COMPARATIVE ANALYSIS OF INNOVATIVE BONE HEALING TECHNIQUES IN MANDIBLE BONE DEFECTS
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- bone density
研究概览
简要总结
the study intends to observe the outcome of interventions (concentrated growth factor with autograft and xenograft) used to expedite bone healing and adaptation with minimal side effects. Three different modalities are being used to bridge the mandibular fracture defects (>5mm-<5cm). Those modalities include group A- autograft, group B-autograft with concentrated growth factor, and group C- xenograft with concentrated growth factor. the outcomes are measured in terms of acquired bone density (Hounsfield unit) that is obtained at the 4th and 6th month post-operatively via cone-beam computed tomography.
详细描述
Study Design:
Randomized clinical trial
Study Population:
The study will be conducted on patients with mandible fracture defects, exclusively of defect sizes ranging from 5mm to 5cm.
Study Settings:
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
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male/female
- •Mandible fracture (symphysis, parasymphysis, and body)
- •Defect gap of bone >5mm and <5cm.
- •Non-union fracture. (Fracture that does not heal after 8 weeks of treatment is known as a non-union)
- •Mal-union (when the fracture segments are not in anatomical alignment and heals in that way forming a bone between displaced segments)
- •Delayed union (Fracture which takes greater than 5 weeks to repair is a delayed union)
排除标准
- •Systemic disease involvement such as diabetes mellitus.
- •Bone-related disorders such as osteoarthritis,
- •Undergoing Chemo and or radiotherapy
- •Gunshot trauma with more than 5cm bone defect
- •Fracture with open wounds
研究组 & 干预措施
Group A
group A- autograft
干预措施: autograft (Procedure)
group B
group B- concentrated growth factor with autograft
干预措施: autograft with addition of concenterated growth factor (Procedure)
Group C
group C- concentrated growth factor with xenograft
干预措施: xenograft with concentrated growth factor (Procedure)
结局指标
主要结局
bone density
时间窗: 6 months
acquired bone density in region of interest via cone beam computed tomography expressed in Hounsfield units
次要结局
未报告次要终点
研究者
Samreen Malik
Doctor (MDS trainee)
Dow University of Health Sciences