Three-Dimensional Bone Augmentation of Severely Atrophied Posterior Mandibular Alveolar Ridges Using Customized-3D Zirconia Barriers Versus Pre-bent Titanium Mesh

Официальное название

Assessment of Three-Dimensional Bone Augmentation of Severely Atrophied Posterior Mandibular Alveolar Ridges Using Customized-3D Zirconia Barriers Versus Pre-bent Titanium Mesh: A Randomized Controlled Clinical Trial

Обзор

Zirconia can be considered as an alternative and innovative material suitable for GBR because it has high biocompatibility, together with a scarce tissue integration. Zirconia barriers could be a predictable and alternative barrier material for GBR in terms of (i) biocompatibility, (ii) ease of use and removal, (iii) exposure management, (iv) bone regeneration outcomes.

Вмешательства

• Другое customized Zirconia barrier
  It includes eight patients seeking for placement of customized Zirconia barrier after GBR in 1st stage surgery then implants placement in 2nd stage surgery in the alveolar ridges.
• Другое prebent titanium mesh
  It includes eight patients seeking for placement prebent titanium mesh as barriers after GBR in 1st stage surgery then implants placement in 2nd stage surgery in the alveolar ridges.

Первичные конечные точки

• change in vertical height of ridge [Срок оценки: up to 6 months]
• change in horizontal width of ridge [Срок оценки: up to 6 months]
• change in volume of ridge [Срок оценки: up to 6 months]

Вторичные конечные точки (2)

• symptoms of infection [Срок оценки: up to one month]
• manifestations of wound healing disturbance [Срок оценки: up to one month]

Критерии участия

Критерии включения

• Patients are systemically medically free according to the American Society of Anesthesiologists (ASA) considered as ASA I.
• Ability to maintain good oral hygiene as evidenced in recall visits.
• patients who had a partial or completely edentulous alveolar ridge with apparent 3D defect following teeth loss.
• All patients were free from any local or general disease that may interfere with bone healing and had no history of previous grafting procedure at the designated edentulous ridge.
• The ridge had to exhibit severe vertical and horizontal (3D) alveolar ridge deficiency with alveolar ridge height less than 7 mm from the alveolar crest to the inferior alveolar canal and width less than 5 mm which was firstly measured by CBCT, or a clinically apparent increase in inter-arch space relative to the adjacent natural teeth.
• Pre-operative clinical assessment of soft tissue coverage was done to cover the graft and its membrane, in addition to assessment of occlusion and inter-arch distance should allow for the graft, membrane, implan and the future prosthesis.

Критерии исключения

• Smoker (> 25 cigarettes/ day).
• Patients undergoing radiotherapy or chemotherapy
• Patients having infection or local lesions in the area of surgery.
• Patients with diabetes mellitus or bone diseases which may compromise the results.
• Patient with poor oral hygiene or active periodontal disease.
• Patient with limited mouth opening.
• Participation in other clinical trials

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

Египет · 1 центр

• Kafr El-sheikh University — Kafr Elsheikh

Идентификаторы

NCT: NCT07700095 · KFSIRB200-205

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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