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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01449903
Other study ID # Proth-003
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 11, 2011
Est. completion date December 19, 2017

Study information

Verified date October 2018
Source Heidelberg University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date December 19, 2017
Est. primary completion date December 19, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Department of prosthodontics, university of heidelberg Heidelberg

Sponsors (1)

Lead Sponsor Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

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