Freeze-dried Bone Allograft vs Autologous Bone Blocks in the Lateral Augmentation of the Jaws

Официальное название

Comparison of Freeze-dried Bone Allograft and Autogenous Bone Blocks in the Surgical Reconstruction of Horizontally Atrophied Jaws for Implant Placement: Randomized Clinical Trial

Обзор

After tooth loss, the alveolar ridge undergoes various modeling and remodeling processes, resulting in overall bone resorption. In case of extensive alveolar atrophy, bone volume must be restored before or during implant placement to achieve successful dental rehabilitation and maximize implant survival and success rates. One possible method for reconstructing severe bone resorption is block bone augmentation. Due to its biological properties, autologous bone is considered the "gold standard" among bone graft materials, as it possesses osteoinductive, osteoconductive, and osteogenic properties. The advantages of using allografts over autologous bone grafts include reduced postoperative morbidity, decreased surgical time, and the absence of anatomical limitations regarding the amount of bone that can be harvested. The disadvantage of allografts is the loss of viable osteogenic cells and osteoinductive factors during processing. The aim of the study is: * to compare the success of the bone augmentation surgery depending on whether freeze-dried bone allograft blocks or autologous bone blocks are used, * compare the microarchitecture of the augmented bone depending on the bone graft material applied, * to evaluate the success of dental implants placed in the augmented bone and that of the prostheses delivered on the dental implants.

Вмешательства

• Процедура Bone augmentation using an autologous bone block
  * Under local anesthesia, a crestal and mesial releasing incision is made, followed by preparation of a full-thickness mucoperiosteal flap. * In the control group, an autologous bone block graft is harvested from the retromolar donor area using rotary instruments and piezoelectric surgery. * The block is fixed to the recipient site with two screws. * The flap is mobilized, and the wound is closed tension-free with mattress and simple interrupted sutures. * Sutures are removed two weeks postopera
• Процедура Bone augmentation using freeze-dried allograft block
  * Under local anesthesia, a crestal and mesial releasing incision is made, followed by preparation of a full-thickness mucoperiosteal flap. * In the test group, a freeze-dried allograft bone block is prepared to the required size using rotary instruments. * The block is fixed to the recipient site with two screws. * The flap is mobilized, and the wound is closed tension-free with mattress and simple interrupted sutures. * Sutures are removed two weeks postoperatively. * All patients receive ther
• Диагностический тест preoperative cone beam computed tomography (CBCT)
  • Preoperatively, a CBCT scan is performed to assess inflammatory and other pathological changes and anatomical variations in the dentomaxillofacial region.
• Диагностический тест post-operative cone beam computed tomography (CBCT)
  Postoperatively, a CBCT scan is performed to assess bone quantity and quality before implantation.
• Процедура Dental implant placement
  Following the 3-month-long healing period following bone augmentation, dental implants are placed non-submerged in the augmented bone under local anaesthesia.
• Диагностический тест Bone core biopsy
  At the time of dental implant placement, a rotary instrument is used to harvest a bone core biopsy sample from the augmented bone. The bone core biopsy samples are subjected to histomorphometric and microCT analysis.
• Процедура Fixed dental prosthesis (FDP) fabrication
  After 3 months of dental implant placement, fixed dental prosthesis are delivered on the dental implants.
• Устройство Bone grafting
  Freeze-dried bone allograft block

Первичные конечные точки

• Success of the bone augmentation [Срок оценки: 3 months]
• Success of the dental implants [Срок оценки: 3 months]
• Success of the implant-borne prostheses [Срок оценки: 5 years]

Вторичные конечные точки (11)

• Hisomorphometry: Percent of residual bone graft particles [Срок оценки: 3-6 months]
• Hisomorphometry: Percent of newly formed bone [Срок оценки: 3-6 months]
• Hisomorphometry: Percent of bone marrow [Срок оценки: 3-6 months]
• Value of the percent bone volume (BV/TV) calculated from the microCT reconstructions of the bone core biopsy samples [Срок оценки: 3-6 months]
• Value of the bone surface to volume ratio (BS/TV), calculated from the microCT reconstructions of the bone core biopsy samples [Срок оценки: 3-6 months]
• Value of the trabecular thickness (Tb.Th.) calculated from the microCT reconstructions of the bone core biopsy samples. [Срок оценки: 3-6 months]
• Value of the trabecular separation (Tb.Sp.), calculated from the microCT reconstructions of the bone core biopsy samples. [Срок оценки: 3-6 months]
• Value of the trabecular bone pattern factor (Tb.Pf), derived from microCT reconstructions of bone core biopsy samples. [Срок оценки: 3-6 months]
• Value of the structure model index (SMI), calculated from the microCT reconstructions of the bone core biopsy samples. [Срок оценки: 3-6 months]
• Value of the Total porosity (Po(tot)), calculated from the microCT reconstructions of the bone core biopsy samples. [Срок оценки: 3-6 months]
• Value of the Connectivity (Conn), calculated from the microCT reconstructions of the bone core biopsy samples. [Срок оценки: 3-6 months]

Критерии участия

Критерии включения

• over 18 years old
• require lateral augmentation for implant rehabilitation

Критерии исключения

• Smoking
• Pregnancy
• Poor oral hygiene
• Failure to attend follow-up visits
• Therapeutic-dose irradiation to the head and neck region
• Local bone tumors, cysts, or inflammatory processes
• Decompensated systemic diseases contraindicate surgery
• Use of medications affecting bone metabolism (steroids, antiresorptive medications such as bisphosphonates, RANKL inhibitor antibodies, VEGF antagonists)
• Psychiatric disorders contraindicate implant rehabilitation

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

Венгрия · 1 центр

• Semmelweis University Department of Public Dental Health — Budapest

Идентификаторы

NCT: NCT07104370 · SEDCD45

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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