- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07627841
Accuracy of Computer Guided Implant Placement in Edentulous or Partially Edentulous Patients Using Artificial Intelligence Technology vs Conventional Method A Randomized Clinical Trial
Descripción general del estudio
Estado
Descripción detallada
This clinical study is being conducted at Future University in Egypt as part of a doctoral research project in Oral and Maxillofacial Surgery. The purpose of the study is to evaluate and compare the accuracy of dental implant placement using two different computer-guided techniques: an Artificial Intelligence (AI)-assisted digital planning method and a conventional computer-guided planning method.
Dental implants are commonly used to replace missing teeth and restore oral function and appearance. Accurate implant placement is very important to avoid complications and to ensure long-term success. Modern implant dentistry increasingly depends on digital planning and 3D surgical guides to improve safety and precision during surgery.
In this study, patients who are partially or completely missing teeth will undergo clinical examination and CBCT (Cone Beam Computed Tomography) imaging before treatment. Participants will then be randomly assigned into one of two groups. The first group will use AI-assisted planning software that automatically helps identify important anatomical structures, detects missing teeth, and assists in planning the ideal implant position. The second group will use a conventional digital planning method performed manually by the clinician using standard software.
For both groups, a customized surgical guide will be designed and fabricated using 3D-printing technology. During surgery, the guide will help the surgeon place the dental implants in the planned position with high precision. After implant placement, patients will receive routine postoperative care and follow-up. A healing period of approximately three months will be allowed before placement of the final crown or bridge restoration.
To evaluate the accuracy of the procedure, postoperative CBCT scans will be compared with the original virtual treatment plan. The study will measure any differences between the planned and actual implant positions, including implant depth, angle, and overall positioning.
The study aims to determine whether AI-assisted implant planning can improve the precision, efficiency, and predictability of guided implant surgery compared with conventional digital planning methods. The results may contribute to improving future dental implant treatment and digital surgical workflows.
Participation in this study is voluntary, and all patient information will remain confidential. Possible risks are similar to those associated with standard dental implant surgery and may include pain, swelling, bleeding, infection, temporary numbness, or implant failure. Patients will be closely monitored throughout treatment, and any complications will be managed by the research team.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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New Cairo
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Cairo, New Cairo, Egipto, 11835
- Future University in Egypt
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Patients who are partially or completely edentulous.
- Patient aged 21 to 60 years old
- A willingness to cooperate with study protocol and follow-up program
Exclusion Criteria:
- Medical contraindications to dental treatment.
- Uncontrolled periodontal disease that interfere with healing.
- Cancer Patient (under radiation / chemotherapy).
- Present of any acute local infection.
- Uncontrolled diabetic patient.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Group A: AI-assisted computer-guided implant planning
The surgical guide will be utilized using Bluesky bio software and Perfactory Micro 3D printing machine.
The BlueSky software using AI automatically detects the nerves, detects the missing teeth, and places the dental implant and fabricate the surgical stent.
The stent is then exported to STL file and printed.
It will be positioned on the mandible or the maxilla.
The implants will be inserted into the mandible or the maxilla under the guidance of the surgical guide.
|
The surgical guide will be utilized using Bluesky bio software and Perfactory Micro 3D printing machine.
The BlueSky software using AI automatically detects the nerves, detects the missing teeth, and places the dental implant and fabricate the surgical stent.
The stent is then exported to STL file and printed.
It will be positioned on the mandible or the maxilla.
The implants will be inserted into the mandible or the maxilla under the guidance of the surgical guide CBCT will be taken post-operatively for the patient with the implants in place.
The pre-operative and postoperative CBCT plan will be superimposed virtually and any deviations in implant depth or angulations in different planes different from the plan will be recorded.
|
|
Comparador activo: Group B: Conventional computer-guided implant planning
The surgical guide will be created utilizing PlastyCAD Software and Perfactory Micro 3D printing machine.
It will be positioned on the mandible or the maxilla.
The implants will be inserted into the mandible or the maxilla under the guidance of the surgical guide.
This procedure will be performed on both completely edentulous and partially edentulous patients.
|
The surgical guide will be created utilizing PlastyCAD Software and Perfactory Micro 3D printing machine. It will be positioned on the mandible or the maxilla. The implants will be inserted into the mandible or the maxilla under the guidance of the surgical guide. This procedure will be performed on both completely edentulous and partially edentulous patients. CBCT will be taken post-operatively for the patient with the implants in place. The pre-operative and postoperative CBCT plan will be superimposed virtually and any deviations in implant depth or angulations in different planes different from the plan will be recorded. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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implant angular deviation and implant depth
Periodo de tiempo: From enrollment to the end of treatment at 12 weeks
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CBCT will be taken post-operatively for the patient with the implants in place.
The pre-operative and postoperative CBCT plan will be superimposed virtually and any deviations in implant depth or angulations in different planes different from the plan will be recorded.
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From enrollment to the end of treatment at 12 weeks
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
- FUE.REC(42)/12-2023
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
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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