Intraoral Scan Versus Conventional Impression in Edentulous Patients With Flabby Ridges

NCT ID: NCT07037407

Last Updated: 2025-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-18

Study Completion Date

2025-04-24

Brief Summary

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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

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* 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.

Conditions

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Edentulism Edentulous Alveolar Ridge Edentulous Alveolar Ridge With Labial Resorption Flabby Ridge

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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WTI

Control: Window technique for Maxillary flabby ridge using two consistencies of PVS impression material then poured to obtain a stone model which will be scanned using a laboratory extra oral scan to convert it into an STL file (WTI)

Group Type ACTIVE_COMPARATOR

WTI

Intervention Type PROCEDURE

window technique Impression

IOS

intra oral scanning of flabby ridge

Group Type EXPERIMENTAL

IOS

Intervention Type PROCEDURE

Intra oral scanning

Interventions

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IOS

Intra oral scanning

Intervention Type PROCEDURE

WTI

window technique Impression

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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October University for Modern Sciences and Arts

OTHER

Sponsor Role lead

Responsible Party

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Dina ElAwady

Associate Prof Of Prosthodontics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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October University for Modern Sciences and Arts

Giza, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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MSA University REC-D4210-4

Identifier Type: -

Identifier Source: org_study_id

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