Ridge Augmentation Comparing the Clinical and Histologic Healing of a Cancellous Block Allograft Plus a Barrier Membrane With and Without Primary Closure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Crestal ridge width
研究概览
简要总结
This study is designed to compare the clinical and histologic results of ridge augmentation with and without primary closure over the barrier membrane. The hypothesis is that there will be no difference in crestal ridge width between the two groups.
详细描述
A maximum of 30 patients will be selected that meet the following criteria:
Inclusion Criteria
- At least a one tooth area with a ridge defect, treatment planned to receive a dental implant. The site must be bordered by at least one tooth.
- Healthy person that is at least 18 years old.
- Patient understands and signs an informed consent approved by the University of Louisville Human Studies Committee.
Exclusion Criteria
- Patients with debilitating systemic diseases, diseases that affect the periodontium, or psychological problems that would interfere with treatment.
- Previous head and neck radiation or chemotherapy within the previous 12 months.
- Patients with known allergy to any of the materials that will be used in the study.
- Smokers.
- Patients who need prophylactic antibiotics prior to dental procedures.
- Patients on long-term steroid therapy or oral bisphosphonates > 3 years or any IV biosphosphonates.
- Patients who are pregnant.
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
- •At least a one tooth area with a ridge defect, treatment planned to receive a dental implant. The site must be bordered by at least one tooth.
- •Healthy person that is at least 18 years old.
- •Patient understands and signs an informed consent approved by the University of Louisville Human Studies Committee.
排除标准
- •Patients with debilitating systemic diseases, diseases that affect the periodontium, or psychological problems that would interfere with treatment.
- •Previous head and neck radiation or chemotherapy within the previous 12 months.
- •Patients with known allergy to any of the materials that will be used in the study.
- •Patients who need prophylactic antibiotics prior to dental procedures.
- •Patients on long-term steroid therapy or oral bisphosphonates > 3 years or any IV biosphosphonates.
- •Patients who are pregnant.
研究组 & 干预措施
With primary closure
The ridge augmentation graft will be covered with a barrier membrane and the soft tissue will be primarily closed.
干预措施: With primary closure (Procedure)
Without primary closure
The ridge augmentation graft will be covered with a barrier membrane and the soft tissue will not be primarily closed.
干预措施: Without primary closure (Procedure)
结局指标
主要结局
Crestal ridge width
时间窗: 4 months
The ridge width at the crest will be compared between the two treatment groups.
次要结局
- Percent vital bone(4 months)
研究者
Henry Greenwell
Professor
University of Louisville