Survival Rate of Lithium Disilicate Crowns

Sponsor

University Medical Center Groningen (Other)

Overall Status

Completed

CT.gov ID

NCT03452358

Collaborator

(none)

170

Enrollment

Actual Duration (Months)

Study Details

Study Description

Brief Summary

A retrospective clinical study will be performed evaluating a large number of partial ceramic restorations (IPS e-Max press, Ivoclar, Liechtenstein) placed in general practice. Evaluation will be based on the well established Hickel criteria (Hickel et al, 2010). Rationale: IPS-e-max press has been made available to the market since 2006. Although millions of these restorations have been placed worldwide, clinical data are available of less than 200 single restorations only, covering observation periods of 2-8 years.(Guess et al, 2009; Etman en Woolford, 2010; Gehrt et al, 2012; Esquivel-Upshaw et al, 2012).

Objective: Study the survival of lithium disilicate restorations during regular check-ups in a private dental practice.

Condition or Disease	Intervention/Treatment	Phase
Survival Immediate Dentin Sealing	Procedure: Partial Ceramic Indirect restoration

Detailed Description

Study the survival of lithium disilicate restorations during regular check-ups in a private dental practice. All included patients were followed-up with special emphasis on the partial restoration(s), every time they visited the dental practice for regular dental check-ups between 2015 and 2017. To assess these restorations a light photograph with a digital camera (Nikon (D7100, 60mm lens), Nikon, Amsterdam, The Netherlands) and an x-ray were taken from the partial posterior crowns and evaluated according to the modified United States Public Health Service (USPHS) criteria.

Study Design

Study Type:

Observational

Actual Enrollment :

170 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Clinical Evaluation of Partial Ceramic Posterior Restorations Cemented Using Immediate Dentin Sealing - a (#) Year Follow up From a Retrospective Study.

Actual Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Feb 1, 2018

Actual Study Completion Date :

Feb 1, 2018

Outcome Measures

Primary Outcome Measures

Survival rate [from 2006 to 2018]

Secondary Outcome Measures

Quality of survival [from 2006 to 2018]
according to Hickel

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

In order to be eligible to participate in this study, a patient must received one or more lithium disilicate restorations between 2006 and today.

Exclusion Criteria:

No patients will be excluded from the study.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University Medical Center Groningen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Carline van den Breemer, Principal Investigator, University Medical Center Groningen

ClinicalTrials.gov Identifier:

NCT03452358

Other Study ID Numbers:

201500391

First Posted:

Mar 2, 2018

Last Update Posted:

Mar 6, 2018

Last Verified:

Mar 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 6, 2018