Survival of Different Core Build-up Materials

NCT ID: NCT01449903

Last Updated: 2018-10-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-07-11
• Study Completion Date: 2017-12-19

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.

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.

Conditions

Dental Prosthesis Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Rebilda DC

No interventions assigned to this group

Clearfil Core DC / Plus

No interventions assigned to this group

Multicore Flow

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heidelberg University

OTHER

Sponsor Role: lead

Responsible Party

Brigitte Ohlmann

PD Dr. med. dent. Brigitte Ohlmann

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter Rammelsberg, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Heidelberg University

Locations

Department of prosthodontics, university of heidelberg

Heidelberg, , Germany

Countries

Germany

Other Identifiers

Proth-003

Identifier Type: -

Identifier Source: org_study_id