Clinical Study of a 3D Shaded Zirconia for Chairside CAD/CAM Restorations (NCT06713577) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Clinical Study of a 3D Shaded Zirconia for Chairside CAD/CAM Restorations
United States82 participantsStarted 2024-12-03
Plain-language summary
This investigation will be a prospective, longitudinal clinical trial to study the clinical performance of a new monolithic, 3D shaded zirconia material for computer assisted design and computer assisted machining for chairside restorations. The restorations will be evaluated for a period of up to five years. The study is called Clinical Study of a 3D Shaded Zirconia for chairside computer assisted design and computer assisted machining (CAD/CAM) chairside restorations intended to be part of the validation plan and post market follow-up of the following products: CEREC Cercon 4D, Calibra Universal +, and Prime and Bond Active.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult aged 18-75 years.
* Willing and able to sign and date the informed consent form and the HIPAA form.
* Onlays and Crowns: Each patient should have at least one carious lesion, defective restoration, or fractured portion of the tooth to be restored on a maxillary or mandibular premolar or molar tooth. Each lesion, fracture, or defective restoration should exhibit sufficient size or loss of tooth structure requiring an onlay or crown restoration. The tooth should have at least one opposing tooth in occlusion and one adjacent tooth with an intact proximal contact. No more than eight teeth that are endodontically treated and restorable with an onlay or crown may be included in the study. All remaining teeth in the study will test vital and be asymptomatic at the beginning of treatment. No more than two restorations will be placed per patient. If a patient presents with more than two acceptable teeth for the study, molar teeth will be included prior to premolar teeth.
* Fixed Partial Dentures (FPDs): Each patient should have at least one missing tooth, either anterior or posterior, that is appropriate for replacement with a fixed partial denture. Abutment teeth will have healthy periodontal status with at least a 1:1 crown:root ratio. The FPD should have at least two opposing teeth in occlusion and one adjacent tooth with an intact proximal contact. Both abutment teeth must be asymptomatic prior to treatment. Endodontically treated teeth will be accepta…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluation of the longitudinal clinical performance of 3D shaded zirconia onlays, crowns and FPDs.