DRKS00000226已完成未知
Evaluation of a one-piece ceramic implant used for single tooth replacement and three-unit bridge restoration. A cohort clinical trial
Zentrum für ZahnmedizinKlinik für Kronen- und Brückenprothetik, Teilprothetik und zahnärztliche Materialkunde0 个研究点目标入组 60 人开始时间: 2009年10月1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
- 60
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 70 Years（—）
- 性别
- All
入选标准
- •1. Ability to understand the nature of the study and the study related procedures.
- •2. Written informed consent obtained according to international guidelines and local law.
- •3. The subjects must be in the age of 18 to 70 years old.
- •4. The subject must be systemically healthy and have good compliance.
- •5. The subject must be in need of an implant supported partial denture or implant supported single tooth restorations.
- •6. The subjects must have sufficient bone volume and density i.e. an osseous architecture in the implant placement region enough to receive implants of 4.0 mm in diameter and a sufficient amount of bone for placing implants with a length of at least 8 mm.
- •7. The osseous architecture must be such that it is possible to obtain primary implant stability, i.e. final tightening torque of 35-45 Ncm.
- •8. The subject must have a stable occlusal relationship with no pronounced bruxism.
- •9. The implant sites must be free from infection and/or extraction remnants
排除标准
- •1. Alcohol or drug abuse as noted in patient records or in patient history.
- •2. Smoking
- •3. Health conditions, which do not permit the surgical procedure (see section D5).
- •4. Reason to believe that the treatment might have a negative effect on the subject?s total situation (psychiatric problems), as noted in patient records or in patient history.
- •5. The patient has infectious disease, heart disease or disease of the circulatory system, metabolic disease, bone metabolism disorders, disturbance of the hematopoetic system, hematological disorders, wound healing disturbances, disorders of the endocrine system (i.e., uncontrolled diabetes), local (i.e., tumors, ulcers etc) or other contraindications for dental surgery as noted in patient records or in patient history. A female participant is pregnant.
- •6. The subject is not able to give her/his informed consent to participate.
- •7. The need of bone augmentation (e.g. sinus augmentation procedure) before implant installation to obtain a prosthetically correct implantation transversally. However, a minor augmentation procedure to cover exposed threads or interproximal/buccal grafting due to deficient sites is not an exclusion criteria.
- •8. Any disorders in the planned implant area such as previous tumors, chronic bone disease, or previous irradiation.
- •9. Severe bruxism or other destructive habits.
- •10. Immediate insertion (e.g. placement of the implant immediately after extraction)
- •11. Intake of medication that is known to interfere with the objectives of the study and/or are contraindications of the surgical procedure within 2 weeks prior to entry into the study.
- •12. Intake of investigational drugs less than 30 days prior to entry into the study
- •13. Female patients who are pregnant or breast feeding, or female adults of reproductive potential not employing an effective method of birth control (postmenopausal state at least since 2 years, surgically sterile, hysterectomy, or effective contraceptive method until placement of the final prosthetic restoration [condoms for women, diaphragm or contraceptive sponges, intrauterine device, hormonal contraception]).
- •In female adults of reproductive potential, implantation will only be performed if a negative urine pregnancy test result dated 3 to 14 days prior to implantation is documented. Women have to be advised that they must not become pregnant until placement of the final prosthetic restoration.
研究者
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