- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07664605
Outcomes of Ridge Splitting Versus Sausage Technique
Outcomes Of Ridge Splitting Versus Sausage Technique With Simultaneous Implant Placement For Augmenting Mandibular Horizontal Bone Defects.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Several bone augmentation approaches address horizontal bone resorption to achieve successful implantation including bone block grafting, guided bone regeneration (GBR), sinus augmentation and alveolar ridge split , However, bone block grafting had disadvantages like donor site morbidity and longer treatment time,GBR had the risk of infection due to exposure membrane and collapse of the regeneration membrane (1)These drawbacks may eventually lead to implant failure Alternatively, the Alveolar ridge splitting technique may solve some barriers and create proper dimensions for delayed or immediate implantation in both maxillary and mandible.(2) The alveolar ridge splitting technique was introduced by Simion in 1992 as a successful bone grafting technique to augment the horizontally deficient alveolar ridge with immediate implant placement. (3)The main disadvantage of the conventional ridge splitting technique is the high risk of bad split, fractures or even fenestrations of the buccal cortical plate of bone during separation with massive crestal bone loss surrounding the implants.(4)Therefore, a lot of clinical trials were introduced using minimally invasive protocols dealing with such complications for example, the usage of piezoelectric surgery or using surgical guides.(5)
In the past, onlay grafts of bone harvested from the hip, maxillary tuberosity, symphysis of the chin, or external oblique ridge have all been used with success in reconstruction of atrophic ridges,onlay grafts often require a healing period of 6 months to a year before dental implants can be placed, and the onlay graft sometimes fails to fuse to the augmented site. (6)The segmental ridge-split procedure provides a quicker method where in an atrophic ridge can be predictably expanded and grafted with bone allograft, eliminating the need for a second surgical site.(7) Using of piezoelectric alveolar ridge splitting (ARS) with simultaneous implant placement will enhance implant stability in comparison with conventional motorized surgical disc and bur .(8) Piezosurgery enhanced implant stability but didn,t mitigate the bone loss associated with ARS or increase amount of ridge width gain.(9)
The piezosurgery can be a safer option in maintaining the vitality of bone and piezoelectric implant site drilling protocol seemed to be a reliable and repeatable technique. (10) Preparation of the implant bed with the aid of piezoelectric inserts showed improved implant stability with a 100% success rate .(11) Extensive alveolar bone augmentation using sausage technique achieved significant horizontal or vertical bone height or width increase, and the retention rate after 6 months was also high,In addition, surgery in the maxillary region showed a more successful bone augmentation than in the mandible, with a higher maintenance rate. (12)The concept of GBR uses graft materials as a scaffold to preserve the created space and a non-resorbable or resorbable membrane to exclude the growth of epithelium and connective tissue cells inward the defect. (13) Urban and colleagues proposed an improved technique to stabilize the graft material to the crest by modifying the collagen membrane fixation method and the original sausage technique combines autograft chips with an organic bovine bone mineral (ABBM) particles to provide the graft mixture with osteogenic properties.(14) Briefly, the technique is similar to conventional GBR in that the membrane is fixed with pins, However, the graft material is filled inside the fixed membrane in a sufficient quantity to show a balloon effect and to push the graft material in the crestal direction to create tension on the membrane ,In this technique, two types of collagen membranes can be used: a crosslinked synthetic collagen membrane or a native collagen membrane.(15)
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: ahmed alghandour, phd
- Número de teléfono: 002 01224567435
- Correo electrónico: ahmed.nagi@dent.bsu.eg
Ubicaciones de estudio
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Cairo, Egipto
- Reclutamiento
- Beni-Suef University
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Contacto:
- ahmed alghandour, phd
- Número de teléfono: 002 002012457435
- Correo electrónico: dr.ahmnagi@yahoo.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Patients with deficient bone volume between (2 : 3.5 ) mm
- Patients must have installed functional implant for no less than 3 months- enough time to allow for bone augmentation changes.
- Patients with no defect in the gingival tissues.
- Patients with un-remarkable medical compromising conditions
- Patients with good oral hygiene at time of the examination
Exclusion Criteria:
- Patients with compromising medical condition.
- Patients with severe bone resorption.
- Patients with D1 or D2 bone.
- Bone height <10mm
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Ridge split
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The alveolar ridge splitting technique was introduced by Simion in 1992 as a successful bone grafting technique to augment the horizontally deficient alveolar ridge with immediate implant placement
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Comparador activo: Sausage techinque
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The alveolar ridge splitting technique was introduced by Simion in 1992 as a successful bone grafting technique to augment the horizontally deficient alveolar ridge with immediate implant placement
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Evaluation of bone width
Periodo de tiempo: (4-6) months
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Cone beam CT used to asses bone density
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(4-6) months
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Implant primary stability
Periodo de tiempo: (4-6 )months
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Osstel device used to asses the stability from 1 to 100
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(4-6 )months
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Lin Y, Li G, Xu T, Zhou X, Luo F. The efficacy of alveolar ridge split on implants: a systematic review and meta-analysis. BMC Oral Health. 2023 Nov 20;23(1):894. doi: 10.1186/s12903-023-03643-2.
- Hamzah B, Mounir R, Ali S, Mounir M. Maxillary horizontal alveolar ridge augmentation using computer guided ridge splitting with simultaneous implant placement versus conventional technique: A randomized clinical trial. Clin Implant Dent Relat Res. 2021 Aug;23(4):555-561. doi: 10.1111/cid.13015. Epub 2021 Jun 8.
- Arakji H, Osman E, Aboelsaad N, Shokry M. Evaluation of implant site preparation with piezosurgery versus conventional drills in terms of operation time, implant stability and bone density (randomized controlled clinical trial- split mouth design). BMC Oral Health. 2022 Dec 3;22(1):567. doi: 10.1186/s12903-022-02613-4.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 25230
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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