Assessment of Facial Symmetry Following Fibula Free Flap Fixated in a Prosthetically Favorable Position Versus the Inferior Border Position for Mandibular Reconstruction: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Facial Symmetry
研究概览
简要总结
The study aims to evaluate facial symmetry outcomes after mandibular reconstruction using fibula free flaps, comparing two fixation techniques: the prosthetically favorable position (alveolar level) and the conventional position (inferior border level).
详细描述
The study aims to evaluate facial symmetry outcomes after mandibular reconstruction using fibula free flaps, comparing two fixation techniques: the prosthetically favorable position (alveolar level) and the conventional position (inferior border level).
Design:
A randomized controlled trial with parallel groups and a 1:1 allocation ratio. The study will assess facial symmetry and patient satisfaction over 12 months post-surgery.
Population:
Patients requiring mandibular reconstruction due to conditions like tumors, trauma, or osteomyelitis, with mandibular defects greater than 9 cm.
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
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who requires mandibular resection due to tumor, trauma, osteomyelitis or osteoradionecrosis.
- •Patient with Mandibular defect >9 cm.
排除标准
- •Patients with systemic condition counteracting with the surgical procedure.
研究组 & 干预措施
Mandibular reconstruction with fibula free flap fixated in inferior border level.
Fixation of the fibula in the inferior border level (conventional position).
干预措施: Fibula free flap (Procedure)
Mandibular reconstruction with fibula free flap fixated in the alveolar level.
Fixation of the fibula in the alveolar level (prosthetically favorable position) leaving 15-17mm till the opposing teeth.
干预措施: Fibula free flap (Procedure)
结局指标
主要结局
Facial Symmetry
时间窗: 6-12 months
Tool: 3D Stereophotogrammetry face scan. Unit: RMSD: root mean square deviation (Millimeters). Method: superimposition of the face scan color maps on Materialise's Interactive Medical Image Control System (MIMICS) Software.
次要结局
- Patient Satisfaction.(6-12 months)
研究者
Mohamed Ibrahim Ahmed Sakr
Ph.D. Candidate in Oral & Maxillofacial surgery departement.
Cairo University