Ridge Preservation Comparing the Clinical and Histologic Healing of Membrane vs. no Membrane Approach to Grafting.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change in post-extraction site to 4 month change in crestal osseous width
研究概览
简要总结
Ridge Preservation Comparing the Clinical and Histologic Healing of Membrane vs. no Membrane Approach to Grafting.
详细描述
Thirty patients will be treated using the principles of bone grafting for ridge preservation. Fifteen test patients will receive a flap technique with an intrasocket cancellous cortical particulate allograft plus a facial overlay graft using a bovine xenograft without a membrane where only the exposed intrasocket allograft will be covered with a piece of Alloderm GBR. The positive control group of fifteen patients will receive a flap technique with an intrasocket cancellous cortical particulate allograft plus a facial overlay graft using a bovine xenograft plus Alloderm GBR membrane. Approximately, four months post-surgery, 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
- Double (Participant, 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 by a dental implant. The site must be bordered by at least one tooth.
- •Healthy male or female who is at least 18 years old.
- •Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.
排除标准
- •Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium.
- •Presence or history of osteonecrosis of jaws.
- •Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration.
- •Patients who have been treated with oral bisphosphonates for more than three years.
- •Patients with an allergy to any material or medication used in the study.
- •Patients who need prophylactic antibiotics
- •Previous head and neck radiation therapy.
- •Chemotherapy in the previous 12 months.
- •Patients on long term NSAID or steroid therapy.
- •Pregnant patients.
结局指标
主要结局
Change in post-extraction site to 4 month change in crestal osseous width
时间窗: 4 months
Changes in post-extraction to 4 month change in ridge measurements at the mid defect alveolar crest and 5 mm apical taken with a caliper.
次要结局
- Percent osseous tissue(4 months)
- Change in Soft tissue thickness(4 months)
研究者
Henry Greenwell
Professor
University of Louisville