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NCT Number: NCT06513767

A Clinical Investigation to Evaluate the Safety and Efficacy of Zirconia Ceramic Blocks 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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Survival rate

    Time frame: Day 360

    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.

Secondary outcomes

  1. Survival rate

    Time frame: Day 180

    Same as the Primary Outcome Measure

  2. Success rate

    Time frame: Day 180, Day 360

    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.

  3. Prostheses quality

    Time frame: Day 0, Day 180, Day 360

    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.

  4. Subject satisfaction

    Time frame: Day 0, Day 180, Day 360

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shifeng Fan

CONTACT

[email protected]

15613180638

Sponsors and collaborators

Lead sponsor

Suzhou Care-Real Medical Technology Co., Ltd.

Other

Collaborators

  • SHENZHEN XIANGTONG CO., LTD

Registry information

Official study title

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.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 22, 2024
Registry last updated
Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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