Alveolar Ridge Preservation Using a Flap Versus Flapless Technique Using a Demineralized Bone Matrix Allograft Plus Mineralized Particulate Allograft and a Calcium Sulfate Barrier
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Crestal Horizontal Ridge Width
研究概览
简要总结
To compare a flapless technique of alveolar ridge preservation to a flap technique to determine if preserving the periosteal blood supply would prevent loss of crestal ridge width and height.
详细描述
Twenty-four patients will randomly be assigned to receive ridge preservation using either flapless or flap technique. Twelve test patients will receive ridge preservation using a flapless approach and twelve control patients will receive ridge preservation using a flap technique. All sockets will be grafted with demineralized bone matrix and mineralized particulate allograft and covered with calcium sulfate barrier. Re-entry surgery will be performed at 4 months when a trephine core will be taken from the grafted site immediately prior to implant placement and submitted for histologic processing.
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
- •Have one non-molar tooth requiring extraction that will be replaced with a dental implant where at least one adjacent tooth is present
- •Study subjects at least 18 years old
- •Patients must sign an informed consent approved by the University of Louisville Human Studies Committee of Institutional Review Board.
排除标准
- •Patients with debilitating systemic disease, or a disease affects the periodontium
- •Have an allergy to any material or medication used in the study
- •Require prophylactic antibiotics
- •Previous head and neck radiation therapy
- •Chemotherapy in the previous 12 months
- •Patients taking long term Non-steroidal Anti-inflammatory Drugs or steroid therapy
- •Smoked more than one pack of cigarettes per day
结局指标
主要结局
Crestal Horizontal Ridge Width
时间窗: 4 months after surgery
Changes in post-extraction to 4 month change in ridge measurements at the alveolar crest and 5 mm apical to crest. Measurements taken with a caliper.
次要结局
- Percent osseous tissue(4 months after surgery)
