Survival of Different Core Build-up Materials

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2011 by Heidelberg University
Sponsor:
Information provided by (Responsible Party):
Brigitte Ohlmann, University of Heidelberg
ClinicalTrials.gov Identifier:
NCT01449903
First received: October 6, 2011
Last updated: October 10, 2011
Last verified: October 2011
  Purpose

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
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 Heidelberg University:

Estimated Enrollment: 300
Study Start Date: November 2011
Estimated Study Completion Date: November 2016
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients of the department of porsthodontics, university of heidelberg

Criteria

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 ClinicalTrials.gov identifier: NCT01449903

Contacts
Contact: Brigitte Ohlmann, PD Dr. 0049-6221-5637573 Brigitte_Ohlmann@med.uni-heidelberg.de

Locations
Germany
Department of prosthodontics, university of heidelberg Not yet recruiting
Heidelberg, Germany, 69120
Sub-Investigator: Andreas Zenthoefer         
Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Peter Rammelsberg, Prof. Dr. Heidelberg University
  More Information

No publications provided

Responsible Party: Brigitte Ohlmann, PD Dr. med. dent. Brigitte Ohlmann, University of Heidelberg
ClinicalTrials.gov Identifier: NCT01449903     History of Changes
Other Study ID Numbers: Proth-003
Study First Received: October 6, 2011
Last Updated: October 10, 2011
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Prosthesis Failure
Pathologic Processes
Postoperative Complications

ClinicalTrials.gov processed this record on October 20, 2014