Effect of Scanning Techniques on Accuracy of Mandibular Fixed Detachable Prostheses

Официальное название

Influence of Three Different Scanning Techniques on Scanning Accuracy for Mandibular Fixed Detachable Prosthesis (A Cross Over Study).

Обзор

This crossover clinical study aims to evaluate the influence of three different intraoral scanning techniques on the scanning accuracy and passive fit of mandibular implant-supported fixed detachable prostheses in completely edentulous patients. Each participant will undergo digital implant scanning using three methods: splinted scan bodies, horizontal non-calibrated scan bodies (IO Connect), and auxiliary geometric devices.

Подробное описание

This prospective crossover clinical trial is designed to evaluate and compare the accuracy and passive fit of three different intraoral scanning techniques used for the fabrication of mandibular implant-supported fixed detachable prostheses in completely edentulous patients.

The study will include completely edentulous participants rehabilitated with four osseointegrated implants placed in the mandibular arch. Each participant will undergo digital implant impression procedures using three different scanning .

The three scanning techniques being compared are:

1. Splinted Scan Bodies: Implant scan bodies will be splinted using composite resin before intraoral scanning. 2. Horizontal Non-Calibrated Scan Bodies (IO Connect): Digital impressions will be obtained using the IO Connect horizontal scan body system. 3. Auxiliary Geometric Devices: Digital impressions will be acquired using 3D-printed auxiliary geometric devices attached to the scan bodies to provide additional geometric reference landmarks during scanning.

Digital datasets generated from each scanning technique will be analyzed and compared. Verification jigs will be fabricated using CAD/CAM technology and clinically evaluated.

The primary outcomes of the study are scanning accuracy, assessed by measuring linear deviation (µm) and angular deviation (degrees) between implant positions obtained from the different scanning techniques, and three-dimensional surface deviation analysis, assessed through root mean square (RMS) values and median surface deviation obtained from STL file superimposition.

The secondary outcome is passive fit , which will be evaluated using the Sheffield one-screw test and intraoral periapical radiographic assessment.

The findings of this study will help identify the scanning technique that provides the highest accuracy and best passive fit for mandibular implant-supported fixed detachable prostheses and may contribute to improving digital workflows in complete-arch implant rehabilitation.

Вмешательства

• Устройство Splinted Scan Body with composite
  A full-arch digital implant impression will be obtained using implant scan bodies splinted with composite resin prior to scanning. The splinting procedure will provide enhanced scan body stability and will be used to minimize positional discrepancies during digital impression acquisition.
• Устройство IO Connect Scanning Technique
  A full-arch digital implant impression will be obtained using horizontal non-calibrated scan bodies (IO Connect). The horizontal scan body design will facilitate implant position recognition, digital alignment, and accurate transfer of implant coordinates throughout the digital impression procedure.
• Устройство Auxiliary Geometric Device Scanning Technique
  A full-arch digital implant impression will be obtained using 3D-printed auxiliary geometric devices attached to implant scan bodies. These auxiliary devices will provide additional geometric reference landmarks to improve stitching accuracy, reduce cumulative scanning errors, and enhance complete-arch digital impression accuracy.

Первичные конечные точки

• Implant linear and angular deviation [Срок оценки: Immediately after completion of digital scanning day 0]
• Three-Dimensional part comparison [Срок оценки: Immediately after completion of digital scanning day 0]

Вторичные конечные точки (1)

• fit of verification jig [Срок оценки: Within 1 hour of fabrication and intraoral placement of the verification jig]

Критерии участия

Критерии включения

• Completely edentulous patients with age between 40-60 years.
• Adequate bone height to fulfill the criteria for implant placement.
• Patients should have a class I Angle's classification.

Критерии исключения

1-. Insufficient vertical inter-arch space to accommodate the restorative components.

2\. Presence of psychiatric or neurological conditions. 3. Any systemic diseases that may affect implant bone osteointegration.

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

Оценка устройства

Центры проведения

Египет · 1 центр

• Faculty of Dentistry, Tanta University — Tanta

Идентификаторы

NCT: NCT07740265 · RP-11-25-3482

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗