Prospective Clinical Series With Zirconia Implants
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Cumulative Survival Rate (CSR)
研究概览
简要总结
This study is a prospective case series clinical study to examine the effectiveness of Ceramic dental implants manufactured by Swiss Dental Solutions (SDS). Participants with an indication from the dentist for teeth extraction and replacement are invited to participate in this study. Participating in this study will involve the use of dental implants manufactured by Swiss Dental Solutions (SDS zirconia dental implants), submission of the case data, including pre-operative information, intra-operative details, and post-operative follow-up data, to the study site and its collaborating partners.
The SDS zirconia dental implants used in this research are FDA cleared devices that are available for dental treatments.
详细描述
To evaluate the effectiveness of one-piece ceramic implants placed into fresh extraction sockets and provide practical clinical evidence, the investigators will assess their performance in defined clinical settings, encompassing a variety of clinical situations, patients, and practitioners. This evaluation, conducted according to a precise surgical and treatment protocol, considers factors such as patient and clinician variability and long-term outcomes in routine clinical practice.
Study Question:
The cumulative survival rate (CSR), Marginal Bone Level (MBL) and Pink Esthetic Score (PES) of one-piece ceramic implants supporting crowns during a 12-month follow-up period will be determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The need for implant placement in position of single or multiple teeth to be extracted and to replace up to 3 teeth
- •Availability of patient for a minimum follow-up of one year following implantation
- •Availability of complete follow-up data in medical records
- •Availability of post-operative and follow-up periapical radiographs
排除标准
- •History of head and neck irradiation
- •History of bisphosphonate or medications that induce osteonecrosis of the jaw
- •Untreated systemic diseases that are known to affect wound healing, such as uncontrolled diabetes mellitus
- •Immunocompromised or immunoproliferative diseases
- •Heavy Smoking of >10 cigarettes per day
研究组 & 干预措施
Immediate loading of ceramic implants
Tooth/teeth are extracted with minimally invasive approach using piezo surgery and when necessary sectioning after local anesthesia (Articaine 40 mg/mL with epinephrine 10 μg/mL; or Lidocaine 20mg/ml with 10 ug/ml). Extraction sockets are thoroughly degranulated to remove all remnants of soft tissue and residual restorations or material which may have extended beyond the tooth apex. After copious irrigation, the socket condition is recorded, which includes, thickness and location of buccal/facial crestal alveolar bone.
干预措施: Immediate dental implants placements on fresh sockets after tooth extraction (Procedure)
结局指标
主要结局
Cumulative Survival Rate (CSR)
时间窗: 12-month follow-up
The cumulative survival rate is determined as the percentage of implants that remained in place over the observation period for each patient. 100% of survival is defined as absence of implant loss.
次要结局
- Marginal Bone Loss (MBL)(12-month follow-up)