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NCT Number: NCT07065487

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

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.

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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location status: Recruiting

Location contact

Khaled Zahran, Ph.D.

CONTACT

[email protected]

Mirna Ashraf Anis, B.D.S., M.D.S.

PRINCIPAL_INVESTIGATOR

Mirna Ashraf, B.D.S., M.D.S.

CONTACT

[email protected]

+20 1281771023

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intraoral Scanner - Standard Protocol

Device

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

Device

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

Procedure

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.

Primary outcomes

  1. Mean 3D deviation (in microns) between test and reference scans using digital superimposition.

    Time frame: Immediately after each impression session (Day 0 for each method).

    Accuracy will be assessed by digitally superimposing the scan obtained from each method (conventional splinted impression, standard digital scan, geometric pattern-assisted digital scan) onto a reference scan (conventional method). Specialized software will calculate the mean 3D deviation in microns to quantify spatial accuracy. Lower deviation indicates higher accuracy.

Secondary outcomes

  1. Number of frameworks exhibiting passive fit as determined by the one-screw test.

    Time frame: Within 1 hour of framework placement following each impression method.

    Clinical assessment of framework passivity will be performed using the one-screw test. A passive fit will be recorded if no lifting or rocking is observed upon tightening a single screw at one end of the framework while the others remain untightened. Count and percentage of frameworks with passive fit will be reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Khaled M. Zahran

CONTACT

20 50 2200150

Mirna A. Anis

CONTACT

[email protected]

+20502522062

Sponsors and collaborators

Lead sponsor

Mirna ashraf anis heneen

Other

Registry information

Official study title

Accuracy of Standard vs Geometric Pattern-Assisted Digital Scanning Techniques for Construction of Full Arch Implant Prosthesis Framework: A Crossover Study

Acronym: GPA Scan

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 15, 2025
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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