Survival Rate of Lithium Disilicate Crowns

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

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.

Study Overview

• Status: Completed
• Conditions: Survival; Immediate Dentin Sealing
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 170

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients participating in this study will be recruited from the patient population of the private dental practice 'Buijs tandartsen' in Groningen, the Netherlands.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Survival rate	from 2006 to 2018

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of survival	according to Hickel	from 2006 to 2018

Collaborators and Investigators

• Sponsor: University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: February 26, 2018
• First Submitted That Met QC Criteria: February 26, 2018
• First Posted (Actual): March 2, 2018

Study Record Updates

• Last Update Posted (Actual): March 6, 2018
• Last Update Submitted That Met QC Criteria: March 3, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 201500391

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No