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Long-term success of two-piece zirconia versus titanium implants. A randomized clinical study on the influence of implant material on clinical and radiographic outcomes after 5 years

Long-term success of two-piece zirconia versus titanium implants. A randomized clinical study on the influence of implant material on clinical and radiographic outcomes after 5 years

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00037435
Enrollment
50
Registered
2025-07-14
Start date
2025-09-05
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Implantation after tooth loss

Interventions

Group 1: Titanium group (n = 25), a two-piece titanium implant is inserted (CAMLOG® Progressive Line [PL], ALTATEC GmbH, Wimsheim, Germany). Group 2: Zirconia group (n = 25), a two-part zirconia impla

Sponsors

Zentrum für Zahnmedizin Prof. Dr. Schnutenhaus MVZ GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Gaps in the upper jaw in the area of the premolars, canines and anterior teeth - Free-end situations in the upper jaw with premolars, canines or anterior teeth to be replaced - The extraction of the teeth in question took place at least three months ago. - Only early implantations (3-6 months post extraction) or late implantations (> 6 months post extraction) are performed. - The patient demonstrates good oral hygiene and sufficient compliance. - A pre-implant hygiene treatment was successfully completed. - A written declaration of consent from the patient is available.

Exclusion criteria

Exclusion criteria: - Persons under the age of 18 or persons lacking legal capacity - Patients with untreated, acute periodontitis (pocket depth > 4 mm) - Heavy smokers (more than 10 cigarettes per day) - Patients taking bisphosphonates - Pregnant women - Alcohol or drug addicts - Patients with infectious diseases such as hepatitis, HIV or AIDS - Patients with diabetes mellitus that is difficult to control - Immediate implantations - Primarily recognizable need for augmentation - Single tooth gaps with a mesio-distal width > 6.8 mm

Design outcomes

Primary

MeasureTime frame
- Implant loss within an observation period of five years after insertion, differentiated according to the two implant materials.

Secondary

MeasureTime frame
- Occurrence of biological and technical complications (material-dependent) - Bone remodeling (radiologically determined using standardized x-rays) - Pink Esthetic Score (PES) - Patient satisfaction (Patient-Reported Outcome Measures, PROMs) - Pain perception in the first week after implant placement (visual analog scale, VAS) - Differences in clinical parameters: o Bleeding on probing (BOP) o Probing depths / attachment level (ATL) o Papilla index according to Jemt o Modified plaque index according to Mombelli - Concentration of the inflammatory marker a-MMP-8 in the peri-implant sulcus fluid - Primary and secondary implant stability (measured using resonance frequency analysis and determination of ISQ values at the time of insertion and before prosthetic restoration) - Accuracy of implant position with navigated insertion - Clinical results of zirconia hybrid abutment crowns in terms of survival rate and technical complications.

Countries

Germany, Switzerland

Contacts

Public ContactSigmar Schnutenhaus

Zentrum für Zahnmedizin Prof. Dr. Schnutenhaus MVZ GmbH

info@schnutenhaus.de+497731182755

Outcome results

None listed

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