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临床试验/NCT05194826
NCT05194826Unknown不适用

Vestibular Socket Therapy Using Fascia Lata Membrane Versus Connective Tissue Graft in Immediate Implants of Aesthetic Zone

Hams Hamed Abdelrahman1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
1
主要终点
Chaneg in height of labial (facial) plate of bone

研究概览

简要总结

The aim of this study is to evaluate and compare the Vestibular Socket Therapy (VST) technique using fascia lata membrane versus connective tissue graft both with xenogenic lamina membrane in immediate implants of anterior aesthetic zone.

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

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Class II socket according to Elian et al, described as facial soft tissue is present but the buccal plate is partially missing following extraction of the tooth in the maxillary anterior region.
  • Thin gingival phenotype.
  • Bone quality ranges from D2-D3 as gained from preoperative cone-beam computed tomography.
  • Presence of at least 3 mm of keratinized gingiva.
  • Optimal compliance as evidenced by no missing treatment appointments and a positive attitude towards oral hygiene

排除标准

  • Medically compromised patients and systemic conditions precluding implant and periodontal surgery.
  • Smokers, diabetics, pregnant or lactating women.
  • History of chemotherapy, radiotherapy in head and/or neck region.
  • Bisphosphonate therapy.

结局指标

主要结局

Chaneg in height of labial (facial) plate of bone

时间窗: at baseline, 6 months and 12 months

Cone beam computed tomography (CBCT)

Chaneg in thickness of labial (facial) plate of bone

时间窗: at baseline, 6 months and 12 months

Cone beam computed tomography (CBCT)

Changes in peri-implant mucosal level

时间窗: at baseline, 6 months and 12 months

The changes in peri-implant mucosal level will be assessed by superimposition of scanning files of different intervals to monitor the changes in surface area calculated by software.

Changes in gingival phenotype

时间窗: at baseline, 6 months and 12 months

The changes in gingival phenotype could be assessed at 6 months and 12 months intervals by superimposition of DICOM files on CBCT software.

次要结局

未报告次要终点

研究者

发起方
Hams Hamed Abdelrahman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Alexandria University

研究点 (1)

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