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Survival of Different Core Build-up Materials

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2015 by Brigitte Ohlmann, Heidelberg University.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Brigitte Ohlmann, Heidelberg University Identifier:
First received: October 6, 2011
Last updated: May 27, 2015
Last verified: May 2015
The purpose of this study is to compare three different core build-up materials for dental use. The study hypothesis is that there is no differences in survival rate of the different core build-ups.

Dental Prosthesis Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Core Build-up Materials: a Randomized Clinical Study

Further study details as provided by Brigitte Ohlmann, Heidelberg University:

Estimated Enrollment: 300
Study Start Date: January 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Rebilda DC
Clearfil Core DC
Multicore Flow

Detailed Description:
Core build-ups replace dental structures which are decayed through caries or tooth fractures. Often there are necessary before insertion of dental restorations. In clinical practice, there are two main material groups: glass ionomer cements and composites. Because of there good physical properties the composite materials claimed to fulfill the expected criteria of core build-ups. However, some of these composite core build-ups get lost before insertion of definite prosthetic restorations. The current prospective, randomized controlled study should investigate the survival rate of three different composite materials: "Rebilda DC", "Clearfil Core DC" and "Multicore Flow". The statistical analysis will performed with logistic regression performed by the institute of institute of Medical Biometry and Informatics, university of heidelberg. The study hypothesis is that there is no differences in the survival rate.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients of the department of porsthodontics, university of heidelberg

Inclusion Criteria:

  • patients need a single crown or fixed dental prostheses
  • patients are able to signed inform consent form, more than 18 years,

Exclusion Criteria:

  • no pregnant women
  • insufficient oral hygiene
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01449903

Contact: Brigitte Ohlmann, PD Dr. 0049-6221-5637573

Department of prosthodontics, university of heidelberg Recruiting
Heidelberg, Germany, 69120
Sub-Investigator: Andreas Zenthoefer, Dr         
Sponsors and Collaborators
Heidelberg University
Principal Investigator: Peter Rammelsberg, Prof. Dr. Heidelberg University
  More Information

Responsible Party: Brigitte Ohlmann, PD Dr. med. dent. Brigitte Ohlmann, Heidelberg University Identifier: NCT01449903     History of Changes
Other Study ID Numbers: Proth-003
Study First Received: October 6, 2011
Last Updated: May 27, 2015

Additional relevant MeSH terms:
Prosthesis Failure
Postoperative Complications
Pathologic Processes processed this record on August 23, 2017