A Prospective Study of Bone Augmentation Techniques in Extraction Sockets
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Changes in Hard Tissue Composition
研究概览
简要总结
The study will compare the density and strength of regenerated bone in extraction sockets after being grafted with two different materials: Bone Allograft and Bone Allograft with Amnion.
The investigators hypothesize that sockets grafted with the Amnion graft will exhibit enhanced healing patterns and will accelerate the formation of regenerated bone in the grafted areas.
详细描述
The amniotic allograft is a cryopreserved allograft tissue matrix derived from human placental tissues recovered from live healthy donors. Amniotic tissue is an abundant source of collagen which provides an extracellular matrix to act as a natural scaffold for cellular attachment in the body; collagen provides a structural tissue matrix that facilitates cellular migration and proliferation in-vivo. The product is developed using proprietory techniques by BioDlogics, LLC. The amniotic allograft growth factors are thought to enhance formation of a supportive scaffold for regeneration, to facilitate interactions between cell types, and to influence anti-inflammatory, anti-microbial and immuno-privilege activities.
Atraumatic extractions and socket grafts will be performed. Dental implants will be inserted into the grafted areas 8 weeks post-graft. The implants will be restored and followed for 24 months post-insertion.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be a registered University of Alabama at Birmingham (UAB) dental school patient
- •Existence of one or more non-adjacent teeth in the aesthetic zone that are scheduled for extraction
- •Healthy enough to undergo the proposed therapy
- •Demonstrated willingness to comply with study directions and time-line
- •Able to consent for themselves
- •Able to read and understand the informed consent form -
排除标准
- •Pregnant or lactating at the time of enrollment
- •Previous Malignant neoplasm
- •Known hypersensitivity to bone grafting materials
- •Know hypersensitivity to titanium
- •Any medical of medication that in the opinion of the investigators may adversely affect bone healing
- •Any indication of an inability to make autonomous decisions -
结局指标
主要结局
Changes in Hard Tissue Composition
时间窗: baseline to week-8
A biopsy will be harvested from each grafted-site and sent to a laboratory for histological and histomorphometric analysis
次要结局
- Changes in Soft Tissue Healing(2 weeks to 7 weeks)
研究者
Maninder Kaur
Principal Investigator
University of Alabama at Birmingham