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

Suzhou Kerui Medical Technology Co., Ltd

Status: Not yet enrolling

Conditions: Dental Prosthesis

Treatments: Device: Zirconia Dental Ceramics

Study type: Interventional

Funder types: Other

Identifiers

NCT06513767

F2024-006-1

Details and patient eligibility

About

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.

Full description

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

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Investigational group

Experimental group

Description:

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

Treatment:

Device: Zirconia Dental Ceramics