NCT04006782进行中（未招募）不适用
Narrow Dental Implants in Multiple Fixed Prosthesis
Fundación Eduardo Anitua1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2019年8月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Survival after 5 years of follow-up
研究概览
简要总结
The objective of this study is to evaluate the survival of narrow dental implants (≤ 3,5 mm) in multiple fixed prostheses in comparison with standard diameter dental implants (≥ 3,75 mm) after 5 years of follow-up. The hypothesis of the study is that narrow dental implants under the evaluated conditions, have the same survival rate and clinical performance than the standard diameter implants.
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
- 是
入选标准
- •Patients of legal age (>18 years) of both sexes.
- •Clinical need of multiple fixed alveolar ridge rehabilitations.
- •Clinical suitability to insert, at least, one narrow dental implant splinted to a standard diameter dental implant.
- •Signature of the informed consent
排除标准
- •Presence of an active infection
- •Being under active treatment with, or have received in the las 30 days treatment with radiotherapy, chemotherapy, immunosuppressors, systemic corticosteroids and/or anticoagulants.
- •Presence of severe haematologic disorders.
- •Chronic treatment with non steroidal anti-inflammatory drugs (NSAID) or other aniinflammatory drugs.
- •Previous diagnosis of chronic hepatitis or liver cirrhosis.
- •Presence of Diabetes mellitus with improper metabolic control (glycosylated haemoglobine higher that 9%).
- •Patients subjected to dialysis.
- •Presence of malignant tumours, haemangioma or angioma in the surgical area.
- •History of ischaemic cardiopathy in the las year.
- •Pregnancy or plan to getting pregnant during the study.
- •Metabolic bone disease
- •Patientd receiving treatment with oral or intravenous biphosphonates.
- •Any other condition incompatible with the participation in the study,
研究组 & 干预措施
Narrow dental implants in multiple fixed prosthesis
Other
干预措施: Narrow dental implants (Device)
结局指标
主要结局
Survival after 5 years of follow-up
时间窗: 5 years in comparison with the baseline
Implant survival after 5 years of follow-up
次要结局
- Marginal Bone Loss(1, 3 and 5 years in comparison with the baseline)
研究者
研究点 (1)
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