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.
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.
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;
Single group
Zirconia Dental Ceramics
DeviceThis investigation was conducted by enrolling subjects who met the enrolment criteria, using the investigational device (Zirconia Dental Ceramics) to perform dental prosthesess.
Survival rate
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.
Survival rate
Same as the Primary Outcome Measure
Success rate
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 corresponding medical images were retained. The relevant prostheses success rate was calculated after completion of the corresponding visits for all subjects. In the absence of interference from external factors (e.g., severe trauma), the prosthesis is considered a success if it is free of any complications over the entire observation period.
Prostheses quality
The quality of the prostheses was evaluated by the treatment investigator based on the actual condition of the prostheses at the time of the subject's follow-up visit and according to United States Public Health Services (USPHS) criteria.Each USPHS criterion was ranked on a scale of A to C, where A = excellent, B = good, C = unacceptable.
Subject satisfaction
The appearance and comfort of the prostheses were evaluated by the subjects according to their own subjective feelings. Visual Analogue Scales (VAS) was used to complete the satisfaction rating by themselves. That is, on a 10cm long scale, "0" represents the most satisfactory and "10" represents the most unbearable.
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Suzhou Care-Real Medical Technology Co., Ltd.
Lead sponsor
SHENZHEN XIANGTONG CO., LTD
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
