Bilateral Alveolar Cleft Reconstruction Using Double Iliac Bone Blocks vs Particulate Grafting

Официальное название

A Randomized Controlled Clinical Trial Comparing Double Iliac Corticocancellous Bone Blocks Versus Conventional Autogenous Particulate Bone Grafting for Bilateral Alveolar Cleft Reconstruction

Обзор

This study aims to compare the clinical outcomes of bilateral alveolar cleft reconstruction using double iliac corticocancellous bone block grafts versus conventional autogenous particulate bone grafting. The study will evaluate graft stability, bone volume, and postoperative complications in patients with bilateral alveolar clefts. Participants will be allocated into two groups, each receiving one of the two grafting techniques. Clinical and radiographic assessments will be performed during follow-up to determine the effectiveness and predictability of each method

Подробное описание

Alveolar cleft reconstruction is a critical component in the comprehensive management of patients with cleft lip and palate, aiming to restore alveolar continuity, facilitate tooth eruption, and provide support for the nasal base. Autogenous bone grafting remains the gold standard for alveolar cleft repair, with the iliac crest being the most commonly used donor site due to its rich cancellous bone content.

Conventional particulate cancellous bone grafting has been widely used with predictable outcomes; however, it may be associated with graft resorption and reduced structural stability, particularly in bilateral alveolar cleft cases. Recently, the use of corticocancellous bone block grafts has been proposed to enhance graft stability, maintain volume, and improve overall outcomes.

This study aims to compare double iliac corticocancellous bone block grafts with conventional autogenous particulate bone grafting in the reconstruction of bilateral alveolar clefts. Patients diagnosed with bilateral alveolar clefts and meeting the inclusion criteria will be enrolled and allocated into two groups. One group will receive double iliac corticocancellous bone block grafts, while the other will undergo reconstruction using conventional particulate bone grafting techniques.

Clinical and radiographic evaluations will be performed to assess graft stability, bone volume, and postoperative complications. Follow-up assessments will be conducted at predefined intervals to evaluate the success and predictability of each technique. The findings of this study are expected to provide evidence regarding the most effective grafting approach for bilateral alveolar cleft reconstruction

Вмешательства

• Процедура Iliac Corticocancellous Bone Block Graft
  participants will undergo bilateral alveolar cleft reconstruction using double iliac corticocancellous bone blocks harvested from the iliac crest. The grafts will be secured to premaxilla by micro screws to restore alveolar continuity, facilitate tooth eruption, and improve bone volume
• Процедура Autogenous Particulate Bone Graft
  participants will undergo bilateral alveolar cleft reconstruction using conventional autogenous particulate bone graft harvested from the iliac crest. The graft material will be packed into the alveolar defect to restore bone continuity and support future tooth eruption.

Первичные конечные точки

• bone volume [Срок оценки: 6 months]

Критерии участия

Критерии включения

• patients diagnosed with bilateral alveolar cleft requiring secondary alveolar bone graft.
• Medically fit for surgery under general anesthesia.
• Adequate soft tissue coverage at the cleft site.
• Patients (or guardians) able to provide informed consent.

Критерии исключения

• Unilateral alveolar cleft.
• Presence of systemic diseases affecting bone healing (e.g., Diabetes Mellitus uncontrolled, osteoporosis).
• Syndromic cleft patients.
• Poor oral hygiene or active infection at the surgical site.
• History of radiotherapy in the maxillofacial region.
• Contraindications to general anesthesia.
• Patients unwilling or unable to comply with follow-up.

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

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Faculty of Dentistry, Cairo University — Cairo

Идентификаторы

NCT: NCT07442279 · OMFS 3 3 8

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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