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临床试验/NCT07460648
NCT07460648已完成不适用

"Spontaneous Bone Healing in Two Stage Modified Socket Shield Therapy" Can It Be a Dependable Approach for Delayed Implant Placement? A Randomized Controlled Trial

Mansoura University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
Soft tissue ingrowth dimension: depth

研究概览

简要总结

Modified socket shield therapy (SST) has been proposed to preserve the facial plate and peri implant tissues. Whether spontaneous healing after two stage modified SST provides outcomes comparable to grafted SST before delayed implant placement remains unclear.

详细描述

There remains no consensus regarding management of the space adjacent to the retained shield-whether it should be filled with a biomaterial or left for spontaneous healing. Clinical observations suggest that healing may not always yield complete mineralized fill; instead, a soft tissue interface can develop along the internal aspect of the root fragment, potentially limiting bone formation within the defect. At present, it remains unclear whether placement of a bone substitute can reliably reduce or prevent this soft tissue ingrowth along the inner surface of the retained fragment, providing a rationale for controlled comparisons of grafted and nongrafted two stage SST protocols. Therefore, the present controlled clinical study was designed to compare SST with xenograft combined with MPM augmentation versus SST alone, followed by delayed implant placement after a 6 month healing period. The study evaluated soft tissue ingrowth as key healing outcomes, alongside histologic findings and implant related parameters, including implant stability, as well as the incidence and management of procedure related complications.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

Statistician

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • ASA I (healthy)
  • With intact buccal periodontal tissues
  • No parafunctional habits
  • Good oral hygiene
  • Willingness to comply with the study protocol and follow up schedule

排除标准

  • Acute infection at the extraction site
  • Extensive buccal plate loss
  • Vertical root fracture on the buccal aspect
  • Fracture patterns extending below bone level
  • Internal or external resorption
  • Root caries compromising the shield
  • Excessive tooth mobility
  • Heavy smoking

研究组 & 干预措施

Control Group

Experimental

Socket Shield Technique alone with spontaneous healing

干预措施: Socket Shield Technique (Procedure)

Test Group

Experimental

Socket Shield Technique with MPM augmentation

干预措施: Socket Shield Technique (Procedure)

结局指标

主要结局

Soft tissue ingrowth dimension: depth

时间窗: 6-month (at the time of implant placement)

Soft tissue ingrowth dimensions; depth and width were measured using a calibrated periodontal probe with readings taken to the nearest millimeter and rounded up when the probe reading reached or exceeded the midpoint between millimeter markings. Depth (mm) was recorded from the most coronal aspect of the retained root fragment and measured apically until hard tissue was encountered.

Soft tissue ingrowth dimension: width

时间窗: 6-month (at the time of implant placement)

Width (mm) was measured in a buccopalatal direction from the central aspect of the socket shield to the point where hard tissue was reached, representing the maximum diameter of the soft tissue ingrowth.

次要结局

未报告次要终点

研究者

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

Mai Ahmed Haggag

Assistant Professor

Mansoura University

研究点 (1)

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