DRKS00018852招募中不适用
Prospective clinical study to evaluate the clinical performance of immediately loaded PURE ceramic implants.A monocentric study - PURE 121
Poliklinik für Zahnärztliche Chirurgie und Implantologie, ZZMK, Carolinum Zahnärztliches Universitäts-Institut gGmbH, Johann Wolfgang Goethe Universität Frankfurt0 个研究点目标入组 25 人开始时间: 2019年9月27日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 69 Years（—）
- 性别
- All
入选标准
- •Being in need of at least one implant for the replacement of missing or non retainable teeth in the upper or lower jaw (in regions 16 to 26 or in the lower jaw in regions 36 to 46, excluding regions 12 and 22 as well as 32,31,42 and 41 FDI (narrow gaps), due to diameter limitations of the implant investigated)
- •- Adjacent teeth and/or implants have to be free of acute or chronical infections (e.g. periodontal or endodontic problems,peri-implantitis)
- •- Single tooth gaps (i.e. natural tooth roots or implants present on the sides adjacent to the implant)
- •- Opposing dentition must be natural teeth or fixed restoration
- •- Subject shall have a stable occlusal relationship
- •- Patient has been informed of the follow-up visits and is willing to return to the clinical center for these follow-up visits
- •- Subjects must have voluntarily signed the informed consent form before any study related action
排除标准
- •- Systemic disease that would interfere with dental implant therapy (e.g. uncontrolled 1. diabetes)
- •- Any contraindications for oral surgical procedures (according to instruction for use of implant system)
- •- Patients who smoke >10 cigarettes per day or cigar equivalents, or who chew Tobacco
- •- Bone metabolism disorders
- •- Uncontrolled para-functional diseases (bruxism, clenching or grinding of teeth)
- •- Disorders that impede the ability of patients to maintain adequate oral hygiene
- •- 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
- •- Any patient with placed implant that cannot be immediately provisionalized or receive an individual healing abutment and need to be submerged healed
- •- Need of extended bone augmentation before or during implant placement
- •- Pregnant or breastfeeding women
研究者
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