跳至主要内容
临床试验/NCT06425770
NCT06425770招募中不适用

Investigating the Accuracy of Conventional vs Digital Impressions and Conventional vs 3D Fabricated Casts in Capturing the Emergence Profile Around Maxillary Anterior Single Implant-supported Crowns

Semmelweis University2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年10月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
15
试验地点
2
主要终点
3D RMS - root mean square difference

研究概览

简要总结

This study compares conventional impression and cast fabrication to direct/indirect digital scannig and 3D printed casts regarding their accuracy in replicating the peri-implant emergence profile of single implants in the maxillary anterior region (FDI #15-25).

详细描述

Correct design of the peri-implant emergence profile (EP) is crucial for maintaining the health of the supracrestal complex and long-term success of the implant implant-prosthodontics. After its formation with a provisional restoration, its shape needs to be transferred to the final restoration via conventional elastomeric or digital (direct/indirect) impression taking.

Our aims are to investigate around maxillary anterior single implants in patients with thick gingival phenotype:

  1. the accuracy of direct digital impression vs indirect digital impression vs conventional elastomeric impression in capturing the EP and implant position
  2. the accuracy of 3D printed cast with conventional gingival mask vs conventional epoxy-resin cast with gingival mask in replicating the EP and implant position
  3. the amount of soft tissue collapse at 0,2,10,20 minutes following the removal of the provisional restoration in case of direct EP scanning

研究设计

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

入排标准

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

入选标准

  • Adult above 18 yo
  • No systematic deseases
  • Good oral hygene (FMPS < 25%)
  • Stable occlusion
  • Thick phenotype
  • Single missing maxilary anterior (FDI #15-25 position) tooth replaced with osseointegrated bone level impant
  • Correctly formed soft tissue with CAD/CAM temporary abutment for min. 3 months
  • Neighbouring teeth in place and in good condition
  • Patient voluntarily accepts and signs the patient leaflets for the trial

排除标准

  • Active periodontitis
  • Peri-implant inflammation

结局指标

主要结局

3D RMS - root mean square difference

时间窗: at impression taking, 0,2,10,20 mins

The absolute mean deviation between the emergence profiles replicated with different impression techniques along the whole surface of the EP

次要结局

  • Linear vertical soft tissue change(at impression taking, 0,2,10,20 mins)
  • Linear horizontal soft tissue change(at impression taking, 0,2,10,20 mins)
  • 2D RMS - root mean square difference(at impression taking, 0,2,10,20 mins)
  • Patient reported outome measures - evaluation of the impression method(at the end of each session of the digital and conventional impression taking)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验