Status:
NOT_YET_RECRUITING
A Clinical Investigation to Evaluate the Safety and Efficacy of Zirconia Ceramic Blocks for Use in Dental Prostheses.
Lead Sponsor:
Suzhou Kerui Medical Technology Co., Ltd
Collaborating Sponsors:
SHENZHEN XIANGTONG CO., LTD
Conditions:
Dental Prosthesis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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: ...
Detailed Description
The study aims to provide clinical evidence for the use of the investigational product (zirconia dental ceramic) in dental restorations.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 20 2025
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06513767
Start Date
August 15 2024
End Date
December 20 2025
Last Update
July 22 2024
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