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Completed

NCT Number: NCT07037407

Intraoral Scan Versus Conventional Impression in Edentulous Patients With Flabby Ridges

In vivo prospective clinical study will be designed, 12 participants will be included. After intraoral scanning, a conventional impression is made for each patient. The groups will be compared for accuracy.

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

October University for Modern Sciences and Arts

Giza, Egypt

About this study

  • Recruit 12 eligible edentulous patients
  • Scanning Process: Perform five intraoral scans (IOS) of the maxillary flabby ridges for each patient.

. WTI: perform five WTI for each patient

  • STL Export: Export scans and corresponding cast scans obtained via the Window Technique Impression (WTI) as STL files using the intraoral scanner software.
  • 3D Distance Measurement: Import IOS and cast STL files into Geomagic Wrap 2017 for a two-phase best-fit alignment, using the Cast scan as the reference for evaluating trueness and precision.
  • Comparison of Scans:
  • Compare the IOS scan and corresponding cast scan obtained via the Window Technique Impression (WTI) to calculate trueness -compare WTI and corresponding cast scan obtained via the Window Technique Impression (WTI) to calculate trueness-
  • Compare each of the five IOS impressions by using each scan as a reference against the others to calculate precision.
  • Compare each of the five WTI impressions by using each scan as a reference against the others to calculate precision. • Deviation Analysis: Generate a color difference map of each superimposition for visual analysis of deviation patterns.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Inclusion criteria for participant selection will be as follows: 1. completely edentulous patients with maxillary flabby ridge; 2. Absence of infectious diseases; 3. Systemic good health (ASA-1/ASA-2). .; 4. Age between 50 and 75 years; 5. Willingness to cooperate throughout the data collection process.

Exclusion criteria

Exclusion criteria included: 1. Presence of any remaining teeth; 2. Inability to comprehend the study's objectives and procedures; 3. ridge defect or lesion; 4. Postoperative scarring on the ridge; 5. Limitations in mouth opening.

Treatment and study plan

IOS

Procedure

Intra oral scanning

WTI

Procedure

window technique Impression

Primary outcomes

  1. accuracy evaluation

    Time frame: 1 month

    Accuracy Evaluation: The accuracy of the digital impressions versus conventional impression based on trueness and precision will be evaluated.

    • Trueness: Trueness is the degree of agreement between the digital impression and the reference scan. To assess trueness, we will measure the deviation between the reference and scanned files.

    Precision: Precision is a statistical measure that quantifies the level of similarity between repeated samples within the same group. In the context of this study, the IOS impression STL files will be compared to each other in a manner similar to the previous comparisons

Sponsors and collaborators

Lead sponsor

October University for Modern Sciences and Arts

Other

Registry information

Official study title

Accuracy Assessment of Intraoral Scan Versus Conventional Impression in Edentulous Patients With Flabby Ridges: A Prospective Clinical Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 25, 2025
Registry last updated
Jun 25, 2025

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.

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