Tooth-borne Interdental Distraction Osteogenesis Along Arch Curvature for Wide Alveolar Clefts Reduction (IDO)
A New Device for Interdental Distraction Osteogenesis for Management of Wide Alveolar Clefts
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Along the journey of treatment of cleft patients, secondary autogenous alveolar bone grafting is the technique basically used for cleft alveolus and palate repair during mixed dentition stage, in order to create bone support for teeth adjacent to the cleft, making a bone matrix through which teeth in the line of the cleft can erupt, re-stabilize alveolar process contour and maxillary segments. In cases with wide alveolar clefts, more than the width of a maxillary canine, failure of this procedure is usually encountered. So, a further step prior to grafting procedure can be done in an attempt to reduce cleft width to enhance success of future grafting.
Distraction osteogenesis (DO) which is a procedure of growing new bone by mechanical stretching of the ordinary pre-existing vascularized bone tissue by a distraction device, where both segments of new alveolar bone as well as attached gingiva are formed can be used here to aid in minimizing cleft width.
The aim of this study was to introduce a new custom-made tooth-borne distractor that could provide 3D control upon using interdental distraction osteogenesis (IDO) with a posterior segment transport anteriorly along curvature of the arch through creating a controlled fracture, then applying this distractor device carrying a bone transport segment forward, decreasing the cleft width anteriorly with another benefit of leaving behind regenerated bone and attached gingiva posteriorly.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Cairo, Egipto, 11566
- Department of Orthodontics, Faculty of Dentistry, Ain Shams University Cairo, Abbaseya, Egypt
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Patients with ages ranging from 12 to 25 years old
- Patients with repaired cleft lip and / or palate.
- Patients with wide alveolar clefts more than 6 mm.
- Patients with median facial clefts, absent premaxilla.
- Patients who had previous failed grafting.
Exclusion Criteria:
- Patients with contraindications to general anaesthesia and surgery.
- Patients with syndromic cleft lip and palate.
- Patients with very bad oral hygiene.
- Vulnerable groups.
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: Tooth borne interdental distraction along arch curvature appliance
Patients eligible to the study were prepared to receive interdental distraction osteogenesis.
The appliance was custom made for each patient.
It is made up of orthodontic bands, labial, palatal stainless steel 0.9mm arches and micro expander screw soldered to the first permanent molar and to the first premolar in the transport segment .
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This study aimed to provide a new design of a tooth-borne, custom-made distractor that could be easily constructed and rigid enough for controlled segment transport. After cases' selection, arch expansion was done first. Following expansion, preparation of the osteotomy site was done, through inducing root divergence at site of interdental osteotomy. Osteotomies were performed under general anesthesia using piezo-surgery, there were 2 osteotomies in a L-shape; interdental vertical osteotomy mesial to 1st molar and a horizontal one above apices of teeth in the transport segment. The distraction protocol was a latency period of 7 days, after which appliance activation started with a distraction rate of 0.4 mm/day with a rhythm of twice daily. Activation proceeded till teeth at the edge of the cleft came into contact. Then the appliance was fixed in place for a 3 months consolidation period.
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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Reduction of width of alveolar cleft and oronasal fistula
Periodo de tiempo: 2-3 months
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Reduction or even closure of the wide interdental alveolar defect and the oronasal fistula measured on CBCT radiograph
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2-3 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Dental changes with distraction
Periodo de tiempo: 2-3 months
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Amount of dental tipping that occurred with distraction forces measured on CBCT radiograph
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2-3 months
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Quality of distracted bone
Periodo de tiempo: 3-6 months
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Measurement of bone radio density in Hounsfield Unit from CBCT
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3-6 months
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Loss of anchorage with distraction forces
Periodo de tiempo: 2-3 months
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Amount of distal movement of anchor molar of the assembly as a side effect of the mesial distraction forces measured on CBCT radiograph
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2-3 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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- FDASU-RecM121715
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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