Accuracy of Standard and Geometric Pattern-Assisted Digital Scanning for Full-Arch Implant Prosthesis Frameworks
NCT ID: NCT07065487
Last Updated: 2025-07-15
Study Results
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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RECRUITING
NA
4 participants
INTERVENTIONAL
2025-09-30
2026-09-15
Brief Summary
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In this crossover study, participants with four osseointegrated dental implants in the lower jaw will undergo three types of impressions:
Conventional splinted impression using polyvinyl siloxane (PVS) material.
Standard digital impression using an intraoral scanner.
Geometric pattern-assisted digital impression, which incorporates a visual reference pattern to improve scan alignment and accuracy.
Each participant will receive all three impression techniques in a randomized sequence, at different time points. The accuracy of each method will be assessed by evaluating the passivity of the resulting prosthetic frameworks using two methods: (1) digital superimposition analysis to measure three-dimensional (3D) spatial deviation, and (2) the clinical "one-screw test" to detect misfit.
The study seeks to determine whether digital scanning, particularly with geometric pattern assistance, can provide accuracy comparable to or better than conventional methods. Findings may guide improvements in digital prosthodontic workflows and support more efficient, predictable treatment outcomes.
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Detailed Description
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The three impression techniques being compared are:
Conventional Splinted Impressions: A traditional method utilizing rigidly splinted impression copings and polyvinyl siloxane (PVS) impression material to capture implant positions.
Standard Digital Scanning: A fully digital technique using an intraoral scanner and scan bodies placed on the implants to generate a digital impression.
Geometric Pattern-Assisted Digital Scanning: An enhanced digital method incorporating a geometric reference pattern during the scanning process to improve stitching accuracy and reduce scan distortion across the arch.
Each participant will receive all three impression techniques in a randomized sequence to minimize order bias. Digital models will be generated from each impression method, and test frameworks will be designed using computer-aided design/computer-aided manufacturing (CAD/CAM) technology. These frameworks will be fabricated using 3D laser sintering.
The primary outcome of the study is the assessment of accuracy, defined as the mean three-dimensional (3D) deviation between the test scan and a reference scan, measured via digital superimposition software. A secondary outcome is clinical passivity, evaluated using the one-screw test to detect any misfit between the framework and implant interfaces.
The results of this study aim to provide clinical evidence regarding the accuracy and feasibility of advanced digital impression techniques, particularly the use of geometric pattern references, in full-arch implant prosthodontics. This may support improvements in digital workflow reliability, patient outcomes, and prosthetic longevity.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
NONE
Study Groups
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Conventional Splinted Impression
Participants will undergo a conventional impression technique using open-tray impression copings rigidly splinted with DuraLay resin. The impression is taken using polyvinyl siloxane (PVS) material in a custom tray. This method serves as the control for comparison with digital techniques.
Conventional Splinted Impression Technique
A physical impression is taken using open-tray impression copings splinted with DuraLay resin and polyvinyl siloxane (PVS) material in a custom tray, according to conventional protocols for full-arch implant prostheses.
Standard Digital Scan
Participants will undergo a full-arch digital scan using an intraoral scanner. Scan bodies will be attached to the multi-unit abutments, and the scan will be performed without any additional geometric reference aids.
Intraoral Scanner - Standard Protocol
A full-arch digital impression is obtained using a high-precision intraoral scanner. Scan bodies are placed on multi-unit abutments and scanned without the use of external reference markers or geometric aids. The scan follows the manufacturer-recommended scanning path to capture the complete arch. This serves as a baseline digital technique for comparison with geometric pattern-assisted scanning.
Geometric Pattern-Assisted Digital Scan
Participants will undergo a full-arch digital scan using an intraoral scanner, with the addition of a geometric reference pattern placed in the scanning field to improve stitching accuracy and scan reliability.
Intraoral Scanner with Geometric Reference Pattern
The same intraoral scanner is used, but with an additional geometric reference pattern introduced in the scanning field to improve stitching accuracy and alignment of the digital scan.
Interventions
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Intraoral Scanner - Standard Protocol
A full-arch digital impression is obtained using a high-precision intraoral scanner. Scan bodies are placed on multi-unit abutments and scanned without the use of external reference markers or geometric aids. The scan follows the manufacturer-recommended scanning path to capture the complete arch. This serves as a baseline digital technique for comparison with geometric pattern-assisted scanning.
Intraoral Scanner with Geometric Reference Pattern
The same intraoral scanner is used, but with an additional geometric reference pattern introduced in the scanning field to improve stitching accuracy and alignment of the digital scan.
Conventional Splinted Impression Technique
A physical impression is taken using open-tray impression copings splinted with DuraLay resin and polyvinyl siloxane (PVS) material in a custom tray, according to conventional protocols for full-arch implant prostheses.
Eligibility Criteria
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Inclusion Criteria
Completely edentulous mandible
Presence of four osseointegrated implants in the lower jaw
Good oral and general health
Willingness to participate and provide written informed consent
Availability for all study appointments
Exclusion Criteria
Presence of oral inflammation, infection, or soft tissue abnormalities at implant sites
History of bruxism or parafunctional habits
Inability to understand or comply with study procedures
30 Years
70 Years
ALL
Yes
Sponsors
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Mirna ashraf anis heneen
OTHER
Responsible Party
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Mirna ashraf anis heneen
Assistant Lecturer of Prosthodontics, Horus University, Damietta - PhD Candidate, Mansoura University
Locations
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Mansoura University
Al Mansurah, Dakahlia Governorate, Egypt
Countries
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Central Contacts
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Khaled M. Zahran
Role: CONTACT
Facility Contacts
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Other Identifiers
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MU-PROS-2025-001
Identifier Type: -
Identifier Source: org_study_id
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