Comparison Between Xenograft and Extended PRF as Jumping Gap Grafting Material Versus Natural Healing of the Socket Without Any Material.
Clinical and Digital Evaluation of Different Jumping Gap Grafting Materials Versus No Grafting Material in Immediate Lower Molar Implant Placement
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Following atraumatic extraction and implant site preparation within the interradicular bone, the implant will be immediately inserted. A chairside customized healing abutment will then be fabricated to seal the extraction socket. According to group allocation, the jumping gap will be filled with xenograft, e-PRF, or left unfilled before placement of the customized healing abutment. Definitive prosthetic restoration will be delivered after three months of implant insertion.
Clinical Evaluation:
Implant stability will be assessed at implant placement and at 3 and 6 months using resonance frequency analysis with the Osstell device, with implant stability quotient (ISQ) values recorded.
Peri-implant soft-tissue health will be assessed using the modified sulcus bleeding index (mSBI) at 3 and 6 months intervals.
Digital Evaluation:
Peri-implant soft-tissue dimensional changes will be assessed using intraoral optical scans obtained preoperatively and at 1, 3, and 6 months. The resulting STL files will be superimposed using a best-fit alignment algorithm to evaluate dimensional changes in the peri-implant soft tissues.
- Radiographic Evaluation:
CBCT examinations will be obtained preoperatively, immediately after implant placement, and at 6 months. Three-dimensional superimposition of baseline and follow-up DICOM datasets will be used to evaluate hard-tissue dimensional changes.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Al Mansurah, Egipto
- Faculty of Dentistry, Mansoura University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Any partially dentate patients with non-restorable mandibular molar requiring dental extraction.
- Extraction sockets with intact bony walls and interradicular bone.
- Jumping gap more than 2mm.
Exclusion Criteria:
- Patients with any pathological lesion or aggressive periodontal disease at the planned surgical site impaired the immediate implant placement.
- Heavy smokers (≥ pack per day)
- Pregnancy.
- Patients with systemic diseases that absolutely contraindicate implant placement or para-functional habits (bruxism or clenching).
- Patients with poor oral hygiene or aggressive periodontal disease.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Ten immediate mandibular molar implant placement with xenograft filling materialof the jumping gap.
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after tooth extraction and implant placement, xenograft particulates were placed to fill the jumping gap before sealing the socket with a chairside socket sealing abutment.
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Experimental: Ten immediate mandibular molar implant placement with e-PRF filling material of the jumping gap.
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after tooth extraction and implant placement, e-PRF was prepared from the patient's collected blood and placed to fill the jumping gap before sealing the socket with a chairside socket sealing abutment.
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Sin intervención: Immediate mandibular molar implant placement without grafting material.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Linear and Volumetric Digital Evaluation of implant site
Periodo de tiempo: preoperative, 1 month, 3 months and 6 months postoperative.
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Peri-implant soft-tissue dimensional changes assessment using intraoral optical scans and resulting STL files superimposition using a best-fit alignment algorithm to evaluate dimensional changes in the peri-implant soft tissues.
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preoperative, 1 month, 3 months and 6 months postoperative.
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Radiographic Evaluation of Implant Site Volumetric Change
Periodo de tiempo: preoperatively, immediately after implant placement, and at 6 months
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CBCT examinations obtained and three-dimensional superimposition of baseline and follow-up DICOM datasets used to evaluate hard-tissue dimensional changes.
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preoperatively, immediately after implant placement, and at 6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Implant Stability
Periodo de tiempo: at implant placement, 3 months and 6 months postoperative.
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Implant stability assessment using resonance frequency analysis with the Osstell device to record implant stability quotient (ISQ) values.
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at implant placement, 3 months and 6 months postoperative.
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Modified Sulcus Bleeding Index
Periodo de tiempo: at 3 and 6 months postoperative.
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Evaluation of peri-implant soft-tissue health using the modified sulcus bleeding index (mSBI).
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at 3 and 6 months postoperative.
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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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- A01012024OS
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (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.
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