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Идёт набор NCT07419269

Comparison of Customized Allogenic Versus Autogenous Bone Block Graft for Alveolar Ridge Augmentation

Без фазы С лечением Alveolar Bone Loss

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Alveolar socket preservation with graft and flap surgery, allogenic bone block augmentation.
Кому может быть актуально
Состояния в реестре: Alveolar Bone Loss. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Австрия
Следующий шаг
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Обзор

The aim of this study is to determine whether jawbone augmentations using allogeneic and autogenous bone blocks lead to comparable three-dimensional clinical and radiological outcomes. In addition, the study seeks to investigate whether there are differences regarding safety, biocompatibility, complications, and PROMs. Furthermore, it aims to clarify whether differences exist between the two groups with respect to implant condition (one year after implantation and during annual follow-ups for up to five years).

Вмешательства

  • Процедура Alveolar socket preservation with graft and flap surgery
    Partially edentulous patients in need of implant therapy and presenting an insufficient bone volume (horizontal ridge width \<5mm) to allow placing a standard diameter implant defect-free in a prosthetically ideal position will be included. In the control group, the blocks will be adapted to the defect site morphology. With a small drill, holes for fixation will be prepared and the bone blocks will be immobilized with one or two screws. Subsequently, a layer of bone particles will be applied if
  • Процедура allogenic bone block augmentation
    Partially edentulous patients in need of implant therapy and presenting an insufficient bone volume (horizontal ridge width \<5mm) to allow placing a standard diameter implant defect-free in a prosthetically ideal position. Based on CT/CBCT scans of the patient, the allogenic bone block has already been virtually designed using 3D CAD/CAM technology prior to surgery. The individually milled bone graft Botiss maxgraft® bonebuilder (allogenic bone block), optional addition of MinerOss® A (alloge

Первичные конечные точки

  • ridge width gain in mm [Срок оценки: at screening after augementation (= day 0) 180 days past augmentation (=implantation) 1 year after 2nd stage surgery 2 years after 2nd stage surgery 3 years after 2nd stage surgery 4 years after 2nd stage surgery 5 years after 2nd stage surgery]

Критерии участия

Критерии включения

  • 1-4 missing teeth that need to be replaced with dental implants
  • Bone ridge width insufficient for dental implant placement; <5 mm of width as measured in a cone beam computed tomography at the ideal prosthetic position
  • Medically healthy with no known allergies to antibiotics
  • Non-smoker or light smoker (< 10) or previous smoker who had quit for 5 years or more
  • Periodontal health, as confirmed by clinical examination (Full mouth bleeding score and full mouth plaque score < 25%) and at least one neighboring natural tooth to the defect site(s)
  • Age of 18 or above

Критерии исключения

  • All contraindications against implant treatment or augmentative procedures (e.g., advanced systemic diseases, corticosteroid medication, immunodeficiency, pregnancy, intention to become pregnant, breastfeeding, lack of safe contraception)
  • Treatments or diseases that may have an effect on bone turnover or the bone itself or non-mineralized tissue metabolism (e.g., bisphosphonates or local radiotherapy, skeletal immaturity)
  • Pathological fractures such as those observed in (but not limited to) Paget's disease or in metastatic bone diseases
  • Any active malignancy or patient undergoing treatment for a malignancy Study protocol: IndiALLO Version 4/19.03.2025 Page 9 von 32
  • Contraindications to the class of drugs under study, e.g., known hypersensitivity or allergy to class of drugs or the investigational product
  • Persistent compartment syndrome or neurovascular residua of compartment syndrome

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Австрия · 1 центр
  • Department of Dental Medicine and Oral Health, Division of Oral Surgery and Orthodontics, — Graz

Идентификаторы

NCT: NCT07419269 · 36-016 ex 23/24 · 1638-2021

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗