Bone Quality Assessment Following Application of Adipose Tissue Derived Autologous Mesenchymal Stem Cell Concentrate in the Management of Mandibular Fractures. A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Bone density
研究概览
简要总结
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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.
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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.
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Participants will:
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Be managed either by adipose tissue derived-MSCs concentrate application with ORIF or ORIF alone.
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Undergo CBCT immediately (T1) and 3 months (T4) postoperatively for bone density radiographic evaluation
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Visit the clinic postoperatively at one week (T2), one month (T3), three months (T4) for clinical examination
详细描述
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with mandibular fracture.
- •Patients who are willing to participate in the study
排除标准
- •Patients with systemic diseases influence bone healing
- •Patients with pathological fractures.
- •Infection located at the zone to be treated
研究组 & 干预措施
Study group
10 patients with mandibular fracture will be treated by application of adipose tissue derived MSCs concentrate on fracture line before and following fixation with titanium plates and screws.
干预措施: Adipose tissue derived mesenchymal stem cells concentrate application in addition to the open reduction and internal fixation. (Procedure)
Control group
10 patients with mandibular fracture will be treated by open reduction and internal fixation with titanium plates and screws.
干预措施: Open reduction and internal fixation (Procedure)
结局指标
主要结局
Bone density
时间窗: 3 months
Assessment of bone density at fracture healing site by CBCT
次要结局
- Soft tissue dehiscence(3 month)
- Bleeding(3 months)
- Infection(3 months)
- Malocclusion(3 months)
研究者
Mona Mahmoud Abdulhameed
Principal Investigator
Cairo University