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临床试验/NCT04559802
NCT04559802已完成不适用

Submerged Versus Non-Submerged Healing of Implants Subjected to Contour Augmentation.

Nova Southeastern University2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2020年10月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
2
主要终点
Hard tissue healing around dental implants

研究概览

简要总结

It is a randomized controlled trial to evaluate two surgical techniques for dental implant placement simultaneously with bone augmentation.

详细描述

Implants receiving Contour Augmentations at the time of placement are randomized into two groups, submerged and non submerged. Healing is evaluated at 4 months post op compared to the day of surgery.

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
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age more than 21 years - ASA I or II.
  • Patient's willingness to participate in this study.
  • Availability for 4-month follow-up.
  • Absence of active periodontal disease.
  • Single tooth replacement is needed with simultaneous contour augmentation.
  • Available pre-operative CBCT study.
  • Extraction of tooth at least 8 weeks prior to planned implant therapy.

排除标准

  • Pregnancy at the screening visit.
  • Smoking more than 10 cig/day.
  • Active infection at the site of surgery (teeth involved).
  • Multiple missing teeth adjacent to each other (long span edentulous area).
  • Vertical bone defect less than 2mm (intra surgical assessment)

结局指标

主要结局

Hard tissue healing around dental implants

时间窗: 4 months

bone healing around Submerged and Non-submerged dental implants will be measured by Periodontal probe and radiographs. A Mann-Whitney U Test will be used to calculate bone healing changes. To evaluate bone healing Mean values, standard deviations and frequencies will be calculated.

次要结局

  • Soft tissue healing around dental implants(4 months)

研究者

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

Theofilos Koutouzis

Principal Investigator

Nova Southeastern University

研究点 (2)

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