Alveolar Ridge Splitting With Simvastatin/PRF Composite and Simultaneous Implant Placement (ARS-SIMV)
Alveolar Ridge Splitting Augmented With Simvastatin/Platelet-Rich Fibrin Composite With Simultaneous Implant Placement in Horizontal Ridge Augmentation: A Randomized Controlled Clinical Trial
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Horizontal alveolar ridge deficiency frequently complicates implant placement following tooth loss. Alveolar ridge splitting is a well-established technique for horizontal ridge augmentation that allows simultaneous implant placement when sufficient vertical bone height is available. However, the predictability of bone regeneration may be influenced by the grafting material used.
Platelet-rich fibrin (PRF) is an autologous biomaterial rich in platelets, leukocytes, and growth factors that may enhance angiogenesis, soft tissue healing, and bone regeneration. Simvastatin has also demonstrated osteogenic and angiogenic properties through stimulation of bone morphogenetic protein-2 (BMP-2) expression and inhibition of osteoclastic activity. Combining simvastatin with PRF may further improve regenerative outcomes.
This single-center, randomized controlled clinical trial included 21 participants with horizontal alveolar ridge deficiency requiring implant-supported rehabilitation. Participants were randomly allocated into three equal groups (n = 7 per group). Group I underwent alveolar ridge splitting with simultaneous implant placement and augmentation using a xenogeneic bone graft. Group II received a xenogeneic bone graft blended with PRF. Group III received a xenogeneic bone graft blended with a simvastatin/PRF composite.
Clinical and radiographic evaluations were performed to assess horizontal bone gain, vertical bone gain, bone density using cone-beam computed tomography (CBCT), and keratinized tissue width. The study aimed to determine whether the addition of PRF alone or in combination with simvastatin could improve regenerative outcomes compared with conventional xenogeneic bone grafting.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Giza Governorate
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Cairo, Giza Governorate, Egipto
- Faculty of Oral and Dental Surgery, Misr University for Science and Technology
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
Horizontal alveolar ridge width of 3-5 mm. Vertical alveolar bone height of ≥11 mm. Edentulous site located in the mandibular anterior region. Absence of buccal bone undercuts. Male or female participants aged 18-50 years. Good general health and medically fit to undergo oral surgical procedures. Absence of periapical pathology at the intended implant site. Adequate crown height space to achieve a favorable crown-to-implant ratio. Willingness and ability to attend all scheduled follow-up visits. Provision of written informed consent.
Exclusion Criteria:
Uncontrolled systemic diseases (e.g., uncontrolled diabetes mellitus), active infection, bleeding disorders, or current anticoagulant therapy.
Severe systemic diseases (e.g., uncontrolled hypertension or severe cardiovascular disease).
Severe alveolar bone deficiencies not suitable for ridge splitting. Pregnancy or breastfeeding. Inability to comply with postoperative instructions or follow-up visits. Known allergy or hypersensitivity to simvastatin or study materials. Individuals from vulnerable populations unable to provide valid informed consent.
Bruxism or other parafunctional oral habits.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: control group
Participants underwent alveolar ridge splitting with simultaneous implant placement and augmentation using a xenogeneic bone graft.
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Surgical expansion of the horizontally deficient alveolar ridge followed by immediate dental implant placement.
Xenogeneic bone graft used to augment the expanded alveolar ridge around the implant.
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Experimental: PRF Group
Participants underwent alveolar ridge splitting with simultaneous implant placement and augmentation using a xenogeneic bone graft blended with platelet-rich fibrin (PRF).
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Surgical expansion of the horizontally deficient alveolar ridge followed by immediate dental implant placement.
Xenogeneic bone graft used to augment the expanded alveolar ridge around the implant.
Autologous platelet-rich fibrin prepared from the participant's blood and blended with the xenogeneic bone graft.
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Experimental: Simvastatin/PRF Group
Participants underwent alveolar ridge splitting with simultaneous implant placement and augmentation using a xenogeneic bone graft blended with a simvastatin/platelet-rich fibrin (PRF) composite.
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Surgical expansion of the horizontally deficient alveolar ridge followed by immediate dental implant placement.
Xenogeneic bone graft used to augment the expanded alveolar ridge around the implant.
Autologous platelet-rich fibrin prepared from the participant's blood and blended with the xenogeneic bone graft.
Locally applied simvastatin incorporated into the PRF/xenogeneic bone graft composite to enhance bone regeneration.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Horizontal Bone Gain
Periodo de tiempo: 6 months after surgery
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Horizontal bone gain was assessed by measuring the change in alveolar ridge width using cone-beam computed tomography (CBCT).
Measurements were obtained by superimposition of preoperative and 6-month postoperative CBCT scans at standardized reference levels.
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6 months after surgery
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Vertical Bone Gain
Periodo de tiempo: 6 months after surgery
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Vertical bone gain was assessed by comparing preoperative and 6-month postoperative CBCT scans using standardized reference points.
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6 months after surgery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Bone Density
Periodo de tiempo: 6 months after surgery
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Bone density of the augmented site was evaluated using CBCT gray scale values.
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6 months after surgery
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Keratinized Tissue Width
Periodo de tiempo: Baseline and 6 months after surgery
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Keratinized tissue width was measured clinically using a calibrated periodontal probe.
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Baseline and 6 months after surgery
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Implant Stability
Periodo de tiempo: Baseline (immediately after implant placement) and 6 months after surgery.
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Implant stability was assessed using the Implant Stability Test (IST) device.
Measurements were recorded as IST values immediately after implant placement and at the 6-month follow-up.
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Baseline (immediately after implant placement) and 6 months after surgery.
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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
- Enfermedades periodontales
- Enfermedades de la Boca
- Enfermedades Estomatognáticas
- Enfermedades de los dientes
- Pérdida de dientes
- Químicos orgánicos
- Hidrocarburos
- Hidrocarburos, cíclico
- Naftalenos
- Hidrocarburos aromáticos policíclicos
- Hidrocarburos, aromáticos
- Compuestos policíclicos
- Lovastatin
- Simvastatina
Otros números de identificación del estudio
- MUST-IRB-2024-0062
- 2024/0062 (Otro identificador: Misr University for Science and Technology Institutional Review Board (MUST-IRB))
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.
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