Guided Bone Regeneration Combined With PRGF for Atrophic Edentulous Maxilla (GBR-PRGF-Maxil)
Guided Bone Regeneration Combined With Plasma Rich in Growth Factors for Vertical and Horizontal Augmentation of the Atrophic Edentulous Maxilla: A Prospective Clinical Case Series With One-Year Follow-up
This prospective interventional clinical study evaluated guided bone regeneration combined with plasma rich in growth factors for vertical and horizontal augmentation of the atrophic edentulous maxilla.
Participants with severe maxillary ridge atrophy requiring bone augmentation before implant-supported rehabilitation underwent guided bone regeneration using a composite graft of autogenous bone and anorganic bovine bone mineral combined with plasma rich in growth factors. Barrier membranes were stabilised with titanium pins, and lateral-window sinus floor elevation was performed when indicated. Implants were placed using a delayed protocol at re-entry after 6-9 months.
Radiographic bone height and width were assessed by cone-beam computed tomography before surgery, immediately after surgery, at 6-9 months, and at 12 months. The study also recorded graft dimensional stability, implant placement, and surgical or postoperative complications.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Severe atrophy of the edentulous maxilla may limit fixed implant-supported rehabilitation because of insufficient residual alveolar ridge height and width. Guided bone regeneration is used to reconstruct deficient ridges before implant placement, while plasma rich in growth factors may provide an autologous fibrin matrix enriched with platelet-derived mediators.
This prospective clinical study assessed a guided bone regeneration protocol combined with plasma rich in growth factors for reconstruction of the atrophic edentulous maxilla. Eligible participants presented with an edentulous atrophic maxilla requiring vertical and/or horizontal ridge augmentation before implant placement. The surgical protocol included guided bone regeneration using a composite graft of autogenous bone and anorganic bovine bone mineral in a 60:40 ratio, combined with plasma rich in growth factors prepared from autologous blood. The grafted area was covered with a barrier membrane stabilised with titanium pins. Titanium-reinforced PTFE membranes were used for defects requiring vertical space maintenance, while collagen membranes were used for horizontal augmentations. Lateral-window sinus floor elevation was performed simultaneously when indicated by posterior maxillary anatomy.
Cone-beam computed tomography was obtained pre-surgically, immediately post-operatively, at 6-9 months, and at 12 months. Linear vertical and horizontal bone measurements were performed at three standardised maxillary reference sites: the lateral wall of the nasal cavity, the medial wall of the maxillary sinus, and the zygomatic apophysis. Bone gain was calculated in millimetres and as percentage change relative to the pre-surgical dimension. Graft resorption was calculated between the immediate post-operative and 12-month assessments. Implant placement and intraoperative or postoperative complications were also recorded.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Porto, Portugal
- Faculty of Dental Medicine, university of Porto
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age 18 years or older
- Fully edentulous maxilla requiring implant-supported fixed oral rehabilitation
- Atrophic maxillary alveolar ridge requiring vertical and/or horizontal bone augmentation before implant placement
- Residual alveolar ridge width below 6 mm and/or residual bone height below 10 mm, as assessed by cone-beam computed tomography
- ASA physical status I or II
- Clinical indication for guided bone regeneration, with or without simultaneous maxillary sinus floor elevation
- Adequate oral hygiene and willingness to comply with postoperative instructions and follow-up visits
- Written informed consent provided.
Exclusion Criteria:
- ASA physical status III or higher
- Uncontrolled systemic disease contraindicating oral surgery or bone regenerative procedures
- Uncontrolled diabetes mellitus or other systemic condition expected to impair wound healing or bone regeneration
- History of radiotherapy to the head and neck region
- Current or previous intravenous antiresorptive or antiangiogenic therapy associated with risk of medication-related osteonecrosis of the jaw
- Active oral infection at the surgical site
- Untreated periodontal disease or poor oral hygiene incompatible with regenerative surgery
- Heavy smoking or unwillingness to comply with perioperative smoking restrictions
- Pregnancy or breastfeeding
- Inability to understand the study procedures or provide informed consent
- Inability or unwillingness to attend scheduled follow-up visits
- Any medical, anatomical, or behavioural condition judged by the investigator to interfere with surgery, healing, follow-up, or interpretation of outcomes
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: GBR Combined With PRGF
Participants with an atrophic edentulous maxilla requiring vertical and/or horizontal bone augmentation before implant-supported rehabilitation underwent guided bone regeneration combined with plasma rich in growth factors.
The procedure used a composite graft of autogenous bone and anorganic bovine bone mineral combined with PRGF.
Barrier membranes were stabilised with titanium pins, and simultaneous lateral-window sinus floor elevation was performed when clinically indicated.
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Guided bone regeneration was performed for reconstruction of the atrophic edentulous maxilla.
Autogenous bone harvested intra-orally was combined with anorganic bovine bone mineral in a 60:40 ratio and mixed with autologous plasma rich in growth factors.
The grafted area was covered with a barrier membrane stabilised with titanium pins.
Titanium-reinforced PTFE membranes were used for defects requiring vertical space maintenance, while collagen membranes were used for horizontal augmentations.
Lateral-window sinus floor elevation was performed simultaneously when indicated.
Implants were placed using a delayed protocol at re-entry after 6-9 months.
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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Change in Vertical and Horizontal Maxillary Bone Dimensions
Periodo de tiempo: Pre-surgery, immediately post-operative, 6-9 months, and 12 months
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Vertical and horizontal bone dimensions were measured using standardized cone-beam computed tomography at three maxillary reference sites: the lateral wall of the nasal cavity, the medial wall of the maxillary sinus, and the zygomatic apophysis.
Bone gain was calculated in millimeters and as percentage change relative to the pre-surgical dimension.
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Pre-surgery, immediately post-operative, 6-9 months, and 12 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Graft Resorption
Periodo de tiempo: Immediately post-operative to 12 months
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Graft resorption was calculated as the percentage change in vertical and horizontal bone dimensions between the immediate post-operative CBCT and the 12-month CBCT assessment.
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Immediately post-operative to 12 months
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Number of Dental Implants Placed
Periodo de tiempo: 6-9 months after augmentation
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Number of dental implants placed during delayed implant placement at re-entry following guided bone regeneration.
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6-9 months after augmentation
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Incidence of Surgical and Postoperative Complications
Periodo de tiempo: From augmentation surgery to 12 months
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Intraoperative and postoperative complications were recorded, including infection, graft loss, membrane-related complications, and other adverse events.
Complications were classified according to severity and whether they affected graft integrity.
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From augmentation surgery to 12 months
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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
Términos MeSH relevantes adicionales
- Resorción ósea
- Enfermedades óseas
- Enfermedades musculoesqueléticas
- Atrofia periodontal
- Enfermedades periodontales
- Enfermedades de la Boca
- Enfermedades Estomatognáticas
- Enfermedades de la mandíbula
- Enfermedades maxilares
- Pérdida ósea alveolar
- Maxilar atrófico
- Péptidos
- Aminoácidos, péptidos y proteínas
- Proteínas
- Procedimientos quirúrgicos, operativo
- Factores biológicos
- Odontología
- Procedimientos quirúrgicos orales
- Procedimientos quirúrgicos orales, preprotésicos
- Péptidos de señalización intercelular y proteínas
- Alveolar Ridge Augmentation
Otros números de identificación del estudio
- 5/2022 FMDUP-PRGF
- 5/2022 (Otro identificador: Ethics Committee for Health of the Faculty of Dental Medicine, U. Porto)
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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