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Prospective randomized controlled interventional study of chair-side generated monolithic single implant supra-structures made of lithium disilicate ceramic

Prospective randomized controlled interventional study of chair-side generated monolithic single implant supra-structures made of lithium disilicate ceramic - Abutment Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00005452
Enrollment
30
Registered
2013-11-19
Start date
2013-11-19
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

dental implant supra-structures as rehabilitation of missing single teeth

Interventions

Group 1: monolithic single implant suprastructures made of lithium disilicate Group 2: titanium abutment and crown made of lithium disilicate

Sponsors

Ivoclar Vivadent AG
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: signed consent, male and female patients >18 years, ASA Physical Status 1 or 2, indication for single implant(s) in the posterior region, abutment height </= 15 mm, antagonists: fixed prosthesis or natural dentition, pocket depth max. 4 mm, good oral hygiene, no treatment needs at adjacent or antagonist teeth, bone augmentation in implant site is no contra indication

Exclusion criteria

Exclusion criteria: restoration height > 15 mm, the minimum thicknesses for the screw canal cannot be obtained, severe diseases like non successfully treated diabetes or hypertension, bisphosphonates, severe smokers, patients with psychological disorders, drug abuse, pregnant or breastfeeding patients, minor patients, patients who are mentally disabled and who are dependent on a legal guardian, patients who are accommodated in a health care institution due to mental disease

Design outcomes

Primary

MeasureTime frame
Survival rate and complication rate over a time period of at least 3 years. Examinations dates: Baseline, annual, clinical examinations: stability of screw retention implant - supra-structure, surface, colour, anatomy, gingiva index, plaque index, PES (Pink Esthetic Score)/WES (White Esthetic Score), periotest measurements, radiologic examinations: x-rays baseline, 12 month, 36 month. measurement of the sulcus fluid rate after one year, photos, intraoral 3D optical impressions

Countries

Germany

Contacts

Public ContactSven Reich

Lehr- und Forschungsgebiet Computergestützte Zahnmedizin in der Klinik für Zahnärztliche Prothetik und Biomaterialien, Zentrum für Implantologie (Direktor: Univ.-Prof. Dr. S. Wolfart)Uniklinik Aachen

sreich@ukaachen.de0241 80 88 241

Outcome results

None listed

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