- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07643441
Accuracy of Complete-Arch Implant Photogrammetry
Accuracy of Complete-arch Implant Scans Obtained Using Intraoral Photogrammetry and a Mobile-phone Based Photogrammetry.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Accurate recording of implant positions is essential for the passive fit and long-term success of complete-arch implant-supported prostheses. Photogrammetry-based technologies have emerged as promising alternatives to conventional digital impression techniques for capturing implant positions with high accuracy. While intraoral photogrammetry systems have demonstrated favorable results, the clinical performance of recently introduced mobile-phone-based photogrammetry systems remains insufficiently investigated.
This prospective comparative clinical study aims to evaluate the accuracy and chairside time of complete-arch implant scans obtained using an intraoral photogrammetry system and a mobile-phone-based photogrammetry system in edentulous patients restored with complete-arch implant-supported prostheses. Each participant will undergo implant scanning using both systems according to the manufacturers' recommendations. The resulting digital datasets will be compared with a reference dataset to determine scan accuracy.
The primary outcome measures will be linear and angular discrepancies between the implant positions captured by each photogrammetry system and the reference dataset. Secondary outcome measures will include the chairside time required for scan acquisition. Statistical analyses will be performed to compare the accuracy and efficiency of the evaluated systems.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Mohammed El-Sawy, PhD
- Número de teléfono: 00201061314522
- Correo electrónico: mohamed.elsawy@dent.menofia.edu.eg
Ubicaciones de estudio
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Menoufia
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Shibīn al Kawm, Menoufia, Egipto, 2266166
- Reclutamiento
- Mohammed El-Sawy
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Contacto:
- Mohammed Elsawy
- Correo electrónico: mohamed.elsawy@dent.menofia.edu.eg
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Adults aged 18 years or older.
- Completely edentulous patients rehabilitated with implant-supported complete-arch prostheses.
- Presence of at least four osseointegrated implants in the edentulous arch.
- Patients able to undergo digital implant scanning procedures.
- Patients willing to participate and provide written informed consent.
Exclusion Criteria:
- Patients with unstable or failed implants.
- Presence of peri-implant disease, active oral infection, or significant soft-tissue inflammation around the implants.
- Inadequate access for placement of photogrammetry scan bodies or markers.
- Patients with conditions that prevent proper scanning procedures (e.g., inability to maintain mouth opening or remain still during data acquisition).
- Patients requiring immediate implant placement or immediate loading protocols.
- Patients unwilling or unable to provide informed consent.
- Incomplete clinical records or inability to complete all study procedures.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Intraoral Photogrammetry (IPG)
Participants will undergo complete-arch implant scanning using an intraoral photogrammetry system (IPF Elite, Shining 3D).
Implant positions will be digitally recorded according to the manufacturer's instructions.
Linear and angular discrepancies relative to the reference dataset, as well as chairside scanning time, will be evaluated.
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A photogrammetry-based digital impression system used to capture the three-dimensional positions of implants in complete-arch rehabilitations.
The system records implant locations through specialized scan bodies and generates a digital dataset for subsequent accuracy analysis.
Otros nombres:
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Mobile-Phone-Based Photogrammetry
Participants will undergo complete-arch implant scanning using a mobile-phone-based photogrammetry system (T-Marker).
Implant positions will be digitally recorded according to the manufacturer's instructions.
Linear and angular discrepancies relative to the reference dataset, as well as chairside scanning time, will be evaluated.
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A smartphone-assisted photogrammetry system used to capture the three-dimensional positions of implants in complete-arch rehabilitations.
The system acquires photographic data through coded markers and generates a digital dataset for subsequent accuracy analysis.
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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Linear Discrepancy of Complete-Arch Implant Scans
Periodo de tiempo: Immediately after scan acquisition and digital analysis (same study visit).
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Assessment of the linear deviation (μm) between implant positions captured using intraoral photogrammetry and mobile-phone-based photogrammetry systems and those recorded in the reference dataset.
Lower values indicate greater accuracy.
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Immediately after scan acquisition and digital analysis (same study visit).
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Mohammed A. El-Sawy, PhD, Menoufia 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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ADMNF-000026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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