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OpenTrials
Completed

NCT Number: NCT07370701

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

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.

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Key information

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Ain Shams University

Cairo, Organization of African Unity Street,, 02, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Open tray impression technique

Other

dental implant then open tray impression technique

Auxiliary Geometric Device (M600)

Other

analyze the accuracy and passivity of complete-arch digital scans of completely edentulous arches by placing auxiliary geometric device

Auxiliary Geometric Device (PS)

Other

analyze the accuracy and passivity of complete-arch digital scans of completely edentulous arches by placing auxiliary geometric device

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 27, 2026
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.