- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07932418
Assessment of the Oblique Sandwich Osteotomy for Augmentation of Posterior Atrophic Mandible
Rehabilitation of the partially or totally edentulous mandible with implant supported prosthesis has become a common practice in the last few decades. Local conditions of the edentulous ridges may be unfavorable for dental implant placement, where sufficient bony support in both the horizontal and vertical dimensions is the foundation of any successful oral rehabilitation with dental implants.
Challenges include the resorpative changes of the alveolar ridge after tooth extractions and the hard tissue deficits due to chronic periodontal disease or congenitally missing teeth. Neoplasm, osteomyelitis, cysts or trauma can also compromise the situation. All these factors require the oral implantologist to create using regenerative techniques sufficient hard tissue support at the appropriate site before or during dental implant installation.
Multiple bone grafting materials and techniques have been used to reconstruct the partially dentate and edentulous posterior mandibular ridges with high rates of success, these techniques include block onlay grafting technique, guided bone regeneration using membranes or meshes and distraction osteogenesis. The selection of the optimal technique depends on various factors, including the degree of the defect, the grafted bone substitute available, the medical condition of the patient and also the skill and experience of the operator.
The aim of this study is to evaluate the alveolar bone volume by the CBCT after performing oblique sandwich osteotomy in conjunction with interpositional autogenous bone grafting in the atrophied posterior mandible.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Rehabilitation of the partially or totally edentulous mandible with implant supported prosthesis has become a common practice in the last few decades. Local conditions of the edentulous ridges may be unfavorable for dental implant placement, where sufficient bony support in both the horizontal and vertical dimensions is the foundation of any successful oral rehabilitation with dental implants.
Challenges include the resorpative changes of the alveolar ridge after tooth extractions and the hard tissue deficits due to chronic periodontal disease or congenitally missing teeth. Neoplasm, osteomyelitis, cysts or trauma can also compromise the situation. All these factors require the oral implantologist to create using regenerative techniques sufficient hard tissue support at the appropriate site before or during dental implant installation.
Multiple bone grafting materials and techniques have been used to reconstruct the partially dentate and edentulous posterior mandibular ridges with high rates of success, these techniques include block onlay grafting technique, guided bone regeneration using membranes or meshes and distraction osteogenesis. The selection of the optimal technique depends on various factors, including the degree of the defect, the grafted bone substitute available, the medical condition of the patient and also the skill and experience of the operator.
The aim of this study is to evaluate the alveolar bone volume by the CBCT after performing oblique sandwich osteotomy in conjunction with interpositional autogenous bone grafting in the atrophied posterior mandible.
In this study ten atrophied posterior mandibular regions will be augmented with autogenous interpositional particulate bone harvested from the ipsilateral retromolar area through the oblique sandwich osteotomy procedure. The mobilized segment will be stabilized by using 2.0 manipulates and screws. The graft is then covered by platelet rich fibrin membrane.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: nehal Shobair lecturer, PhD
- Номер телефона: 010171181794
- Электронная почта: nehalshobair@dent.asu.edu.eg
Места учебы
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Cairo, Египет
- Рекрутинг
- Faculty of Dentistry Ain Shams Univeristy
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Контакт:
- nehal Shobair lecturer, Phd
- Электронная почта: nehalshobair@dent.asu.edu.eg
-
Контакт:
- Номер телефона: +201017181749
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Partially edentulous patients with moderate to severe posterior atrophic mandibular ridges,
- Sufficient alveolar bone width for implant placement (at least 7 mms),
- A native alveolar bone height above the mandibular alveolar canal till the alveolar crest (measuring from 5 to 9 mms),
- Adequate inter-arch space,
- The site of the graft is free from any pathologic lesion as cyst, infection or tumor.
Exclusion Criteria:
- The patients suffering from any systemic and metabolic disease that may affect normal healing of bone and soft tissue as diabetes or osteoporosis
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Активный компаратор: oblique sandwich osteotomy augmenation
atrophic posterior mandibular regions wiil be augmented with autogenous interpositional particulate bone harvested from the ipsilateral retromolar area through the oblique sandwich osteotomy procedure. The mobilized segment will be stabilized by using 2.0 manipulates and screws. The graft is then covered by platelet rich fibrin membrane. |
atrophic posterior mandibular regions is augmented with autogenous interpositional particulate bone harvested from the ipsilateral retromolar area through the oblique sandwich osteotomy procedure. The mobilized segment is stabilized by using 2.0 manipulates and screws. The graft is then covered by platelet rich fibrin membrane. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Clinical evaluation
Временное ограничение: 4 months
|
clinical evalauation of the occurrence of any complications after augmentation involving wound dehiscence, infection, neuro-sensory disturbance and for the stability of the augmented alveolar ridges |
4 months
|
|
Radiographic evaluation
Временное ограничение: 4 months
|
Linear and volumetric Measurements to calculate first the post-operative CBCT bone volume then the volume of the plate is calculated separately and subtracted from the postoperative volume. The preoperative and postoperative CBCTs and the difference in volume is calculated through subtraction of postoperative and preoperative results |
4 months
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- 1415
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .