Passivity of Full-Arch Co-Cr Maxillary Prostheses Using IOS

January 21, 2026 updated by: Yasmine Hamdy Abdel-Hay Dawood, Ain Shams University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Organization of African Unity Street,
      • Cairo, Organization of African Unity Street,, Egypt, 02
        • Faculty of dentistry, ain shams university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open tray impression digitized by extraoral scanner (EO 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.
Other: Open tray impression technique
dental implant then open tray impression technique
Experimental: Intraoral scan by using Medit i600 with AGD (M600 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.
Other: Auxiliary Geometric Device (M600)
analyze the accuracy and passivity of complete-arch digital scans of completely edentulous arches by placing auxiliary geometric device
Experimental: 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.
Other: Auxiliary Geometric Device (PS)
analyze the accuracy and passivity of complete-arch digital scans of completely edentulous arches by placing auxiliary geometric device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
estimate the marginal gap using digital camera
Time Frame: 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
after 4 months after osteointegration of the implants

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Yasmin H Abd El Hay Dawoud, Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2023

Primary Completion (Actual)

March 5, 2025

Study Completion (Actual)

September 5, 2025

Study Registration Dates

First Submitted

January 13, 2026

First Submitted That Met QC Criteria

January 21, 2026

First Posted (Actual)

January 27, 2026

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 21, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FDASU-RecID022318

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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