Accuracy of Full Arch Intraoral Scanning

NCT06870929 | Active Not Recruiting

• 1 other identifier: FDASU-RecIR022544
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Although an intraoral scanner IOS can offer the clinician a completely digital workflow, achieving trustworthy digital scans in edentulous jaws is challenging because of the lack of fixed anatomical landmarks. From this perspective, several methods have been proposed to improve the accuracy of digital scanning, however, related results remain inconclusive, and previously proposed devices have had limitations, such as bulkiness, excessive manufacturing requirements, and poor commercial applicability. Thus, this study aims to clinically compare the effect of conventional versus photogrammetry intraoral scanning methods on the passive fit of mandibular all-on four screw-retained frameworks.

Conditions

Completely Edentulous

Keywords

intraoral scanner; photogrammetry; full arch implant restorations; passive fit; one-screw test; screw resistance test

Outcome Measures

Primary Outcomes (1)

• Clinical assessment of passive fit following the latest update of the one screw test

  Three CAD/Milled frameworks for each subject will be realized based on the acquired scans. The passive fit of each framework will be assessed intraorally following the Sheffield test: The test Part I involves checking the fit of the framework using finger pressure then tightening one of the most distal abutment screws. when an accurate horizontal and perpendicular fit viewed under magnification (will be categorized as 3 or excellent). If a slight "shadow" or suspicion of a vertical discrepancy, exists between the framework and abutment, a satisfactory passive fit will be confirmed by part 2 of test; If a suspected fit discrepancy can be closed using a 13mm wide modelling wax strip, representing 20 KN/m2 pressure load without distorting, then the fit is deemed to be clinically acceptable (categorized as 2 or good). If the wax does distort or is unable to close the discrepancy, will be (categorized as 1 or poor). this categorization arbitrarily defined by authors.

  six months

Secondary Outcomes (1)

• objective assessment of clinical passive fit using the screw resistance test parameter

  six months

Study Arms (3)

Simple splinting-assisted intraoral scanning

ACTIVE COMPARATOR

The Medit i600 direct intraoral classical scans will be obtained while applying only a basic simple splinting

Device: The Photogrammetry-assisted intraoral scanning; Device: The modified approach of splinting-assisted intraoral scanning

modified splinting-assisted intraoral scanning technique

EXPERIMENTAL

The Medit i600 direct intraoral scans will be obtained while applying basic simple splinting along with incorporating a unique tip in the scanning protocol and scanner software

Device: Simple splinting-assisted intraoral scanning

Photogrammetry-assisted intraoral scanning

EXPERIMENTAL

The Medit i600 will be used to obtain direct intraoral scans while the scan bodies are combined with extra photogrammetry system scanning assistance.

Device: Simple splinting-assisted intraoral scanning

Interventions

The Photogrammetry-assisted intraoral scanning DEVICE

The Photogrammetry-assisted intraoral scanning; will be executed using the MUA-compatible ioConnect ® photogrammetry system components exactly in the same sequence as recommended by the manufacturer

Simple splinting-assisted intraoral scanning

The modified approach of splinting-assisted intraoral scanning DEVICE

The scan bodies will be mounted over the MUA and loosely connected with a power chain before the Medit scanner single-shot scanning procedure. Using the additional scan option in the Medit scanner software, another single-shot scan will be obtained and superimposed to the first scan yielding a color map that reflects the accuracy of the obtained scan and directs a highly precise final scan.

Simple splinting-assisted intraoral scanning

Simple splinting-assisted intraoral scanning DEVICE

The Medit i600 direct intraoral classical scans will be obtained while applying only a basic simple splinting

Photogrammetry-assisted intraoral scanning; modified splinting-assisted intraoral scanning technique

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients having a completely edentulous lower arch that could be restored by fixed screw-retained implant prosthesis.
• Patients having a substantial bone height and width at prospective implant sites to install four standard-size implants following the all-on-4 protocol.
• Patients having Sufficient crown height space.

You may not qualify if:

• Patients with bad oral hygiene.
• Patients with limited mouth opening.
• Vulnerable groups.
• Uncooperative patients.
• Patients receiving or undergoing radiotherapy or chemotherapy. Patients with systemic diseases affecting bone metabolism. Smokers.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

faculty of dentistry Ain-Shams university

Cairo, Abbasia, 11566, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer at faculty of dentistry Ain-Shams University

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 11, 2025
• Study Start: March 3, 2025
• Primary Completion: September 3, 2025
• Study Completion: December 3, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-03

Locations

EG (1)