NCT05584566招募中不适用
Ridge Augmentation Treatment Using OSSIX® BREEZE vs Jason® Membrane in Simultaneous Implantations. A Prospective, Randomized Controlled Trial.
Datum Dental LTD4 个研究点 分布在 2 个国家目标入组 65 人开始时间: 2022年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 65
- 试验地点
- 4
- 主要终点
- increase in bone gain
研究概览
简要总结
This is a prospective randomized controlled parallel trial. The aim of this study is to evaluate bone formation and soft tissue healing after 4 and 8 months in patients with ridge deficiencies in simultaneous implantation approach. The trial will compare a (sugar cross linked) - SCL pericardium membrane OSSIX® Breeze vs native pericardium membrane (Jason®).
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 (Participant)
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
- •Males and females, age 18 and above.
- •General good health (ASA 1 and ASA 2).
- •Adults with buccal bone defect, who are in need of implant placement, and going through a guided bone regeneration treatment.
- •Patient needs 1-3 implants.
- •Good oral hygiene (full mouth plaque index <25%).
- •Adequate control of inflammation (full mouth bleeding on probing <25%).
- •Patient is willing to sign an informed consent and participate in the clinical study.
- •Patient is able to understand and comply with the study related procedures, such as exercising good oral hygiene and attending all follow-up examinations.
排除标准
- •Physical status ASA III or ASA IV.
- •General contraindications for dental and/or surgical treatments.
- •Inflammatory and autoimmune disease of the oral cavity.
- •Patients with known collagen hypersensitivity.
- •Patients with sensitivity to porcine-derived materials.
- •Patients suffering from autoimmune diseases and connective tissue diseases, such as: systemic lupus erythematosus, dermatomyositis, etc.
- •Acute infection in the oral cavity or acute inflammation at the implantation site.
- •General diseases, where measures of stomatology, maxillo-facial surgery, implantology, periodontology, endodontology or other measures of oral surgery are contraindicated.
- •Disease of oral mucosa.
- •Uncontrolled periodontal disease
- •Concurrent or previous radiotherapy of head area.
- •Concurrent or previous immunosuppressant, bisphosphonate, or high-dose corticosteroid therapy.
- •Smoking (over 10 cigarettes a day).
- •Pregnant or lactating women.
- •Women of childbearing potential, who are not using a highly effective method of birth control.
- •Participation in another investigational device, drug, or biologics study within the last 24 weeks prior to study entry.
结局指标
主要结局
increase in bone gain
时间窗: 4 months
increase in bone gain (vertical and horizontal) in mm, 4 months after the implant placement in the augmented site. the measurment will be done according to radiographic images
次要结局
未报告次要终点
研究者
研究点 (4)
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