A Prospective, Multicentre, Single-group, Target-value Clinical Investigation Evaluating the Safety and Efficacy of Zirconia Ceramic Blocks for All-ceramic Dentures for Use in Dental Prostheses.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- Survival rate
研究概览
简要总结
The goal of this clinical trial is to use the investigational device (Zirconia Dental Ceramics) to perform dental prosthesis in Patients with permanent teeth. The main question it aims to answer is:
Is the safety and efficacy of the investigational device (Zirconia Dental Ceramics) adequate to meet the requirements for clinical use?
Participants will use the investigational device (Zirconia Dental Ceramics) to perform dental prosthesis and then complete a 12-month follow-up after prostheses. During the follow-up period，participants will assess their satisfaction，while the investigator will assess the efficacy indices of prosthesis survival rate, prosthesis success rate and prosthesis quality.
详细描述
The study aims to provide clinical evidence for the use of the investigational product (zirconia dental ceramic) in dental restorations.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old, gender is not limited;
- •Patients with permanent teeth who were judged by the investigator to be expected to have dental prostheses using zirconia materials;
- •Subjects volunteered and signed an informed consent form.
排除标准
- •Allergy to zirconia ceramic materials or a history of extensive allergies;
- •Patients with oral mucosal ulcers;
- •Patients presents with a significant, uncontrolled, systemic disease, encompassing, but not limited to, cardiovascular disease, endocrine or metabolic disease, and immune system disease, among others;
- •Pregnant or breastfeeding, or those planning to become pregnant during the investigation period;
- •Participation in another clinical investigation within 3 months;
- •Patients with mental disorders and a lack of autonomy;
- •Meets other conditions that, in the opinion of the investigator, make participation in this clinical investigation inappropriate.
结局指标
主要结局
Survival rate
时间窗: Day 360
Evaluation was performed by the treatment investigator based on the actual condition of the prostheses at the time of the subject's follow-up visit (in the event that multiple prostheses are present, the most unfavourable outcome is considered), and the appropriate medical images were retained. prostheses survival was calculated after completion of the D360 visit for all subjects. In the absence of interference from external factors (e.g., severe trauma), the prostheses are considered to be survivors if they remain in situ, with or without modification, throughout the observation period.
次要结局
- Success rate(Day 180, Day 360)
- Prostheses quality(Day 0, Day 180, Day 360)
- Survival rate(Day 180)
- Subject satisfaction(Day 0, Day 180, Day 360)