A Randomized Controlled Clinical Trial to Investigate the Capability of Straumann® VivOss™ Compared to Geistlich Bio-Oss® in Sinus Floor Augmentation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 4
- 主要终点
- Ratio of Newly Formed Bone to Residual Bone Graft in Patients Treated With Straumann® VivOss™ Compared to Geistlich Bio-Oss®
研究概览
简要总结
A randomized controlled clinical trial to investigate the capability of Straumann® VivOss™ compared to Geistlich Bio-Oss in sinus floor augmentation to demonstrate superiority of Straumann® VivOss™ compared to Geistlich Bio-Oss in regards to the ratio of newly formed bone to residual bone substitute.
详细描述
This is a prospective, randomized, controlled study. The total study duration for each patient should be 9-14 months (from screening to last visit).
Enrolled subjects are randomized to one of the following groups:
- Sinus floor elevation with Straumann® VivOss™
- Sinus floor elevation with Geistlich Bio-Oss®
In total 6 visits per patient are scheduled in this study. The histological evaluation of the ratio of newly formed bone to residual bone graft, survival and success rate of study implants and adverse events (AEs) will be assessed.
The study devices Straumann® VivOss™ and Geistlich Bio-Oss are CE-(Conformité Européenne, meaning European Conformity) marked products.
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
- 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
- 是
入选标准
- •Subject must have voluntarily signed the informed consent before any study related action
- •Males and females with at least 18 years of age (including 18 years)
- •Subject needs augmentation procedure in the sinus to prepare for implant placement.
- •Subject must have a residual bone height of 2 to 4 mm.
- •Adequate oral hygiene ((Full mouth plaque index (O'Leary, et al. 1972 ) <25%) at baseline
- •Adequate control of inflammation ((full mouth bleeding on probing (Ainamo and Bay 1975)) ≤25% at baseline
排除标准
- •Systemic disease that would interfere with bone or wound healing and dental implant therapy (e.g. uncontrolled diabetes)
- •Systemic disease that would interfere with bone or wound healing and dental implant therapy (e.g. uncontrolled diabetes)
- •Any contraindications for general bone grafting and oral surgical procedures
- •Any anomalies of the sinus that could interfere with planned procedures
- •History of local irradiation therapy
- •Local inflammation, including untreated periodontitis
- •Medical conditions requiring chronic high dose steroid therapy
- •Treatment with an investigational drug or device within a 30 day period immediately prior to surgery at visit 2, or expected participation in any other investigational drug or device study during the conduct of this trial.
- •Antibiotic treatment or anti-inflammatory treatment within 4 weeks prior to surgery
- •History of alcoholism or drug abuse
- •Immunocompromised subjects
- •Subjects who smoke >10 cigarettes per day or tobacco equivalents or chew tobacco
- •Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance or unreliability
- •Physical or mental disabilities that would interfere with the ability to perform adequate oral hygiene
- •Current pregnancy (pregnancy test) and breastfeeding women
- •Secondary exclusion criterium:
- •Defects of the Schneider Membrane
研究组 & 干预措施
Straumann VivOss
Straumann® VivOss™Straumann® VivOss™, is a synthetic bone graft substitute in granulated form. It consists of > 90% TCP (Tri-Calcium-Phosphate -Ca3(PO4)2) and < 10% Hydroxyapatite (Ca10(PO4)6 (OH)2). The granules have a size of 250-1000 μm.
干预措施: Straumann VivOss (Device)
Geistlich Bio-Oss
The control device is Geistlich Bio-Oss® spongiosa granules (Geistlich Pharma AG, Wolhusen, Switzerland), 0.25-1 mm in diameter. It's a natural bone mineral of bovine origin. It shall be used according to the instructions of the manufacturer.
干预措施: Geistlich Bio-Oss (Device)
结局指标
主要结局
Ratio of Newly Formed Bone to Residual Bone Graft in Patients Treated With Straumann® VivOss™ Compared to Geistlich Bio-Oss®
时间窗: 6 months +/- 7 days after bone augmentation
Bone biopsies and histological staining
次要结局
- Survival Rate of Study Implants (Based on Subjects)(4 months +/- 1 month after implant placement)
- Success Rate of Study Implants(4 months +/- 1 month after implant placement)