Effect of Adipose Tissue Derived Autologous Mesenchymal Stem Cell Concentrate on Bone Quality in Mandibular Fracture Healing.

Официальное название

Bone Quality Assessment Following Application of Adipose Tissue Derived Autologous Mesenchymal Stem Cell Concentrate in the Management of Mandibular Fractures. A Randomized Clinical Trial

Обзор

* The goal of study is to evaluate the effectiveness of adipose tissue derived-MSCs concentrate application in mandibular fractures. The main question it aims to answer is: Does intervention enhance bone quality, reduce complications and reduce bone regeneration time. * Researchers will compare the effectiveness of adipose tissue derived-MSCs concentrate application with ORIF to ORIF alone to see if MSCs improve healing in mandibular fractures. * Participants will: * Be managed either by adipose tissue derived-MSCs concentrate application with ORIF or ORIF alone. * Undergo CBCT immediately (T1) and 3 months (T4) postoperatively for bone density radiographic evaluation * Visit the clinic postoperatively at one week (T2), one month (T3), three months (T4) for clinical examination

Подробное описание

* From oral and maxillofacial surgery outpatient clinic, Faculty of Dentistry, Cairo University. 20 patients will be included in this study, the patients will be randomly distributed into two groups each containing 10 patients, one group will be treated by application of adipose tissue derived autologous mesenchymal stem cell concentrate before and after fixation and the other group will be treated by fixation only without application of adipose tissue derived autologous mesenchymal stem cell concentrate. * All surgeries (for study and control groups) will be carried out with endotracheal intubation under general anaesthesia. * After scrubbing the surgical field with a povidone-iodine surgical scrub solution, the patients will be draped in sterile towels such that only the surgical site will be visible. * The fracture line will be exposed, followed by mobilization of the fracture, and removal of any soft tissue entrapped within the fracture line. Intermaxillary fixation (IMF) will be done and temporarily secured to provide proper occlusion that will serve as a guide for fracture reduction. * The reduction of the bone into appropriate anatomical occlusion will then be visually verified by confirming that the mandible is properly aligned. After that, the titanium plate is positioned and secured with titanium screws. * For the study group, abdominal lipo- suction will be carried out for the subsequent receive and gain of fat-derived stem cells following the microfragmentation of adipose tissue. This lipo-aspirate containing MSCs will be applied on fracture line before and following fixation.

Вмешательства

• Процедура Adipose tissue derived mesenchymal stem cells concentrate application in addition to the open reduction and internal fixation.
  Abdominal fat liposuction will be carried out, microfragmentation of adipose tissue will be performed. Then the filtrate containing mesenchymal stem cells concentrate will be applied to the fracture line before and following fixation with titanium plates and screws .
• Процедура Open reduction and internal fixation
  Open reduction and internal fixation of fracture line with titanium plates and screws

Первичные конечные точки

• Bone density [Срок оценки: 3 months]

Вторичные конечные точки (4)

• Soft tissue dehiscence [Срок оценки: 3 month]
• Bleeding [Срок оценки: 3 months]
• Infection [Срок оценки: 3 months]
• Malocclusion [Срок оценки: 3 months]

Критерии участия

Критерии включения

• Patients with mandibular fracture.
• Patients who are willing to participate in the study

Критерии исключения

• Patients with systemic diseases influence bone healing
• Patients with pathological fractures.
• Infection located at the zone to be treated

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Castillo-Cardiel G, Lopez-Echaury AC, Saucedo-Ortiz JA, Fuentes-Orozco C, Michel-Espinoza LR, Irusteta-Jimenez L, Salazar-Parra M, Gonzalez-Ojeda A. Bone regeneration in mandibular fractures after the application of autologous mesenchymal stem cells, a randomized clinical trial. Dent Traumatol. 2017 Feb;33(1):38-44. doi: 10.1111/edt.12303. Epub 2016 Sep 13. PMID 27513920

Идентификаторы

NCT: NCT07671183 · 3319

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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