NCT01905280已完成不适用
Ridge Preservation Comparing the Clinical and Histologic Healing of a PTFE Non-resorbable Membrane Versus an Acellular Dermal Matrix Allograft Plus a Facial Overaly Bovine Xenograft.
适应症
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
- Crestal ridge width
研究概览
简要总结
The purpose of this study is to compare the clinical and histologic outcomes for acellular dermal matrix and a nonresorbable membrane to determine if either provides a significant therapeutic advantage. The hypothesis is that there will be no difference in crestal ridge width between the two treatments.
详细描述
30 patients will be selected that meet the following criteria:
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
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 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
Crestal ridge width
时间窗: 4 months
The width of the ridge at the crest will be measured with a digital caliper.
次要结局
- Percent vital bone(4 months)
研究者
Henry Greenwell
Professor
University of Louisville
研究点 (2)
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