rospective, multicenter clinical study of the long-term behavior of VarseoSmile Crownplus crowns (BEGO Bremer Goldschlägerei, Bremen, Germany) in posterior teeth.
- Conditions
- Subjects are included who have an indication for a single crown.
- Registration Number
- DRKS00031175
- Lead Sponsor
- Johann Wolfgang Goethe-Universität Frankfurt am Main ZZMK Carolinum Zahnärztliches Universitäts-Institut gGmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
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.
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.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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).