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

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dental Prosthesis
• Intervention / Treatment: Device: Zirconia Dental Ceramics

Detailed Description

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

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shifeng Fan; Phone Number: 15613180638; Email: 174254919@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational group; Use of the investigational device (zirconia dental ceramic) to perform dental restorations	Device: Zirconia Dental Ceramics; This investigation was conducted by enrolling subjects who met the enrolment criteria, using the investigational device (Zirconia Dental Ceramics) to perform dental prosthesess.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Suzhou Kerui Medical Technology Co., Ltd
• Collaborators: SHENZHEN XIANGTONG CO., LTD

Study record dates

Study Major Dates

• Study Start (Estimated): August 15, 2024
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): December 20, 2025

Study Registration Dates

• First Submitted: June 27, 2024
• First Submitted That Met QC Criteria: July 17, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Actual): July 22, 2024
• Last Update Submitted That Met QC Criteria: July 17, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: F2024-006-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No