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rospective, multicenter clinical study of the long-term behavior of VarseoSmile Crownplus crowns (BEGO Bremer Goldschlägerei, Bremen, Germany) in posterior teeth.

rospective, multicenter clinical study of the long-term behavior of VarseoSmile Crownplus crowns (BEGO Bremer Goldschlägerei, Bremen, Germany) in posterior teeth.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00031175
Enrollment
60
Registered
2023-03-13
Start date
2022-03-07
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

Subjects are included who have an indication for a single crown.

Interventions

Group 1: The use of the novel material VarseoSmile Crownplus, which is manufactured in 3D printing. The intervention consists in the restoration of a tooth with a single-tooth crown. This consists o

Sponsors

Johann Wolfgang Goethe-Universität Frankfurt am Main ZZMK Carolinum Zahnärztliches Universitäts-Institut gGmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: In the opinion of the investigator, the patient must be reliable and cooperative and expected to comply with the study procedure. Participation is on a voluntary basis with a signed declaration of consent to participate in the study. There is an indication in the maxillary or mandibular posterior region for crowning the tooth. The antagonistic tooth of the tooth to be crowned is a natural tooth.

Exclusion criteria

Exclusion criteria: Presence of alcohol or drug abuse or patient with a history of substance abuse, medication or alcohol dependence in the previous year. Known unavailability of patient for follow-up. Patient with clinically significant unstable medical or physiologic condition. Female patient during pregnancy, during style-lens. Patient with lack of consent to participate in the study or lack of understanding of the study content and purpose. Uncontrolled pathological processes in the oral cavity / patient with oral infection such as untreated periodontitis or not completed periodontitis therapy. Current or previous participation in a clinical trial that may affect the present study. Involvement in the design and conduct of the study. Known allergies to materials used.

Design outcomes

Primary

MeasureTime frame
The primary endpoint is defined as survival rate of the single-tooth crown. The event of fracture of the crown is used as the endpoint. The retention of the crown in the patient's mouth is decisive for this.

Secondary

MeasureTime frame
The secondary outcome measures are the success rate, the abrasion resistance of the inserted crown and the corresponding opposing tooth, and the oral health-related quality of life (OHIP-14 questionnaire).

Countries

Germany

Contacts

Public ContactSilvia Brandt

Zentrum der Zahn-, Mund und Kieferheilkunde der Goethe-Universität (Carolinum) Carolinum Zahnärztliches Universitäts-Institut gGmbH

brandt@med.uni-frankfurt.de+4969630186230

Outcome results

None listed

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