Multi-center, Post-market, Prospective, Randomized, Examiner-Only-Masked Study of Root Coverage With Acellular Dermal Matrix: Puros® Dermis Versus Alloderm®
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 8
- 主要终点
- Non -Inferiority of Dermis to Alloderm
研究概览
简要总结
The purpose of the study is to evaluate whether clinical parameters for Puros Dermis are, at minimum, equivalent when compared to AlloDerm, the current industry standard, for the treatment of single, non-adjacent Miller's Class I or II gingival recession.
详细描述
This is a prospective, Post-market, Randomized, Examiner-Only Masked multi-center study to evaluate whether clinical parameters for Puros Dermis are at minimum, equivalent when compared to Alloderm, the current industry standard for the treatment of single, non-adjacent Miller's Class I or II gingival recession.
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
- •Male or female, of any ethnicity, between 18 and 99 years of age.
- •No known allergies to study material.
- •Able to communicate with the investigator and read, understand, and sign the informed consent form.
- •Maxillary incisor, canine, or premolar with at least one Miller's Class I or II gingival recession defects that are not adjacent to one another.
- •Depth of the gingival recession defects of 2mm or greater.
- •No gingival surgery within the past 12 months at the defect site. No prior antibiotic use within 3 months with less than 2 weeks durations.
- •Ability to maintain good oral hygiene.
排除标准
- •Patients taking any medications known to cause gingival enlargement.
- •Patients with unstable systemic diseases.
- •Patients with compromised immune systems or unstable bleeding disorders.
- •Patients with active infectious diseases (e.g. hepatitis, tuberculosis, HIV, etc.).
- •Patients with a mental disability that may hinder participation in the study (e.g. inability to follow through with oral hygiene instructions, postoperative instructions, follow-up commitments, etc.).
- •Patients taking steroid medications.
- •Tobacco use or smoking within 1 year of screening visit (e.g. cigarettes, pipes, cigars, chew).
- •Pregnant females or females attempting to get pregnant.
- •Other conditions the investigator feels would inhibit from a good candidate for the study.
结局指标
主要结局
Non -Inferiority of Dermis to Alloderm
时间窗: 12 months
Non -inferiority of Dermis to Alloderm will be assessed by comparison of the average change (from the preoperative value) in gingival recession measured at 12 months between defects receiving Puros Dermis and those receiving Alloderm.
次要结局
未报告次要终点