Prospective, Multi-Center Study of CopiOs® Pericardium Membrane With Puros® Cancellous Particulate Allograft for Localized Alveolar Ridge Augmentation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 8
- 主要终点
- Change in Horizontal Ridge Widths From Baseline to 6 Months
研究概览
简要总结
This is a prospective, multi-center study to evaluate the use of CopiOs Pericardium Membrane, a bovine xenograft, with use of Puros Cancellous Particulate Allograft, for the augmentation of localized alveolar ridge defects on either the maxilla or mandible.
详细描述
The study will evaluate the use of CopiOs Pericardium Membrane (CopiOs Pericardium), a bovine xenograft, with the use of Puros Cancellous Particulate Allograft (Puros Cancellous), a mineralized allograft, for the augmentation of localized alveolar ridge defects in edentulous sites. The purpose of the study will be to determine placement time, ease of use, stability, esthetics and to clinically evaluate the efficacy of the list products. A biopsy will be taken from a subset of the patient population, at one investigational site, to evaluate the grafted site's formation of new bone. The study hypothesis is that if CopiOs Pericardium and Puros Cancellous are used, the a single, localized alveolar ridge defect will clinically improve at an edentulous site.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Health status of P1(ASA I) or P2 (ASA II), as classified by the American Academy of Anesthesiologists
- •Able to communicate with the investigator and read, understand, and sign the informed consent form
- •No evidence of active moderate or severe periodontitis
- •Must be available for multiple follow-up visits for the duration of the study
- •The study site must exhibit a partially edentulous ridge of the maxilla or mandible with at least one tooth-span in length and less than 5.5 mm in its smallest buccolingual dimension as measured by ridge-mapping calipers (#RIDGE-CALIPER, Salvin Dental Specialties, Inc., Charlotte, NC).
排除标准
- •Inability or failure to maintain adequate oral hygiene
- •Women who are bread-feeding, pregnant, or who intend to become pregnant during this study period. Women of childbearing potential should be practicing a medically accepted method of birth control
- •Patients with unstable systemic diseases
- •Patients with compromised immune system (e.g. uncontrolled diabetes, etc.) or unstable bleeding disorder
- •Patients with active infectious diseases (e.g. hepatitis, tuberculosis, HEV, 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 or undergoing other immunosuppressive therapy
- •Radiation, cancer therapy, and/or radiation specifically at the oral cavity within the last 6 months
- •History of previous ridge augmentation at the site of interest
- •Augmentation sites with localized pathology
- •Patient who has participated in a clinical trial within 30 days of being enrolled in this study, is currently enrolled in another study, or plans to enroll in another study before the completion of of this study.
- •Unresolved oral pathologies (e.g. periodontal disease, caries, etc.)
- •Medications or conditions contraindicated for bone regeneration: methotrexate, corticosteroids, history of bisphosphonate use, cyclosporine-A, etc.
- •Patients who have more than a minimal tobacco use (e.g. >10 cigarettes per day)
- •Other conditions the investigator may feel would inhibit the patient from being a good candidate for this study or which are contraindicated in the Directions for Use.
- •Note: Careful consideration should be given to alternative therapies prior to performing bone grafting in patients who have severe endocrine-induced bone diseases (e.g.hyperparathyroidism), or who are undergoing current therapy with drugs that intervene in calcium metabolism.
结局指标
主要结局
Change in Horizontal Ridge Widths From Baseline to 6 Months
时间窗: 6 months
The primary outcome measure of the study was the average change in ridge width from baseline (pre operative/pre grafting) to 6 months post surgery. The ridge measurements were taken using ridge mapping calipers and recorded for each patient at baseline and 6 months. Baseline measurements were taken at the site of greatest ridge width deficiency as determined by the investigator and repeated at the same location for subsequent measurements. A radiographic template with a radiopaque foil was utilized to standardize clinical and radiographic measurements for each patient.
次要结局
- Mean Wound Healing Index at 6 Months(6 months)