NCT01654627Unknown1 期
Horizontal Guided Bone Regeneration for Dental Implants Using Synthetic Membrane (Regenecures' AMCA GBR Dental Membrane) a Prospective, Randomized,Controlled Study.
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Bone volume
研究概览
简要总结
The purpose of this study is to examine the safety and usefulness of the Regenecure guided bone regeneration membrane for stimulating bone growth in patients that don't have enough bone for dental implant placement. The study will include 16 patients in each group, 20 non-smokers and 12 smokers, a total of 32 patients will participate in the study.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must have voluntarily signed the informed consent form before any study related action
- •Age: 18 to 65 with missing teeth, seeking for implant therapy.
- •Men/Women
- •In good systemic health
- •Present with no contra indication against oral surgical interventions
- •Single/ multiple tooth gap - have at least one missing tooth in the mandible or maxilla, requiring one or more dental implants.
- •The tooth at the implant site(s) must have been extracted or lost at least 6 weeks before the date of implantation.
- •Bone defect(s) must be present with a lateral dimension greater than or equal to 5 mm or less.
- •Full mouth plaque score (FMPI) lower or equal than 25%
- •Patients must be committed to the study
排除标准
- •Medical conditions requiring prolonged use of steroids
- •Use of Bisphosphonate intravenously
- •Current pregnancy or breastfeeding women
- •Alcoholism or chronically drug abuse
- •Immunocompromised patients
- •Uncontrolled Diabetes
- •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.
- •Untreated inflammation
- •Mucosal diseases or oral lesions
- •History of local irradiation therapy
- •Persistent intraoral infection
- •Patients with bad oral hygiene or unmotivated for normal home care.
结局指标
主要结局
Bone volume
时间窗: Change from Baseline in bone volume at 6 months
Clinical effect on bone volume measured using CBCT. The volume of the newly formed bone will be evaluated by "subtraction" of the 2 cone beam CTs using digital measurements.
次要结局
- Histomorphometry(6 months)
- Safety will be demonstrated by using VAS scale for pain measurements and if the PI will consider that any adverse event device related isn't clinically significant(six months)
研究者
研究点 (1)
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