Evaluation of new zirconia crowns for dental restoration
Clinical Evaluation of Full Contour Zirconia Chairside CAD/CAM Crowns
This study tests a new type of dental crown made from zirconia to see how well it works for patients needing full restorations over two years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ivoclar Vivadent AG Industry-sponsored |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT06173167 on ClinicalTrials.gov |
What this trial studies
This clinical evaluation investigates the performance of a new monolithic zirconia material designed for chairside CAD/CAM crowns. The study involves a randomized, prospective, longitudinal approach where crowns will be luted using either self-adhesive or conventional cement. Participants will have their crowns evaluated over a two-year period to assess durability and effectiveness in restoring dental function. The trial focuses on patients with specific dental conditions requiring full crown restorations.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with specific dental issues such as carious lesions or fractured teeth requiring full crown restorations.
Not a fit: Patients with sensitive teeth, untreated dental diseases, or those who have undergone certain dental procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved dental restoration options that enhance patient outcomes and satisfaction.
How similar studies have performed: Other studies have shown promising results with similar zirconia materials in dental restorations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * at least 18 years of age * 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 a full crown restoration. * tooth should have at least one opposing tooth in occlusion and one adjacent tooth with an intact proximal contact * No more than ten teeth that are endodontically treated may be included in the study, equally divided between the two groups of crowns. 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 Exclusion Criteria: * Sensitive teeth * Teeth with a history of direct or indirect pulp capping procedures * Patients with significant untreated dental disease to include periodontitis and/or rampant caries * Women who self-report that they are possibly pregnant, pregnant, or lactating, as elective dental treatment is not indicated at these times * Patients with a self-reported history of allergies to the materials to be used in the study including composite resin cements or zirconia restorative materials * Patients unable to return for the recall appointments
Where this trial is running
Ann Arbor, Michigan
- University of Michigan School of Dentistry — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Dennis J. Fasbinder, DDS — University of Michigan
- Study coordinator: Dennis J. Fasbinder, DDS
- Email: djfas@umich.edu
- Phone: (734) 647-4450
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.