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Accuracy of Standard and Geometric Pattern-Assisted Digital Scanning for Full-Arch Implant Prosthesis Frameworks (GPA Scan)

M

Mirna ashraf anis heneen

Status

Enrolling

Conditions

Edentulous Jaw
Prosthodontics
Dental Prosthesis, Implant-Supported
Dental Implantation, Endosseous

Treatments

Device: Intraoral Scanner - Standard Protocol
Device: Intraoral Scanner with Geometric Reference Pattern
Procedure: Conventional Splinted Impression Technique

Study type

Interventional

Funder types

Other

Identifiers

NCT07065487
MU-PROS-2025-001

Details and patient eligibility

About

This clinical trial aims to compare three different impression techniques used to fabricate full-arch implant-supported dental prostheses. Accurate impressions are essential to ensure a passive and precise fit of the final prosthetic framework, which contributes to long-term implant success and patient comfort.

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.

Full description

This is a prospective, crossover clinical trial designed to evaluate and compare the accuracy of three different impression techniques used in the fabrication of full-arch implant-supported prosthesis frameworks. The study includes four participants, each with four osseointegrated dental implants in the mandibular arch.

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.

Enrollment

4 estimated patients

Sex

All

Ages

30 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Adults aged 30 to 70 years

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

Systemic diseases or conditions that affect bone healing or implant integration

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

4 participants in 3 patient groups

Conventional Splinted Impression
Experimental group
Description:
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.
Treatment:
Procedure: Conventional Splinted Impression Technique
Standard Digital Scan
Experimental group
Description:
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.
Treatment:
Device: Intraoral Scanner - Standard Protocol
Geometric Pattern-Assisted Digital Scan
Experimental group
Description:
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.
Treatment:
Device: Intraoral Scanner with Geometric Reference Pattern

Trial contacts and locations

1

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Central trial contact

Mirna A. Anis; Khaled M. Zahran

Data sourced from clinicaltrials.gov

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