NCT00520377Unknown2 期
Pilot Study on Safety and Efficacy of MD05 in Comparison With Beta-TCP in Patients Undergoing Sinus Floor Augmentation
Scil Technology GmbH9 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2005年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 31
- 试验地点
- 9
- 主要终点
- Area of newly formed mineralised bone tissue (%) as assessed by histomorphometry.
研究概览
简要总结
The primary objective is the area of newly formed bone (%) as assessed by histomorphometry with either MD05 or beta-TCP.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients requiring two-stage unilateral maxillary sinus floor augmentation (sinus lift) in case of insufficient bone height in the area of the posterior maxilla, prior to insertion of dental implants
- •Residual bone height at the site of planned implantation > 1 mm and < 5 mm
- •Male and female outpatients, 18 to 75 years old
- •Female patients must be infertile (either sterilized or postmenopausal). If a patient's menopausal status at screening is uncertain, levels of follicle stimulating hormone (FSH) should be determined. Patients with an FSH level > 25 IU/l and absence of menstrual bleeding > 6 months will satisfy the definition of postmenopausal status.
- •Patient has given informed consent.
排除标准
- •Women of childbearing potential, lactating women
- •Participation in another clinical study within 30 days prior to study start
- •Previous participation in this study
- •Last dental extraction (maxilla, posterior to canine) within the last 3 months
- •Failed sinus lift surgery and previous eradictive maxillary sinus surgery
- •Simultaneously bilateral sinus lift
- •Legal incompetence or restricted legal competence
- •Alcoholism, drug dependency, smoking
- •Acute or chronic infection at the application site, e.g., sinusitis
- •Known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV)
- •Severe allergic rhinitis which requires permanent medication (Rosenlicht 1999)
- •Known intolerance of or hypersensitivity to beta-TCP or rhGDF-5
- •Presence of local or systemic malignant disease or history of local or systemic malignant disease in the past 5 years
- •Patients requiring chemo- or radiotherapy
- •Previous or current radiotherapy of the head
- •Chronic liver disorder
- •Impaired renal function
- •Uncontrolled, insulin-dependent diabetes mellitus
- •Clinically relevant symptoms of thyroid dysfunction
- •Severe hypertension (RRdiast > 110 mmHg);
- •Clinically relevant cardiovascular disease
- •Systemic bone disease or illness having influence on bone metabolism,
- •Clinically relevant blood coagulation disorder,
- •Leukopenia < 3.500 leukocytes/µL
- •Previous or current treatment with systemic corticosteroids
- •Previous or current therapy with drugs having any influence on bone metabolism
- •Previous or current treatment with immunosuppressant medication
研究组 & 干预措施
1
Experimental
MD05
干预措施: MD05 (Drug)
2
Active Comparator
Beta-TCP and autologous bone
干预措施: Beta-TCP and autologous bone (Device)
结局指标
主要结局
Area of newly formed mineralised bone tissue (%) as assessed by histomorphometry.
时间窗: Within 4 months after surgery
次要结局
- evidence of uncompromised healing(January 2008)
研究者
研究点 (9)
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