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

NCT ID: NCT06513767

Last Updated: 2024-07-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-15
• Study Completion Date: 2025-12-20

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.

Conditions

Dental Prosthesis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Investigational group

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

Group Type: EXPERIMENTAL

Zirconia Dental Ceramics

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SHENZHEN XIANGTONG CO., LTD

UNKNOWN

Sponsor Role: collaborator

Suzhou Kerui Medical Technology Co., Ltd

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Shifeng Fan

Role: CONTACT

174254919@qq.com

15613180638

Other Identifiers

F2024-006-1

Identifier Type: -

Identifier Source: org_study_id