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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.
• Устройство 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.
• Процедура 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.

Первичные конечные точки

• Mean 3D deviation (in microns) between test and reference scans using digital superimposition. [Срок оценки: Immediately after each impression session (Day 0 for each method).]

Вторичные конечные точки (1)

• Number of frameworks exhibiting passive fit as determined by the one-screw test. [Срок оценки: Within 1 hour of framework placement following each impression method.]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Египет · 1 центр

• Mansoura University — Al Mansurah

Идентификаторы

NCT: NCT07065487 · MU-PROS-2025-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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