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临床试验/NCT03992300
NCT03992300已完成不适用

Comparison of Accuracy and Timing Parameter of Digital and Conventional Impression Techniques on Fully Edentulous Jaws: an in Vivo Study

Universitat Internacional de Catalunya1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2019年5月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
1
主要终点
Accuracy of the framework

研究概览

简要总结

Purpose: To determine if adjustment of full-arch zirconia frameworks processed on a model obtained with an intraoral scanner and an auxiliary device is not inferior to that of identical frameworks obtained from an elastomeric impression.

Materials and methods: Eight consecutive patients ready for a full-arch rehabilitation on already osseointegrated implants were selected. Two sets of impressions were taken, one open tray with polyether and splinted impression copings and a second one with an intraoral scanner. A verification plaster jig was used for the elastomeric impression and a prefabricated auxiliary device was used to adjust the optical intraoral impressions. Two full-zirconia frameworks with the same design were processed and tested on the patient by two independent calibrated operators. Accuracy of both frameworks was measured by calibrated blinded operators, who determined tactile adjustment, Sheffield test, radiographic adjustment, and screwing torque. Overall perception of adjustment was used to determine the better framework to be delivered to the patient.

Hº: Frameworks obtained from an impression taken with an intraoral scanner are not inferior in accuracy to those obtained from a conventional elastomeric impression

详细描述

Eight consecutive patients ready for a full-arch rehabilitation on previously osseointegrated implants, and who had received an immediately loaded prosthesis, were selected. All implants had multiunit abutments placed on top. Cases from 4 to 6 implants were accepted, either upper or lower arches. Three sets of impressions were taken to each patient:

Conventional impression:

Open tray impression copings were screwed on top of all implants in the arch using a torque wrench set at 10 N/cm. Impression copings were splinted by means of Triad Gel clear resin, with an at least 3mm diameter in the resin connectors. Once the resin was photo-polymerized a cut was done in the centre of each connection with a 0.3 mm bur, to eliminate possible stress in the structure, and then it was splinted again with a drop of Triad Gel in each cut. A polyether impression was taken by means of a perforated plastic tray, and a master model was fabricated following the manufacturer's instructions. A plaster verification jig was fabricated on the model. After one week the patient came to the dental clinic where vertical dimension of occlusion was determined and the plaster key was screwed in the patient mouth to check passivity. In case the key had been fractured, a new impression would have been taken, and if not, final prosthesis could be processed.

Optical impression:

An impression of the antagonist and an impression of the edentulous arch with the healing abutments in place were taken by means of an optical scanner following the manufacturers protocol. The position of the implants was marked in the working standard tessellation language (STL) model, and the software cut a circle on top of those areas. The files were copied, and two datasets were obtained.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Device Feasibility
盲法
Single (Outcomes Assessor)

盲法说明

The frameworks are marked with a triangle or a circle in the distal aspect of the distal right molar. The outcomes assessor does not now to which group corresponds each framework

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •·Patients with four or more implants already osseo-integrated ready to rehabilitate with a full-arch implant-supported framework of 10 or more units. ·Upper or lower jaw.

排除标准

  • •Implants not suitable for multiunit abutments.
  • •More than six implants.
  • •Peri-implantitis present in any implant.
  • •Need of a removable prosthesis.
  • •Patients unable to understand the purpose of the study.
  • •Patients with a restorative space higher than 15 milimiters.

研究组 & 干预措施

Intraoral scanning

Experimental

An intraoral scanning is taken. An auxiliary device is used to achieve better accuracy. A zirconia framework is produced

干预措施: Clinical adjustment (Device)

Conventional scanning

Active Comparator

A conventional elastomeric impression is taken and a zirconia framework is produced

干预措施: Clinical adjustment (Device)

结局指标

主要结局

Accuracy of the framework

时间窗: one day

Overall perception of adjustment of the two frameworks

次要结局

  • Radiographic adjustment(1 day)
  • Perception of the passivity(1 day)
  • Optical adjustment(1 day)
  • Screwing torque(1 day)

研究者

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

Miguel Roig Cayón

Professor and Chair Department of Restorative Dentistry

Universitat Internacional de Catalunya

研究点 (1)

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