A Clinical Investigation to Evaluate the Safety and Efficacy of Zirconia Ceramic Blocks for Use in Dental Prostheses.
NCT Number: NCT06513767
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dental Prosthesis
Interventions: DEVICE: Zirconia Dental Ceramics
Sponsor: Suzhou Kerui Medical Technology Co., Ltd
Collaborators: SHENZHEN XIANGTONG CO., LTD
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2025-12-20

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:

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.

Primary Outcome Measures: 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., Day 360
Secondary Outcome Measures: Survival rate, Same as the Primary Outcome Measure, Day 180|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., Day 180, Day 360|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., Day 0, Day 180, Day 360|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., Day 0, Day 180, Day 360