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One-piece zirconia implants restored with three-unit all-ceramic fixed dental prostheses on maxillary and mandibular posterior teeth. A prospective clinical multicentric study.

One-piece zirconia implants restored with three-unit all-ceramic fixed dental prostheses on maxillary and mandibular posterior teeth. A prospective clinical multicentric study. - PROSEC Multicentric Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00030380
Enrollment
40
Registered
2022-10-10
Start date
2022-07-17
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

ICD-10-GM K10. 9 Bone quality: 1, 2, 3 or 4 according to Lekholm & Zarb. Bone quantity: A-E according to Lekholm & Zarb. Papilla index (Jemt) Modified Plaque Index (mPI) (Mombelli et al.) Modified Sulcular Bleeding Index (mBI) (Mombelli et al.) Probing depth (PD), mm Clinical attachment level (CAL), mm K10.9

Interventions

Group 1: The planned measures/examination methods are routinely performed as part of any therapy with implants. First, planning is performed on the basis of clinical and radiographic findings. This

Sponsors

Charité Campus Benjamin Franklin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Patients with the following planning findings are restored with implants: - The intraoral condition of the patient shows a dentition with the need for a three-unit end abutment bridge. - Internal sinus lift up to 2mm allowed. - Min. implant length 8mm. - Extraction at least 3 months ago. Only early implant placement (3 - 6 months post extraction) and late implant placement (> 6 months post extraction). - Lateral bone augmentations are possible simultaneously during the surgical procedure. - The patient demonstrates good oral hygiene and compliance. - A pre-implant hygiene phase and or pa treatment must be completed.

Exclusion criteria

Exclusion criteria: - Persons under 18 or persons lacking legal capacity. - Untreated acute periodontitis with pocket depths > 4 mm. - Heavy smokers (more than 10 cigarettes per day). - Taking bisphosphonates or rank ligand inhibitors (Denuso-map) or other drugs affecting bone metabolism (e.g. Cor-tison). - Pregnant women. - Alcohol or drug abusers. - Patients with an infectious disease such as hepatitis or HIV or AIDS. - Patients with severe, uncontrolled diabetes. - Immediate implantations. - Patients with signs of bruxism. - Patients who require an internal sinus lift > 2 mm or an external sinus lift for implantation of a ceramic.implant CI due to bone resorption.

Design outcomes

Secondary

MeasureTime frame
Survey of the survival rate of ceramic implants ceramic.implant CI. Survey of survival rates and success rates (USPHS alpha and bravo) of three-unit fixed dental prostheses on ceramic implants (ceramic.implant CI).

Primary

MeasureTime frame
Survey of the success rate of ceramic implants ceramic.implant CI. The statistical evaluation of the primary endpoint "peri-implant bone loss" is performed after data collection (approx. 5 years) by a linear mixed model with fixed and random intercept. From this model, the two-sided 95% confidence interval is calculated for the fixed intercept. If the upper limit of this confidence interval is below the non-inferiority limit of 1.09 mm, the null hypothesis is rejected and the non-inferiority of zirconia implants over titanium implants is claimed.

Countries

Germany

Contacts

Public ContactLuisa Valentina Kohnen

Abteilung für Zahnärztliche Prothetik, Alterszahnmedizin und Funktionslehre

luisa-valentina.kohnen@charite.de030450662527

Outcome results

None listed

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