DRKS00016500已完成未知
Prospective clinical study to evaluate the clinical performance of immediately placed PL implants: A monocenter study - PL study
Johann Wolfgang Goethe Universität FrankfurtZentrum der Zahn-, Mund- und KieferheilkundeCarolinum Zahnärztliches Universitäts-Institut gGmbHPoliklinik für Zahnärztliche Chirurgie und Implantologie0 个研究点目标入组 25 人开始时间: 2019年1月8日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 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
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 69 Years（—）
- 性别
- All
入选标准
- •1. Males and females with an age of 18 to 69 years
- •2. Planned single tooth replacement in maxilla (14-24 FDI) allowing the placement of a single implant
- •3. Adjacent teeth have to be free of acute or chronical infections (e.g. periodontal or endodontic problems)
- •4. Single tooth gaps (i.e. natural tooth roots present on the sides adjacent to the implant)
- •5. Opposing dentition must be natural teeth or fixed restoration
- •6. Subject shall have a stable occlusal relationship
- •7. Patient has been informed of the follow-up visits and is willing to return to the clinical center for these follow-up visits
- •8. Subjects must have voluntarily signed the informed consent form before any study related action
排除标准
- •1. Systemic disease that would interfere with dental implant therapy (e.g. uncontrolled diabetes)
- •2. Any contraindications for oral surgical procedures (according to instruction for use of implant system)
- •3. Patients who smoke >10 cigarettes per day or cigar equivalents, or who chew tobacco
- •4. Bone metabolism disorders
- •5. Uncontrolled para-functional diseases (bruxism, clenching or grinding of teeth)
- •6. Disorders that impede the ability of patients to maintain adequate oral hygiene
- •7. 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
- •8. Any implant that cannot be immediately provisionalized or receive an individual healing abutment and need to be submerged healed will be excluded from the study
- •9. Pregnant or breastfeeding women
研究者
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