Hard and Soft Tissue Outcomes of Vestibular Socket Therapy Using Magnesium Membrane Versus Cortical Lamina in the Esthetic Zone.
2026年9月3日 更新者：Dina Mohamed Hosam Eldin Zaghloul、Mansoura University
Hard and Soft Tissue Outcomes of Vestibular Socket Therapy Using Magnesium Membrane Versus Cortical Lamina for Type II Extraction Sockets in the Esthetic Zone: A Randomized Clinical Trial
This randomized clinical trial aims to compare two membrane materials used in Vestibular Socket Therapy (VST) technique during immediate implant placement in Type II extraction sockets in the esthetic zone.
A total of 30 patients will be randomly allocated to receive VST using either a biodegradable magnesium membrane or a cortical lamina membrane. Both groups will receive immediate implant placement and xenogeneic bone graft.
The study will compare changes in facial bone dimensions, soft tissue volume, implant stability, pink esthetic score, patient satisfaction, surgical time, and postoperative complications over a 6-month follow-up period.
研究概览
地位
尚未招聘
研究类型
介入性
注册 (估计的)
30
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
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Dakahlia Governorate
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Al Mansurah、Dakahlia Governorate、埃及、35511
- Outpatient Clinic of the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Mansoura University
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接触：
- Dina Mohamed Hosam Eldin Zaghloul, Bachelor Of Dental Surgery
- 电话号码：+201000985501
- 邮箱：dinahosam90@gmail.com
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首席研究员：
- Dina Mohamed Hosam Eldin Zaghloul, Bachelor Of Dental Surgery
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副研究员：
- Nahed Ibrahim Ghoneim, PhD in Oral Surgery
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副研究员：
- Ayman Moustafa Yaseen, PhD in Oral Surgery
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副研究员：
- Ammar Taha Kassem, PhD in Prosthodontics
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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:
- Age between 18 and 45 years.
- Requirement for extraction of one or more teeth in the maxillary esthetic zone with Type II extraction sockets.
- Presence of adequate palatal and apical bone to achieve primary implant stability.
- Adequate interocclusal restorative space for implant-supported prosthetic rehabilitation.
- Good oral hygiene and satisfactory plaque control
Exclusion Criteria:
- Acute infection at the intended implant site (e.g., acute abscess or cellulitis).
- Uncontrolled systemic diseases or medical conditions that may compromise bone healing or osseointegration.
- History of irradiation to the head and neck region within one year before implant placement.
- Alcohol or drug abuse.
- Pregnancy or lactation.
- Parafunctional habits such as bruxism or clenching.
- Current smoking or tobacco using.
- Poor oral hygiene or inability to maintain adequate plaque control.
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：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Vestibular Socket Therapy Using Magnesium Membrane
Vestibular Socket Therapy using a biodegradable magnesium membrane in conjunction with immediate implant placement and xenogeneic bone grafting for Type II extraction sockets in the maxillary esthetic zone.
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Vestibular Socket Therapy using a biodegradable magnesium membrane in conjunction with immediate implant placement and xenogeneic bone grafting for Type II extraction sockets in the maxillary esthetic zone.
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有源比较器：Vestibular Socket Therapy Using Cortical Lamina
Vestibular Socket Therapy using a cortical lamina membrane in conjunction with immediate implant placement and xenogeneic bone grafting for Type II extraction sockets in the maxillary esthetic zone.
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Vestibular Socket Therapy using a cortical lamina membrane in conjunction with immediate implant placement and xenogeneic bone grafting for Type II extraction sockets in the maxillary esthetic zone.
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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 |
|---|---|---|
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Facial Bone Dimensional Changes
大体时间：Immediately after surgery (T0) and 6 months (T6)
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CBCT scans obtained immediately after surgery (T0) and at six months (T6) will be superimposed using OnDemand3D software.
The following parameters will be assessed: facial bone thickness at the crestal level, facial bone thickness at the middle level, facial bone thickness at the apical level, and facial bone height.
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Immediately after surgery (T0) and 6 months (T6)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Soft Tissue Volumetric Changes
大体时间：Baseline and 6 months postoperatively
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Assessed by superimposition of intraoral scan STL files obtained at baseline and 6 months postoperatively.
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Baseline and 6 months postoperatively
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Patient-reported Esthetic Satisfaction
大体时间：6 months postoperatively
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Assessed at 6 months using a 100-mm Visual Analog Scale (VAS), where 0 indicates complete dissatisfaction and 100 indicates complete satisfaction with the esthetic result.
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6 months postoperatively
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Surgical Time
大体时间：During the surgical procedure
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Recorded in minutes from the start of the surgical procedure until completion.
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During the surgical procedure
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Postoperative Complications
大体时间：1 week, 1 month, 3 months, and 6 months postoperatively
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Recorded throughout the follow-up period and evaluated at 1 week, 1 month, 3 months, and 6 months postoperatively for the occurrence of membrane exposure, wound dehiscence, infection, graft loss, and implant failure.
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1 week, 1 month, 3 months, and 6 months postoperatively
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Implant Stability
大体时间：Immediately postoperatively, 3, and 6 months postoperatively.
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Assessed using radiofrequency analysis (RFA) using an Osstell Mentor Device.
A SmartPeg will be attached to each implant, and resonance frequency measurements will be recorded in four directions (every 90°).
The obtained values will be expressed as Implant Stability Quotient (ISQ) scores, and the mean ISQ value for each implant will be used for statistical analysis.
The Implant Stability Quotient (ISQ) ranges from 1 to 100, with higher scores indicating greater implant stability.
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Immediately postoperatively, 3, and 6 months postoperatively.
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Pink Esthetic Score (PES)
大体时间：6 months postoperatively.
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The Pink Esthetic Score (PES) assesses peri-implant soft tissue esthetics using seven parameters, each scored from 0 to 2, for a total score of 0-14.
Higher scores indicate better esthetic outcomes.
Assessed using standardized clinical photographs.
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6 months postoperatively.
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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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Pinto A, Mazzetti V, Carosi P, Lorenzi C. Cortical Laminar Bone Membrane in Implant Dentistry: Biological Basis, Clinical Protocols, and Outcomes. Appl Sci. 2025;15(22):12243.
- Elad A, Rider P, Rogge S, Witte F, Tadic D, Kacarevic ZP, Steigmann L. Application of Biodegradable Magnesium Membrane Shield Technique for Immediate Dentoalveolar Bone Regeneration. Biomedicines. 2023 Mar 1;11(3):744. doi: 10.3390/biomedicines11030744.
- Elaskary A, Thabet A, Hussin M, Radi IA. Soft and hard tissue evaluation for vestibular socket therapy of immediately placed implants in infected and non-infected sockets: a 1-year prospective cohort study. BMC Oral Health. 2024 Oct 7;24(1):1190. doi: 10.1186/s12903-024-04905-3.
- ElAskary A, Elfana A, Meabed M, Abd-ElWahab Radi I, Akram M, Fawzy El-Sayed K. Immediate implant placement utilizing vestibular socket therapy versus early implant placement with contour augmentation for rehabilitation of compromised extraction sockets in the esthetic zone: A randomized controlled clinical trial. Clin Implant Dent Relat Res. 2022 Oct;24(5):559-568. doi: 10.1111/cid.13120. Epub 2022 Jul 10.
- Th Elaskary A, Y Gaweesh Y, Maebed MA, Cho SC, El Tantawi M. A Novel Method for Immediate Implant Placement in Defective Fresh Extraction Sites. Int J Oral Maxillofac Implants. 2020 Jul/Aug;35(4):799-807. doi: 10.11607/jomi.8052.
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 (估计的)
2026年9月1日
初级完成 (估计的)
2027年6月1日
研究完成 (估计的)
2027年6月1日
研究注册日期
首次提交
2026年8月29日
首先提交符合 QC 标准的
2026年8月29日
首次发布 (实际的)
2026年9月2日
研究记录更新
最后更新发布 (实际的)
2026年9月8日
上次提交的符合 QC 标准的更新
2026年9月3日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他研究编号
- MS.26.08.271
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
未定
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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