Ridge Preservation Comparing the Clinical and Histologic Healing of a Bioabsorbable Membrane Made of Polylactic Acid and a Citric Acid Ester vs. an Acellular Dermal Matrix Allograft GBR
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Change in crestal osseous 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 resorbable membranes to determine if either provides a significant therapeutic advantage.
详细描述
The control subjects will receive a bone graft in the extraction socket, plus an additional bone graft on the outside socket wall covered by a bioabsorbable membrane made of polylactic acid and a citric acid ester. The test subjects will receive same type and technique of bone graft with a the acellular dermal matrix membrane to cover the bone graft. The membrane the patients receive will be randomly assigned using a coin toss: heads will be assigned to the test group while tails will be assigned for controls. The objective is to determine if at 4 months the width and height of the jaw bone and also the soft tissue thickness where the tooth was extracted has increased, decreased or remained the same. Also the amount of patients own newly formed bone will be determined by microscopic examination of a core of jaw bone that will be obtained from the site of implant placement immediately before the implant is placed (the implant is not considered part of the study).
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
- 否
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 crestal osseous width
时间窗: 4 month
Horizontal post-extraction 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 post-treatment)
研究者
Henry Greenwell
Director, Graduate Periodontics
University of Louisville