3D-Printed PLA Guide Versus Resin Guide in Mandibular Molar Implant Placement (CGIIPMM-PLA-MR)
12 de septiembre de 2026 actualizado por: Mohamed Esmail Ahmed Hassan
Computer Guided Immediate Implant Placement in Mandibular Molars Using Patient Specific 3D Printed Polylactic Acid Guide Versus Modified Resin Guide
This randomized clinical trial compares two tooth-supported computer-guided surgical guide systems for immediate implant placement in mandibular molar extraction sockets: a patient-specific 3D-printed PLA guide system and a modified resin guide system.
The study evaluates implant positioning accuracy, primary implant stability, and surgical time.
Descripción general del estudio
Estado
Terminado
Descripción detallada
This randomized clinical trial compares two tooth-supported computer-guided surgical guide systems for immediate implant placement in mandibular molar extraction sockets: a patient-specific 3D-printed polylactic acid (PLA) guide system and a modified resin guide system. Preoperative CBCT and digital intraoral scans were used for prosthetically driven virtual implant planning and fabrication of the surgical guides.
Implant positioning accuracy was assessed by comparing the planned and actual implant positions using preoperative and postoperative CBCT datasets. Angular deviation, coronal deviation at the implant platform, and apical deviation were recorded.
Primary implant stability was assessed immediately after implant placement using Implant Stability Quotient (ISQ) measurements obtained with an Osstell device. Surgical time was recorded from seating of the surgical guide and initiation of osteotomy until completion of implant insertion.
The study was designed to compare the performance of the two guide systems in immediate mandibular molar implant placement.
Tipo de estudio
Intervencionista
Inscripción (Actual)
20
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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New Cairo
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Cairo, New Cairo, Egipto, 11511
- Future University in Egypt (FUE)
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Age 20-50 years.
- Non-restorable mandibular first molar indicated for extraction.
- Sufficient bony support for implant placement without the need for significant bone augmentation.
- Good oral hygiene and motivation.
- Adequate prosthetic space.
- Ability and willingness to undergo the surgical procedure and follow-up.
- Suitable for computer-guided, tooth-supported implant placement.
Exclusion Criteria:
- Uncontrolled systemic diseases that may impair healing (e.g., uncontrolled diabetes or hypertension).
- Severe periodontal disease.
- Patients undergoing chemotherapy or radiotherapy.
- Insufficient prosthetic space.
- Heavy smokers.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: patient specific 3d printed PLA guide
Immediate implant placement in mandibular molar extraction sockets using a patient-specific tooth-supported 3D-printed PLA surgical guide system.
Preoperative CBCT and digital intraoral scans were used for prosthetically driven virtual implant planning and guide fabrication.
The guide was fabricated from PLA according to the planned implant position.
Following atraumatic tooth extraction and socket preparation, the guide was seated and osteotomy preparation was performed through the guide's guiding channel according to the planned trajectory, followed by immediate implant insertion.
Primary implant stability was assessed using an Osstell device and Implant Stability Quotient (ISQ) measurements.
|
Preoperative virtual planning was performed using CBCT data and digital intraoral scans.
The datasets were used for prosthetically driven implant planning and fabrication of a patient-specific 3D-printed PLA surgical guide.
Following atraumatic tooth extraction and socket preparation, the guide was seated and osteotomy preparation was performed through the guiding channel according to the planned implant position and trajectory.
The implant was then immediately inserted.
Primary implant stability was assessed using an Osstell device and Implant Stability Quotient (ISQ) measurements.
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Comparador activo: Modified Resin guide
Immediate implant placement in mandibular molar extraction sockets using a tooth-supported modified resin surgical guide system.
Preoperative CBCT and digital intraoral scans were used for prosthetically driven virtual implant planning and guide fabrication.
The guide was fabricated from light-cured surgical-guide resin according to the planned implant position.
Following atraumatic tooth extraction and socket preparation, the guide was seated and osteotomy preparation was performed through the guide's guiding channel according to the planned trajectory, followed by immediate implant insertion.
Primary implant stability was assessed using an Osstell device and Implant Stability Quotient (ISQ) measurements.
|
Preoperative virtual planning was performed using CBCT data and digital intraoral scans.
The datasets were used for prosthetically driven implant planning and fabrication of a tooth-supported modified resin surgical guide.
Following atraumatic tooth extraction and socket preparation, the guide was seated and osteotomy preparation was performed through the guiding channel according to the planned implant position and trajectory.
The implant was then immediately inserted.
Primary implant stability was assessed using an Osstell device and Implant Stability Quotient (ISQ) measurements.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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accuracy of implant position
Periodo de tiempo: Assessed within 1 week postoperatively, following acquisition of the postoperative CBCT scan.
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Accuracy of implant placement will be evaluated by comparing the planned implant position from the preoperative digital plan with the actual implant position obtained from the postoperative CBCT scan.
Deviations will be assessed in three dimensions, including angular deviation (degrees), coronal deviation (platform) (mm), and apical deviation (mm).
Measurements will be performed using specialized implant-planning software by superimposing the preoperative and postoperative datasets.
Lower deviation values indicate greater agreement between the planned and actual implant positions.
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Assessed within 1 week postoperatively, following acquisition of the postoperative CBCT scan.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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primary implant stability by osstell
Periodo de tiempo: Measured immediately at the time of implant placement during the surgical procedure.
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Primary implant stability will be assessed using an Osstell device, which measures Implant Stability Quotient (ISQ) values through resonance frequency analysis.
A SmartPeg will be attached to the implant, and ISQ readings will be taken in two perpendicular directions (buccolingual and mesiodistal).
Higher ISQ values indicate greater mechanical stability.
The mean ISQ value for each implant will be recorded and used for analysis
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Measured immediately at the time of implant placement during the surgical procedure.
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surgical time
Periodo de tiempo: Assessed intraoperatively, measured during the surgical appointment, and recorded immediately after surgery
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Surgical time will be recorded to evaluate the procedural efficiency of guided immediate implant placement.
Time will be measured from seating of the surgical guide and initiation of osteotomy until completion of implant insertion.
The total duration will be recorded in minutes.
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Assessed intraoperatively, measured during the surgical appointment, and recorded immediately after surgery
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Shi Y, Wang J, Ma C, Shen J, Dong X, Lin D. A systematic review of the accuracy of digital surgical guides for dental implantation. Int J Implant Dent. 2023 Oct 25;9(1):38. doi: 10.1186/s40729-023-00507-w.
- Ragucci GM, Elnayef B, Criado-Camara E, Del Amo FS, Hernandez-Alfaro F. Immediate implant placement in molar extraction sockets: a systematic review and meta-analysis. Int J Implant Dent. 2020 Oct 13;6(1):40. doi: 10.1186/s40729-020-00235-5.
- Ku JK, Lee J, Lee HJ, Yun PY, Kim YK. Accuracy of dental implant placement with computer-guided surgery: a retrospective cohort study. BMC Oral Health. 2022 Jan 16;22(1):8. doi: 10.1186/s12903-022-02046-z.
- Pieralli S, Spies BC, Hromadnik V, Nicic R, Beuer F, Wesemann C. How Accurate Is Oral Implant Installation Using Surgical Guides Printed from a Degradable and Steam-Sterilized Biopolymer? J Clin Med. 2020 Jul 22;9(8):2322. doi: 10.3390/jcm9082322.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
2 de noviembre de 2025
Finalización primaria (Actual)
10 de agosto de 2026
Finalización del estudio (Actual)
10 de septiembre de 2026
Fechas de registro del estudio
Enviado por primera vez
12 de septiembre de 2026
Primero enviado que cumplió con los criterios de control de calidad
12 de septiembre de 2026
Publicado por primera vez (Actual)
17 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
12 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- FUE.REC(78)/10-2025
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Individual participant data will not be shared because of participant privacy and confidentiality considerations.
Only aggregate study results will be reported.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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