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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSuzhou Care-Real Medical Technology Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Zirconia Dental Ceramics

Treatment groups

150 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

Suzhou Care-Real Medical Technology Co., Ltd.

Lead sponsor

SHENZHEN XIANGTONG CO., LTD

Collaborator