Intraoral Scan Versus Conventional Impression in Edentulous Patients With Flabby Ridges

Not Applicable

Completed

• Conditions: Edentulism; Edentulous Alveolar Ridge; Edentulous Alveolar Ridge With Labial Resorption; Flabby Ridge

• Registration Number: NCT07037407
• Lead Sponsor: October University for Modern Sciences and Arts

Brief Summary

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.

Detailed Description

* 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.

Study Timeline

• Study Start: 2024-10-18
• Primary Completion: 2025-03-24
• Study Completion: 2025-04-24
• Status Verified: 2025-06
• Study First Submitted: 2025-06-12
• Study First Submitted QC: 2025-06-21
• Last Update Submitted: 2025-06-21
• Study First Posted: 2025-06-25
• Last Update Posted: 2025-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
accuracy evaluation	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

Trial Locations

Locations (1)

October University for Modern Sciences and Arts; 🇪🇬 Giza, Egypt