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Long-term Clinical Performance of Custom-Made Monolithic Zirconia Restorations made of Zolid Gen-X and Zolid Bion in various Indications

Long-term Clinical Performance of Custom-Made Monolithic Zirconia Restorations made of Zolid Gen-X and Zolid Bion in various Indications

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00035232
Enrollment
100
Registered
2024-10-10
Start date
2025-01-31
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Z46.3

Interventions

Group 1: Patients receiving monolithic zirconia restorations made of 4Y-TZP zirconia in various indications. Group 2: Patients receiving monolithic zirconia restorations made of 4Y-/5Y-TZP zirconia in

Sponsors

Medizinische Universität Wien
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients have to meet the following criteria to be included: - need for custom-made tooth- and / or implant-supported single-unit and / or multi-unit fixed dental prostheses in the anterior and / or posterior region due to primary caries (proximal, occlusal, cervical, root, early childhood caries) or non-caries hard tissue defects (e.g., erosive tooth wear, abrasion, fractures/cracks or trauma) or dental developmental disorders (e.g., molar-incisor-hypo mineralization or hereditary disorders of enamel/dentin) or other specific situations, e.g., restorations to im-prove aesthetics due to discoloration or diastemas; and - all gender; patient age 18 to 65 years (reducing the natural mortal risk due to a 10-year timeframe study); and - patient must be informed about the advantages and disadvantages of the different forms of care as well as the possible risks and complica-tions associated with them; and -requirement for patient self-management. The patient must be able to practice adequate oral hygiene and attend regular follow-up appoint-ments.

Exclusion criteria

Exclusion criteria: Patients will not be included in the study if one or more of the following criteria apply: - patients who refuse to participate in the research; - patients who represent systemic conditions or chronic diseases that re-quire differentiated care and follow-up (preapical inflammation and exist-ing periodontitis; insufficient root fillings with imflammation); - pregnant women; - patients with insufficient tooth-structure availability, insufficient prepara-tion, insufficient oral hygiene or heavily discolored hard tooth structure; - under 18 years of age, due to the generally large pulp cavity (exceptions include: adhesive bridges, non-vital teeth, tenon teeth); - patients with more than two contiguous pontics in the posterior region or more than three contiguous pontics in the anterior region; - patients with known incompatibilities with respect to the components.

Design outcomes

Primary

MeasureTime frame
The primary outcome is the survival rate (Kaplan-Meier) of the restorations after 1-, 3-, 5-, 10-years.

Secondary

MeasureTime frame
Secondary endpoints are the technical, biological, and aesthetic performance as well as the patient's satisfaction according to the FDI criteria.

Countries

Austria

Contacts

Public ContactBenedikt Sagl

Medizinische Universität Wien

benedikt.sagl@meduniwien.ac.at+43 1 40070-4204

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026