Dental ProsthesisNCT06513767
A Clinical Investigation to Evaluate the Safety and Efficacy of Zirconia Ceramic Blocks for Use in Dental Prostheses.
A study testing Zirconia Dental Ceramics in people with Dental Prosthesis, run by Suzhou Care-Real Medical Technology Co., Ltd..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Prosthesis
- What is being tested?
- Zirconia Dental Ceramics
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2024to 20 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official 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.
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.
Read the 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
- Being tested
- Zirconia Dental Ceramics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zirconia Dental CeramicsDevice
This investigation was conducted by enrolling subjects who met the enrolment criteria, using the investigational device (Zirconia Dental Ceramics) to perform dental prosthesess.
| Study group | Role | What they receive |
|---|---|---|
| Investigational group | Experimental | Use of the investigational device (zirconia dental ceramic) to perform dental restorations Receives: Device: Zirconia Dental Ceramics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 360
Secondary outcomes (4)
Survival rate
Same as the Primary Outcome Measure
Measured: Day 180
Success 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 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.
Measured: Day 180, Day 360
Prostheses quality
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.
Measured: Day 0, Day 180, Day 360
Subject satisfaction
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.
Measured: Day 0, Day 180, Day 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start15 Aug 2024 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ProsthesisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Care-Real Medical Technology Co., Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- SHENZHEN XIANGTONG CO., LTD
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513767
- Sponsor's protocol ID
- F2024-006-1
- Status last verified
- Jul 2024
- First submitted
- 27 Jun 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT06513767
- Acronym / sponsor ID
- F2024-006-1
- Conditions
- Dental Prosthesis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Suzhou Care-Real Medical Technology Co., Ltd.University, hospital or other
- Collaborators
- SHENZHEN XIANGTONG CO., LTD
- Study start
- 15 Aug 2024 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigational group | Experimental | Device: Zirconia Dental CeramicsUse of the investigational device (zirconia dental ceramic) to perform dental restorations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zirconia Dental CeramicsThis investigation was conducted by enrolling subjects who met the enrolment criteria, using the investigational device (Zirconia Dental Ceramics) to perform dental prosthesess. | Device | Investigational group |
Primary outcome
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.
4 secondary outcomes
Survival rate
Time frame: Day 180
Success rate
Time frame: Day 180, Day 360
Prostheses quality
Time frame: Day 0, Day 180, Day 360
Subject satisfaction
Time frame: Day 0, Day 180, Day 360
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Zirconia Dental Ceramics in people with Dental Prosthesis, run by Suzhou Care-Real Medical Technology Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shifeng Fan (15613180638, 174254919@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate (time frame: Day 360). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024.