A Clinical Investigation to Evaluate the Safety and Efficacy of Zirconia Ceramic Blocks for Use in Dental Prostheses.

Not Applicable

Not yet recruiting

• Conditions: Dental Prosthesis
• Interventions: Device: Zirconia Dental Ceramics

• Registration Number: NCT06513767
• Lead Sponsor: Suzhou Kerui Medical Technology Co., Ltd

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:

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.

Detailed Description

The study aims to provide clinical evidence for the use of the investigational product (zirconia dental ceramic) in dental restorations.

Study Timeline

• Study First Submitted: 2024-06-27
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-17
• Last Update Submitted: 2024-07-17
• Study First Posted: 2024-07-22
• Last Update Posted: 2024-07-22
• Study Start: 2024-08-15
• Primary Completion: 2025-11-01
• Study Completion: 2025-12-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Age ≥ 18 years old, gender is not limited;
2. Patients with permanent teeth who were judged by the investigator to be expected to have dental prostheses using zirconia materials;
3. Subjects volunteered and signed an informed consent form.

Exclusion Criteria

1. Allergy to zirconia ceramic materials or a history of extensive allergies;
2. Patients with oral mucosal ulcers;
3. 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;
4. Pregnant or breastfeeding, or those planning to become pregnant during the investigation period;
5. Participation in another clinical investigation within 3 months;
6. Patients with mental disorders and a lack of autonomy;
7. Meets other conditions that, in the opinion of the investigator, make participation in this clinical investigation inappropriate.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Investigational group	Zirconia Dental Ceramics	Use of the investigational device (zirconia dental ceramic) to perform dental restorations

Primary Outcome Measures

Name	Time	Method
Survival rate	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.

Secondary Outcome Measures

Name	Time	Method
Success rate	Day 180, 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 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	Day 0, Day 180, Day 360	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.
Survival rate	Day 180	Same as the Primary Outcome Measure
Subject satisfaction	Day 0, Day 180, Day 360	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.