Accuracy of the Calibrated Framework for Intra Oral Full Arch Scan (A Cross-over Study)
Accuracy of the Calibrated Framework for Intraoral Full-Arch Scanning Compared With Conventional Splinted Open-Tray Impression in Edentulous Patients: A Crossover Clinical Trial
This crossover clinical trial aims to compare the accuracy of conventional splinted open-tray implant impressions with intraoral digital scanning using a calibrated framework in completely edentulous patients rehabilitated with full-arch implant-supported prostheses. Accurate transfer of implant positions is essential for achieving a passive fit of the prosthetic framework and minimizing biological and mechanical complications.
Twenty healthy completely edentulous patients requiring full-arch implant rehabilitation will be enrolled. Each participant will undergo both conventional and digital impression techniques following implant placement, allowing direct within-subject comparison. The conventional technique consists of a verified splinted open-tray impression, while the digital technique uses an intraoral scanner in combination with a calibrated stock framework.
The accuracy of the two impression techniques will be evaluated by superimposing the resulting STL files using Geomagic Control X software. Linear deviations in the x-, y-, and z-axes, angular deviations, and global deviations will be measured and compared. The findings of this study are expected to provide clinical evidence regarding the accuracy of calibrated framework-assisted intraoral scanning compared with the conventional impression technique for full-arch implant rehabilitation.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
The passive fit of full-arch implant-supported prostheses is a critical factor influencing the long-term success of implant rehabilitation. Because dental implants lack a periodontal ligament, inaccuracies in transferring implant positions may result in framework misfit, leading to biological and mechanical complications such as screw loosening, component fracture, or implant failure. Conventional splinted open-tray impressions are considered the reference standard for full-arch implant impressions; however, they are technique-sensitive, time-consuming, and susceptible to material distortion and operator-related errors.
Advances in digital dentistry have enabled the use of intraoral scanners for implant impressions. Nevertheless, complete-arch digital scanning remains challenging because cumulative stitching errors may reduce scanning accuracy. The use of a calibrated framework has recently been proposed to improve the accuracy of complete-arch intraoral scanning by providing stable geometric reference points during image acquisition. Although promising, clinical evidence comparing this technique with the conventional splinted open-tray impression technique remains limited.
The purpose of this crossover clinical trial is to compare the accuracy of conventional splinted open-tray impressions and intraoral digital scanning using a calibrated framework in completely edentulous patients receiving full-arch implant rehabilitation.
Twenty healthy completely edentulous patients will be recruited. Following implant placement, each participant will undergo both impression techniques. The conventional workflow will consist of a verified splinted open-tray implant impression, while the digital workflow will involve intraoral scanning using a calibrated stock framework attached to implant scan bodies. STL datasets obtained from both techniques will be analyzed using Geomagic Control X software. The digital models will be superimposed to assess linear deviations along the x-, y-, and z-axes, angular deviations, and global three-dimensional deviations. The results will be statistically analyzed to determine whether the calibrated framework-assisted digital workflow provides transfer accuracy comparable to or greater than the conventional impression technique.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: noor alhuda raheem, BDS
- Número de teléfono: 01044487126
- Correo electrónico: nooralkhalil95@yahoo.com
Ubicaciones de estudio
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Al Mansurah, Egipto, 12345
- Reclutamiento
- Noor Alhuda Rahemm Khalil
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Contacto:
- osama asker, PHD
- Número de teléfono: 01010848407
- Correo electrónico: osamaasker@gmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Adults aged 18 years or older.
- Completely edentulous maxilla and mandible for at least 6 months following the last tooth extraction.
- Angle's Class I maxillomandibular relationship with adequate interarch space.
- Sufficient residual alveolar bone quantity and quality to receive dental implants.
- Good oral hygiene.
- Free from uncontrolled systemic diseases or conditions that may interfere with implant osseointegration.
- Able and willing to provide written informed consent.
Exclusion Criteria:
- Temporomandibular joint disorders or parafunctional habits.
- Heavy smokers.
- Uncontrolled systemic diseases.
- History of chemotherapy or radiotherapy to the head and neck region.
- Poor neuromuscular coordination.
- Localized bone defects that could compromise implant placement.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Conventional Splinted Open-Tray Impression
Participants will undergo a conventional verified splinted open-tray implant impression following implant placement. Impression copings will be splinted using dental floss and autopolymerizing resin, and a polyvinyl siloxane (PVS) impression will be made. The resulting master cast will be digitized using a laboratory scanner to generate an STL file for accuracy assessment. |
A conventional verified splinted open-tray implant impression will be performed after implant placement. Multi-unit impression copings will be splinted using dental floss and autopolymerizing resin, followed by a polyvinyl siloxane (PVS) impression. The master cast will be fabricated, verified, and scanned with a laboratory scanner to generate an STL file for accuracy analysis.
Otros nombres:
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Experimental: Intraoral Digital Scanning with Calibrated Framework
Participants will undergo intraoral digital scanning using an intraoral scanner and a calibrated stock framework attached to implant scan bodies after implant placement. The generated STL file will be compared with the conventional impression using Geomagic Control X software to evaluate transfer accuracy. |
An intraoral digital impression will be obtained after implant placement using an intraoral scanner and a calibrated stock framework attached to implant scan bodies. The resulting STL dataset will be compared with the conventional impression using Geomagic Control X software to evaluate linear, angular, and global deviations in implant position transfer accuracy.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Implant Position Transfer Accuracy (Linear deviations)
Periodo de tiempo: Immediately after impression procedures following implant placement (same study visit).
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by superimposing STL files obtained from the conventional splinted open-tray impression and intraoral digital scanning using a calibrated framework with Geomagic Control X software. Linear deviations (x-, y-, and z-axes) |
Immediately after impression procedures following implant placement (same study visit).
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Implant Position Transfer Accuracy (Angular deviations)
Periodo de tiempo: Immediately after impression procedures following implant placement (same study visit).
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Accuracy of implant position transfer will be assessed by superimposing STL files obtained from the conventional splinted open-tray impression and intraoral digital scanning using a calibrated framework with Geomagic Control X software |
Immediately after impression procedures following implant placement (same study visit).
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: osama asker, PHD, Mansoura University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- MS.26.01.135
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
upon request from the corresponding author
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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