- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03417375
Assessment of the Quality and Quantity of Bone Regeneration
Assessment of the Quality and Quantity of Bone Regeneration in the Maxillary Sinus Using Osteocel With Scaffold or Allograft Materials: A Radiographic and Histomorphometric Randomized Controlled Clinical Study.
The purpose of this study is to histologically and radiographically evaluate the maxillary sinus bone volume and density, with reference to percentage of vital bone present, after four months of grafting with either Osteocel or a cortical-cancellous allograft.
- To assess the quality and quantity of the maxillary sinus bone prior to the placement of dental implants and subsequent restorations, approximately 20 patients will be randomly assigned to receive an augmentation of the maxillary sinus region using either Osteocel or a cortical-cancellous allograft.
- With the use of pre-operative and four months post-operative CBCT radiography, the maxillary sinus bone density will be assessed and compared between the individuals receiving Osteocel and the individuals receiving conventional cortical-cancellous allograft material.
- Histomorphometric analysis will be used to assess, compare and contrast the quality and the quantity of the new vital bone cells generated when using these different graft materials
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Eligible patients will be randomly assigned into one of two treatment groups using a randomization table generated by a computer. The test group (10 sinuses) will receive Osteocel Plus and control group (10 sinuses) will receive conventional cortical-cancellous particulate allograft material. The objective of this research is to serve as a pilot study, gathering information that will guide the design of a larger subsequent study. Little is known about the distribution of bone quality changes in patients who receive Osteocel Plus graft to augment the maxillary sinus. Ten subjects per group is reasonable for a pilot study, providing an 89% probability of estimating the true mean for bone quality and implant stability to within half a standard deviation in each group. These means, along with the observed standard deviations and within-subject correlations that the investigators obtain will prove essential for designing the larger, confirmatory study that constitute the next phase of this research.
A clinical radiographic/surgical guide will be fabricated for each patient to be used for CBCT scan prior to sinus augmentation procedure. The same clinical radiographic/surgical guide will be used for CBCT scan prior to the implant placement to measure the amount of bone regeneration following four months of healing at the exact sites. One line will measure the horizontal width and the other line will measure the vertical height. The horizontal width will be measured at a vertical height of 10 mm from the sinus floor in the sinus cavity based on the conventional average length of dental implant used in implant dentistry. The difference in the measurements for all surgical sites after the grafting procedure and before the implant placement will provide a clinical assessment of the amount of bone regeneration.
Forty trephined core samples will be retrieved surgically from two areas of the grafted lateral window at the time of implant placement. One core sample will be retrieved from the anterior area, approximately 4 mm distal to the anterior tack which was used to fix the resorbable membrane, and the other one will be retrieved from the posterior area, approximately 4 mm mesial of the posterior tack which was used to fix the resorbable membrane. Histomorphometric analysis will be performed on three fields for each section using specialized software. Volume of vital bone, graft remnants, and connective tissue will be measured based on the averages of the percentages at a magnification of 63X. Data will be statistically analyzed using Statistical Package for the Social Sciences (SPSS 13.0 for Windows software) program to compare between test and control groups.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40536
- University of Kentucky College of Dentistry
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
Must be 22 years old or older. Must have at least one edentulous posterior site requiring grafting. Must have an implant restoration to replace at least one tooth in the edentulous site.
Must be available for the follow-up examinations.
Exclusion Criteria:
Current smokers Dental infections of bone Untreated periodontal disease Pregnant patients or those who are nursing Uncontrolled diabetes (via patient reported A1C) Chemotherapy/Radiation patients Autoimmune diseases Kidney disease Liver disease
Plan de estudios
¿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 |
---|---|
Experimental: Osteocel Plus
Experimental product will be placed in one sinus while the control product will be placed in the contralateral sinus.
(Randomized)
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Lateral window sinus augmentation with core samples harvested from the window following 4 months of healing.
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Comparador activo: alloOss
The control product will be placed in one sinus while the control product will be placed in the contralateral sinus.
(Randomized)
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Lateral window sinus augmentation with core samples harvested from the window following 4 months of healing.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Quality of Bone Regeneration (Number of Osteoblasts per histologic section)
Periodo de tiempo: 4 months post-operative of sinus augmentation.
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Core samples of bone will be evaluated histomorphometrically for number of osteoblasts present.
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4 months post-operative of sinus augmentation.
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Quantity of Bone Regeneration (Linear measurements)
Periodo de tiempo: 3.5 months post-operative of sinus augmentation.
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Linear measurement of HEIGHT of bone gain
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3.5 months post-operative of sinus augmentation.
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Quantity of Bone Regeneration (Linear measurements)
Periodo de tiempo: 3.5 months post-operative of sinus augmentation.
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Linear measurement of WIDTH of bone gain
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3.5 months post-operative of sinus augmentation.
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Quantity of Bone Regeneration (Linear measurements)
Periodo de tiempo: 3.5 months post-operative of sinus augmentation.
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Linear measurement of DEPTH of bone gain
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3.5 months post-operative of sinus augmentation.
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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
Otros números de identificación del estudio
- 17-0102-F2L
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.
producto fabricado y exportado desde los EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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