Survival of Different Core Build-up Materials

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01449903
Recruitment Status : Recruiting
First Posted : October 10, 2011
Last Update Posted : November 1, 2017
Information provided by (Responsible Party):
Brigitte Ohlmann, Heidelberg University

Brief Summary:
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.

Condition or disease
Dental Prosthesis Failure

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.

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Core Build-up Materials: a Randomized Clinical Study
Study Start Date : January 2012
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Rebilda DC
Clearfil Core DC
Multicore Flow

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Brigitte Ohlmann, PD Dr. med. dent. Brigitte Ohlmann, Heidelberg University Identifier: NCT01449903     History of Changes
Other Study ID Numbers: Proth-003
First Posted: October 10, 2011    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Prosthesis Failure
Postoperative Complications
Pathologic Processes