Implant Placement and Simultaneous Soft Tissue Grafting With Single or Double Layers of Acellular Dermal Matrix: A Randomized, Controlled Clinical Tria.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Soft tissue thickness.
研究概览
简要总结
The purpose of this study is to compare the effect on soft tissue thickness of placing either a single or double layer of acellular dermal matrix simultaneous with dental implant placement. The hypothesis is that 2 layers of acellular dermal matrix will produce thicker tissues that one layer.
详细描述
Patients must be greater that 18 years old, not pregnant, and have an edentulous space with a tooth on each side that is treatment planned to receive a dental implant. The primary outcome measure is soft tissue thickness.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The inclusion criteria were;
- •one edentulous site bordered by 2 teeth in the maxilla or mandible from first molar to first molar treatment planned to receive an implant
- •at least 18 years of age
- •must sign the informed consent -
排除标准
- •The exclusion criteria included:
- •uncontrolled diabetes, immune disease, or any systemic disease that significantly affects the periodontium
- •previous head and neck radiation
- •oral bisphosphonates for > 3 years or any IV bisphosphonates
- •smoking > 1/2 pack per day or other tobacco habits that might interfere with soft tissue healing
- •requirement for prophylactic antibiotics
- •allergies to any medication or material used in the study, or that would adversely affect study procedures
- •chemotherapy in the previous 12 months
- •psychological problems that would interfere with treatment
- •patients unable or unwilling to sign the informed consent
- •pregnancy -
研究组 & 干预措施
one layer allograft
One layer allograft as a positive control
干预措施: One layer allograft (Procedure)
Two layer allograft
Two layer allograft as the test group.
干预措施: Two layer allograft (Procedure)
结局指标
主要结局
Soft tissue thickness.
时间窗: 4 months
Determining the soft tissue thickness using a tissue probe.
次要结局
未报告次要终点
研究者
Henry Greenwell
Professor
University of Louisville