Survival of Different Core Build-up Materials

Core Build-up Materials: a Randomized Clinical Study

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.

Study Overview

• Status: Completed
• Conditions: 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 / Plus" 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
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany, 69120
    • Department of Prosthodontics, University of Heidelberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients of the department of porsthodontics, university of heidelberg

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Rebilda DC
Clearfil Core DC / Plus
Multicore Flow

Collaborators and Investigators

• Sponsor: Heidelberg University
• Investigators: Principal Investigator: Peter Rammelsberg, Prof. Dr., Heidelberg University

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 11, 2011
• Primary Completion (ACTUAL): December 19, 2017
• Study Completion (ACTUAL): December 19, 2017

Study Registration Dates

• First Submitted: October 6, 2011
• First Submitted That Met QC Criteria: October 6, 2011
• First Posted (ESTIMATE): October 10, 2011

Study Record Updates

• Last Update Posted (ACTUAL): October 16, 2018
• Last Update Submitted That Met QC Criteria: October 11, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Prosthesis Failure
• Other Study ID Numbers: Proth-003