Comparative Performance of Zirconia Tissue Level Implants vs. Titanium Bone Level Implants Placed With a Fully Digital Workflow: A Multicentre Multinational Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 3
- 主要终点
- Bone Level Change
研究概览
简要总结
A post-market, multi-centre, prospective, open, randomized-controlled, non-inferiority clinical study to compare short-term performance and safety of the Straumann PURE 2-piece Ceramic Implant with Straumann Bone Level Implant using a fully digital workflow.
详细描述
To compare short-term performance and safety of the Straumann PURE 2-piece Ceramic Implant with Straumann Bone Level Implant using a fully digital workflow. Post-market, multi-centre, prospective, open, randomized-controlled, non-inferiority clinical study investigating patients in need of dental implant therapy for single-tooth gap rehabilitation. The follow up time is1 year after final crown restoration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 must have voluntarily signed the Informed Consent Form before any study related procedures are performed, are willing and able to attend scheduled follow-up visits and agree that the pseudonymized data will be collected, analysed, and published.
- •Patients must be males or females who are a minimum of 18 years of age.
- •Patients, who are in need of a single tooth replacement with a dental implant in the premolar-to-premolar area in the mandible or maxilla (excluding lower incisors).
- •Presence of natural teeth on both sides of the study implant position and opposing dentition (single tooth gap).
- •Patients with healed extraction sockets, which means that at implant surgery:
- •Soft tissue coverage of the socket is complete; and
- •Alveolar bone is reconsolidated (around 16 weeks after tooth extraction).
排除标准
- •Patients with inadequate bone volume where major bone augmentation would be required at implant location.
- •Inadequate anatomic situation that would prevent prosthetic-driven planning based on CBCT.
- •Presence of implants neighbouring the study implant.
- •Patients with inadequate oral hygiene (FMPS ≥ 20%).
- •Patients with local root remnants.
- •Patients with inadequate wound healing capacity.
- •Patients with incomplete maxillary and mandibular growth.
- •Patients with medical contraindications to implant surgery (uncontrolled bleeding disorders, psychoses, prolonged therapy-resistant functional disorders, xerostomia, weakened immune system, illnesses requiring periodic use of steroids or uncontrollable endocrine disorders.
- •Patients with drug or alcohol abuse.
- •Patients with allergies or hypersensitivity to zirconium oxide (ZrO2), yttrium oxide (Y2O3), hafnium dioxide (HfO2), aluminium oxide (Al2O3), and titanium (Grade 4).
- •Patients with medical contraindications to implant surgery (uncontrolled bleeding disorders, psychoses, prolonged therapy-resistant functional disorders, xerostomia, weakened immune system, illnesses requiring periodic use of steroids or uncontrollable endocrine disorders).
- •Patients with 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.
- •Pregnancy or intention to become pregnant at any point during the study duration.
- •Furthermore, patients with uncontrolled periodontitis and less than 3 mm of keratinized mucosa at the day of surgery will be excluded from the study. Controlled periodontitis is defined as treated periodontitis with two or less pockets that are < 4 mm in depth or the existence of ≤ 20% bleeding on probing.
- •If the planned implant position is the second premolar, the adjacent molar must be present. Shortened arches with missing molars are not eligible in such a case.
研究组 & 干预措施
Study Group (SG)
Receive new zirconia implant: Straumann® PURE 2-piece Ceramic Implant (tissue level), ZLA
干预措施: Ceramic Dental Implant (Device)
Control Group (CG)
Receive standard titanium implant: Straumann® Bone Level Implant, Titanium, SLA
干预措施: Titanium Dental Implant (Device)
结局指标
主要结局
Bone Level Change
时间窗: 12 months after implant loading (final crown restoration)
Change in crestal bone level measured by analysis of standardized peri-apical xrays 12 months after loading \[mm\].
次要结局
- Implant survival(12 months after loading.)
- 14 item Oral Health Impact Profile (OHIP-14)(12 months after loading.)