At baseline of implant placement then after 9 months
Change in Marginal Bone Level Around Immediate Implants.
大体时间：At baseline of implant placement then after 9 months.
  • Linear measurement of the distance from the implant platform to the first bone-to-implant contact point to assess crestal bone stability.
  • Unit of measure : Millimeters (mm).
At baseline of implant placement then after 9 months.

次要结果测量

结果测量
措施说明
大体时间
Change in Probing Depth (PD)
大体时间：3 months, 6 months, and 9 months post-surgery.

Measurement of the distance from the peri-implant mucosal margin to the bottom of the clinical pocket using a calibrated periodontal probe.

Unit of Measure: Millimeters (mm)
3 months, 6 months, and 9 months post-surgery.
Modified Gingival Index (MGI)
大体时间：3 months, 6 months, and 9 months post-surgery.

Assessment of the visual signs of inflammation of the peri-implant soft tissues. Scores range from 0 to 4 (0 = Normal, 1 = Mild inflammation, 2 = Mild inflammation with color change, 3 = Moderate inflammation, 4 = Severe inflammation).

Unit of Measure: Score on a scale (0-4)
3 months, 6 months, and 9 months post-surgery.
Modified Plaque Index (MPI)
大体时间：3 months, 6 months, and 9 months post-surgery.

Assessment of the amount of plaque on the implant/restoration surface. Scores range from 0 to 3 :

  • 0 = No plaque
  • 1 = Plaque only recognized by running a probe
  • 2 = Plaque visible to the naked eye
  • 3 = Abundance of soft matter).

Unit of Measure: Score on a scale (0-3)
3 months, 6 months, and 9 months post-surgery.
Gingival Thickness (GT)
大体时间：Baseline, 3 months, 6 months, and 9 months post-surgery.

Assessment of the thickness of the peri-implant mucosa. This will be measured using a digital caliper or endodontic file with a rubber stopper 2mm apical to the gingival margin.

Unit of Measure: Millimeters (mm)
Baseline, 3 months, 6 months, and 9 months post-surgery.
Width of Keratinized Tissue (KTW)
大体时间：Baseline, 3 months, 6 months, and 9 months post-surgery.

Measured from the gingival margin to the mucogingival junction at the mid-facial aspect of the implant site.

Unit of Measure: Millimeters (mm)
Baseline, 3 months, 6 months, and 9 months post-surgery.

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。

赞助

Minia 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)

2025年10月20日

初级完成 (估计的)

2026年10月1日

研究完成 (估计的)

2026年11月1日

研究注册日期

首次提交

2025年12月15日

首先提交符合 QC 标准的

2026年8月10日

首次发布 (实际的)

2026年8月12日

研究记录更新

最后更新发布 (实际的)

2026年8月12日

上次提交的符合 QC 标准的更新

2026年8月10日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • MU-EC Research No.1187

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

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