A Prospective Open Label Single Arm Study to Evaluate the Performance of Straumann Monotype FullCeram (Zirconium Dioxide) Implants in Single Tooth Gaps in the Maxilla and Mandible
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 3
- 主要终点
- The Implant Survival
研究概览
简要总结
- Straumann Monotype FullCeram implants serve as a suitable alternative for implant therapy especially in the aesthetic zone
- The survival rate of Straumann Ceramic implants should be at least 85% (max 6 implant losses out of 40 patients) after the first year
详细描述
This is a prospective, open label, single arm, multicenter study. The total study duration for each patient was prolonged to 10 years follow-up. It is acceptable to have the visit performed up to 6 month after the aspired date.
The primary study parameter will be analyzed as soon as every patient passed visit 6 (annual follow-up visit, 12 month +/- 4 weeks).
Implants will be placed transmucosally and will be protected by a thermoplastic splint for healing. A provisional prosthesis will be placed (out of occlusion) 12-14 weeks post implant placement. The final crown will be done between study week 24 and 28. Implant survival, implant success, bone loss, periodontal parameters and adverse events will be assessed in the follow-up visits.
In total 10 visits are scheduled in this study. The investigational device: Straumann FullCeram Implant is a monotype ZrO2 implant with a diameter of 4.1 mm, available in lengths of 8, 10, 12 and 14 mm and abutment heights of 4.0 or 5.5 mm. This is a CE marked product.
Three centres in Germany are participating. The study and any amendments will be performed as far as possible according to ISO 14155 (Second Edition, 2011-02-01) and conform to the Declaration of Helsinki (last revised Seoul 2008) and local legal and regulatory requirements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Subject must have voluntary signed the informed consent and the data protection consent form before any study related action
- •Males and females with at least 18 years of age (including 18 years)
- •Implant placement planned in the maxilla or mandible
- •The missing tooth site must have a tooth with a natural root
- •Substantially healed and augmented extraction sockets (minimal 8 weeks)
- •Autogenous bone augmentation until 3 month pre-implantation were bone deficiency jeopardizing the implant position
排除标准
- •Pre-surgical exclusion criteria:
- •Systemic disease that would interfere with dental implant therapy
- •Any contraindications for oral surgical procedures
- •Mucosal diseases
- •History of local irradiation therapy
- •Current untreated periodontitis or gingivitis
- •Any untreated endodontic lesions
- •Probing pocket depth of > or = 4 mm on one of the teeth immediately adjacent to the dental implant site
- •Severe bruxing or clenching habits
- •Patients with inadequate oral hygiene or unmotivated for adequate home care
- •Patients who smoke >10 cigarettes per day or tobacco equivalents or chew tobacco
- •Subjects who have undergone administration of any investigational device within 30 days of enrolment in the study
- •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
- •Physical or mental handicaps that would interfere with the ability to perform adequate oral hygiene
- •Pregnant women at screening
- •Secondary exclusion criteria at or after implant surgery:
- •Lack of primary stability of the implant (hand testing directly after surgery)
- •Inappropriate implant position for the prosthetic requirements (to be estimated before provisional restoration)
- •Major simultaneous augmentation procedures (at surgery)
- •X-ray of implant does not show the implant from first bone contact to apical tip (at surgery)
研究组 & 干预措施
FullCeram implant
Straumann FullCeram Implant is a monotype ZrO2 implant with a diameter of 4.1 mm, available in lengths of 8, 10, 12 and 14 mm and abutment heights of 4.0 or 5.5 mm
干预措施: FullCeram implant (Device)
结局指标
主要结局
The Implant Survival
时间窗: Measured at 12 months +/- 4 weeks after implant placement
A surviving implant is an integrated implant in the patient's jaw bone at the time of assessment.
次要结局
- The Implant Success(Measured at Week 26, Month 12, Month 24 and Month 36)
- Mean Bone Level Changes (Distal and Mesial)(Measured at Week 26, Month 12, Month 24 and Month 36)
- The Implant Survival(Measured at Week 26, Month 24 and Month 36)