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临床试验/NCT07370701
NCT07370701已完成不适用

Evaluation of Passivity of Co-Cr Complete Arch Screw Retained Maxillary Prostheses Using Different Intraoral Scanners With the Aid of Auxiliary Geometric Device

Ain Shams University1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2023年6月8日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
7
试验地点
1
主要终点
estimate the marginal gap using digital camera

研究概览

简要总结

Statement of the problem: Accurate digital scans of edentulous patients is challenging due to the absence of anatomic landmarks and geometric variations along the dental arch. Whether adding an auxiliary geometric device (AGD) will improve scanning is unclear.

Purpose: The aim of the study is to analyze the accuracy of complete-arch digital scans of completely edentulous arches by placing auxiliary geometric device.

Material and Methods: This in vivo study included patients who received complete arch screw-retained prostheses supported by 4 implants. Seven patients were randomly chosen; a dual scan protocol was performed for digital implant planning. Surgical guide and AGD were 3d printed. Three different data acquisition methods for each individual: Open tray impression digitized by extraoral scanner (EO Group), Intraoral scan by using Medit i600 with AGD (M600 Group), and Intraoral scan (CEREC Primescan; Dentsply Sirona) with AGD (PS Group). A reference model was formed to check the accuracy of these 3 data acquisitions. The framework was designed and printed for the 3 groups to be placed in the reference model to check the passivity. Passivity was tested through modified 1-screw test by measuring the marginal gap by using a digital camera (add magnification). Each framework was placed in the patient's mouth to re-check the passivity, the best one was delivered to the patient after 4 months after osteointegration of the implants.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • For a maxillary edentulous patient, the last extraction should be at least six months
  • Non-smokers
  • 50-70 years of age
  • Have good oral hygiene and motivation.

排除标准

  • Patients with major systemic diseases that may affect osseointegration
  • Uncontrolled diabetes mellitus
  • The need for extensive bone grafting in the planned implant site
  • Pregnant female patient
  • Under bisphosphonate treatment
  • Limited mouth-opening for executing the guided implant surgery.

研究组 & 干预措施

Open tray impression digitized by extraoral scanner (EO Group)

Experimental

A reference model was formed to check the accuracy of these 3 data acquisitions. The framework was designed and printed for the 3 groups to be placed in the reference model to check the passivity. Passivity was tested through modified 1-screw test by measuring the marginal gap by using a digital camera (add magnification). Each framework was placed in the patient's mouth to re-check the passivity, the best one was delivered to the patient after 4 months after osteointegration of the implants.

干预措施: Open tray impression technique (Other)

Intraoral scan by using Medit i600 with AGD (M600 Group)

Experimental

A reference model was formed to check the accuracy of these 3 data acquisitions. The framework was designed and printed for the 3 groups to be placed in the reference model to check the passivity. Passivity was tested through modified 1-screw test by measuring the marginal gap by using a digital camera (add magnification). Each framework was placed in the patient's mouth to re-check the passivity, the best one was delivered to the patient after 4 months after osteointegration of the implants.

干预措施: Auxiliary Geometric Device (M600) (Other)

Intraoral scan (CEREC Primescan; Dentsply Sirona) with AGD (PS Group)

Experimental

A reference model was formed to check the accuracy of these 3 data acquisitions. The framework was designed and printed for the 3 groups to be placed in the reference model to check the passivity. Passivity was tested through modified 1-screw test by measuring the marginal gap by using a digital camera (add magnification). Each framework was placed in the patient's mouth to re-check the passivity, the best one was delivered to the patient after 4 months after osteointegration of the implants.

干预措施: Auxiliary Geometric Device (PS) (Other)

结局指标

主要结局

estimate the marginal gap using digital camera

时间窗: after 4 months after osteointegration of the implants

modified single screw test to check the passivity of the 3 frameworks in both the models and in the patient's mouth by radiograph

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

Yasmine Hamdy Abdel-Hay Dawood

Assistant Lecturer of Oral and Maxillofacial Prosthodontics

Ain Shams University

研究点 (1)

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