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临床试验/NCT04027660
NCT04027660Unknown不适用

Volumetric (Hard and Soft Tissue) Alterations in Immediate Zirconia Implants

Implantology Institute1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年1月26日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
10
试验地点
1
主要终点
Ridge dimensions (Bone and soft tissue from buccal to palatal) Changes from final impression (Day 2 ) to 2 month after osseointegration (Day 3), in Zirconia Immediate Implants

研究概览

简要总结

The aim is to study bone and soft tissue response to zirconia immediate implants.Volumetric changes will be measured before tooth extraction and after final crow placement.

详细描述

Bone remodeling around immediate implants is a reality in clinical and literature arena. much is known about titanium implants but little in zirconia implants

In patients that require a tooth extraction anywhere in the oral cavity except 3rd molars are candidates fo the study. Once clinical conditions are establish and medical clearance is ok, the decision for an immediate implant is taken.

Patient will undergo for an intraoral Scanner (IOS, Trios 3Shape) to get an STL file of the previous situation.

On the day of surgery an atraumatically tooth extraction is performed (without rasing a flap) and a Zirconia implant is inserted on the alveolar socket.

The jumping gap (distance from crystal bone to implant body will be filled with a zenograft type of biomaterial) no sutures or membrane will be used.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Patients with a non-restorable tooth schedule for extraction
  • Anywhere on the mouth except 3rd molar teeth
  • Tooth site with no active infection
  • No loss of the buccal, palatal or inter proximal bone
  • If chronical apical pathology, the six should be less that 4 mm diameter
  • ASA 1 or ASA 2 Patient
  • Sings the Informed consent -

排除标准

  • Site has an active infection
  • Periapical lesion Beyond 5 mm
  • Bone resorption of buccal, palatal or inter proximal plate beyond 2 mm
  • Patient doesn't want an immediate implant
  • Patient doesn't want a Zirconia Implant
  • ASA 3 or ASA 4 Patient
  • Refuse to Sign informed consent -

结局指标

主要结局

Ridge dimensions (Bone and soft tissue from buccal to palatal) Changes from final impression (Day 2 ) to 2 month after osseointegration (Day 3), in Zirconia Immediate Implants

时间窗: 1Year

Physiologic resorption rate from Day 2 - Day of final Impression to Day 3- 3 month after final crown insertion measured by STL superimposition. Acquisition of STL File with an IOS in both time frames, and in an STL reader software (Geomagic Control X) we merge them with the corresponding common landmarks for a best fit alignment. Measure include, Total bone and soft tissue volume loss (in cubic centimeters). Bone collapse measured in mm from the most buccal point to most palatal point of the ridge.

Ridge dimensions (Bone and soft tissue from buccal to palatal) Changes from Implant placement in alveolar extraction sockets (Day 1) to 2 month after osseointegration (Day 3), in Zirconia Immediate Implants

时间窗: 1year

Physiologic resorption rate from Day 1 - implant placement to Day 3- 3 month after final crown insertion measured by STL superimposition. Acquisition of STL File with an IOS in both time frames, and in an STL reader software (Geomagic Control X) we merge them with the corresponding common landmarks for a best fit alignment. Measure include, Total bone and soft tissue volume loss (in cubic centimeters). Bone collapse measured in mm from the most buccal point to most palatal point of the ridge.

Ridge dimensions (Bone and soft tissue from buccal to palatal) Changes from Implant placement in alveolar extraction sockets (Day 1) to final impression, 2 month after osseointegration (Day 2), in Zirconia Immediate Implants

时间窗: 1 year

Physiologic resorption rate (measured in a buccal to palatal dimension) from day 1 - Immediate implant in an alveolar extraction socket to Day 2 - Day of final Impression measured by STL superimposition. Acquisition of STL File with an IOS in both time frames, and in a STL reader software (Geomagic Control X) we merge them with the corresponding common landmarks for a best fit alignment. Measure include, Total bone and soft tissue volume loss (in cubic centimeters). Bone collapse measured in mm from the most buccal point to most palatal point of the ridge.

次要结局

  • Rate of complications(1 Year)
  • Survival Rate of Zirconia Immediate implants(5 years)

研究者

发起方
Implantology Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Andre Chen

Assistant Professor

Implantology Institute

研究点 (1)

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