- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07670559
Carrot Technique Versus Guided Bone Regeneration for Horizontal Ridge Deficiency in the Maxillary Esthetic Zone
Evaluation of the Carrot Technique With Simultaneous Implant Placement for Horizontal Alveolar Ridge Deficiency in the Maxillary Aesthetic Zone: A Randomized Controlled Clinical Trial.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
The Carrot Technique is a minimally invasive approach that utilizes an autogenous bone core harvested during implant osteotomy and repositioned to augment the deficient buccal ridge. This technique may reduce donor-site morbidity while providing sufficient horizontal bone augmentation. Guided Bone Regeneration remains one of the most widely used techniques for horizontal ridge reconstruction through the use of bone substitute materials and barrier membranes.
This randomized controlled clinical trial will compare the clinical and radiographic outcomes of the Carrot Technique and GBR in patients presenting with horizontal ridge deficiency in the maxillary esthetic zone. Twenty patients requiring single-tooth implant rehabilitation will be randomly allocated into two equal groups. Group I will receive implant placement combined with the Carrot Technique, while Group II will receive implant placement combined with Guided Bone Regeneration.
Clinical evaluations will include implant stability assessed by resonance frequency analysis, soft tissue healing using the Landry Healing Index, and peri-implant inflammation using the modified sulcus bleeding index. Radiographic evaluation will be performed using cone beam computed tomography immediately after surgery and at 6 and 12 months postoperatively to assess changes in alveolar ridge width, bone density, and marginal bone loss. The study aims to determine whether the Carrot Technique provides comparable or superior outcomes to GBR for horizontal ridge augmentation associated with implant placement.
Tipo de estudio
Inscripción (Estimado)
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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Dakahlia Governorate
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Al Mansurah, Dakahlia Governorate, Egipto, 35511
- 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:
- Patients aged 18 to 45 years. Missing a single tooth in the maxillary esthetic zone requiring implant placement.
Good oral hygiene and patient compliance. Medically free from systemic diseases that contraindicate implant surgery. Slight to moderate horizontal alveolar ridge deficiency with a minimum ridge width of 5 mm.
Adequate vertical bone height for implant placement. Medium to hard bone quality (D2-D3 according to Misch classification). Absence of bruxism or other parafunctional habits.
Exclusion Criteria:
- Presence of local pathological lesions (e.g., cysts or tumors) at the planned surgical site.
Poor bone quality (D4 bone). Pregnancy. Heavy smoking. Any medical condition contraindicating implant surgery.
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: Carrot Technique
Implant placement with horizontal ridge augmentation using an autogenous bone core harvested with a trephine drill from the implant osteotomy site and fixed buccally using osteosynthesis screws.
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Implant placement with simultaneous horizontal ridge augmentation using an autogenous bone core harvested from the implant osteotomy site with a trephine drill and fixed buccally using osteosynthesis screws.
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Comparador activo: Guided Bone Regeneration
Implant placement with horizontal ridge augmentation using bone substitute material and a collagen membrane according to guided bone regeneration principles.
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Implant placement with simultaneous horizontal ridge augmentation using bone substitute material and a collagen membrane according to guided bone regeneration principles.
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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 Alveolar Ridge Width
Periodo de tiempo: baseline and 12 Months
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Horizontal alveolar ridge width measured using cone beam computed tomography (CBCT).
Changes in ridge width will be calculated by comparing measurements obtained immediately after surgery and at follow-up.
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baseline and 12 Months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Marginal Bone Loss
Periodo de tiempo: 12 Months
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Marginal bone loss measured radiographically using CBCT using the implant as a reference.
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12 Months
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Soft Tissue Healing
Periodo de tiempo: 1 Week, 2 Weeks, and 1 Month
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Soft tissue healing assessed using the Landry Healing Index.
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1 Week, 2 Weeks, and 1 Month
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Modified Sulcus Bleeding Index
Periodo de tiempo: 1 Month and 12 Months
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Peri-implant soft tissue inflammation assessed using the Modified Sulcus Bleeding Index (mBI).
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1 Month and 12 Months
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Bone Density
Periodo de tiempo: 12 Months
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Buccal peri-implant bone density measured using CBCT and expressed in Hounsfield Units.
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12 Months
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Implant Stability Quotient (ISQ)
Periodo de tiempo: At implant placement and 12 months
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Implant stability assessed using resonance frequency analysis and expressed as Implant Stability Quotient (ISQ).
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At implant placement and 12 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sarah A Elmaghraby, Faculty of Dentistry, Mansoura University, Mansoura, Egypt
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Otros números de identificación del estudio
- R.26.02.103
Plan de datos de participantes individuales (IPD)
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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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