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

NCT06513767 | Not Yet Recruiting

• 1 other identifier: F2024-006-1
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dental Prosthesis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Survival rate

  Day 180

• Success rate

  Day 180, Day 360

• Prostheses quality

  Day 0, Day 180, Day 360

• Subject satisfaction

  Day 0, Day 180, Day 360

Study Arms (1)

Investigational group

EXPERIMENTAL

Use of the investigational device (zirconia dental ceramic) to perform dental restorations

Device: Zirconia Dental Ceramics

Interventions

Zirconia Dental Ceramics DEVICE

This investigation was conducted by enrolling subjects who met the enrolment criteria, using the investigational device (Zirconia Dental Ceramics) to perform dental prosthesess.

Investigational group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suzhou Kerui Medical Technology Co., Ltd: lead
• SHENZHEN XIANGTONG CO., LTD: collaborator

Central Study Contacts

Shifeng Fan

CONTACT

15613180638; 174254919@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 22, 2024
• Study Start: August 15, 2024
• Primary Completion: November 1, 2025
• Study Completion: December 20, 2025
• Last Updated: July 22, 2024

Record last verified: 2024-07