跳至主要内容
临床试验/NCT05770011
NCT05770011Unknown不适用

Accuracy of Impression Techniques and Their Effect on the Passive Fit of Screw- Retained Bar Splinting Two Interforaminal Implants

Ain Shams University1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2023年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
54
试验地点
1
主要终点
passive fit of screw retained bars

研究概览

简要总结

Objectives: Passive fit of screw retained frameworks is essential to avoid biological and mechanical failures in addition to transmission of unfavourable stresses to the bone-implant interface. However, Several factors contribute to the passive fit of screw retained prosthesis such as relative parallelism between the implants, implant number, impression material, impression technique and method of prothesis fabrication. The current study aims to evaluate the accuracy of three different impression techniques on the fit of screw retained bar splinting two inter-foraminal implants.

Methods: The study presents evaluation of the passive fit of screw retained bar fabricated with three different impression techniques.

详细描述

Surgical guide will be designed for completely edentulous patients. It will be inserted into the patient's mouth, stabilized against the upper denture and secured in place. dental implants will then be placed.

For bar fabrication using the first impression technique, closed-top primary impressions will be made followed by open top secondary impression. Extraoral scanning of the impression will be done followed by digital fabrication of the bar.

For bar fabrication using the second impression technique, scanning of the lower arch will be done using Omnicam intraoral scanner. Scanning will be done by a single calibrated operator who is trained on intraoral scanning techniques.

Scan bodies will be then screwed to the implants and scanning will be done. Both scans will be previewed on the computer desktop and superimposed together. A Standard tessellation language file will be then exported, downloaded and previewed in Inlab Exocad software .Implant system and the bar design will be selected from the software library. Then, the Standard tessellation Language file will be exported to the milling machine and milling of Cobalt chromium bar will be done.

For bar fabrication using the third technique, splinting of scan bodies will be done followed by intraoral scanning of the lower arch.

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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

triple blinded

入排标准

年龄范围
50 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •- Patients' age range from 50 to 65 years old.
  • •Good oral hygiene is mandatory.
  • •Sufficient restorative space (15mm) to accept implant supported over denture diagnosed by mounting the diagnostic casts.
  • •Firm and healthy mucosa covering the alveolar ridge.
  • •Minimum bone width 5.5 mm buccolingually and of 12 mm bone height as diagnosed from the pre-operative cone beam computed tomography scan.

排除标准

  • •Heavy smokers.
  • •Patients with para functional habits.
  • •Tempromandibular Joint Disorders. (TMJ disorders)
  • •Patients with systemic disorders that may affect the results of this study.
  • •V-shaped dental arch.

研究组 & 干预措施

Conventional impression

Active Comparator

Impression will be taken conventionally using rubber base open tray

干预措施: impression material (Device)

digital impression without splinting the scan bodies

Experimental

Impression will be taken by intraoral scaner

干预措施: intraoral scanner of nonsplinted scan bodies (Device)

digital impression with splinting the scan bodies

Experimental

Impression will be taken by intraoral scaner

干预措施: intraoral scanner of splinted scan bodies (Device)

结局指标

主要结局

passive fit of screw retained bars

时间窗: one year

frame work fitting passively using screw resistance test using screw resistance parameter calculated by subtraction of passive and non passive situations angles of rotation in degrees

Angular accuracy of impressions by superimposition

时间窗: 1 year

accurate details recorded by superimposition of the impressions using geomagic software program by measuring angular displacements in degrees

linear accuracy of impressions by superimposition

时间窗: 1 year

accurate details recorded by superimposition of the impressions using geomagic software program by measuring linear deviation in millimeters

次要结局

未报告次要终点

研究者

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

Bassant Sherif Gamal eldin

assistant lecturer of OMF prosthodontics

Ain Shams University

研究点 (1)

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