NCT03452358

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 2, 2018

Completed
Last Updated

March 6, 2018

Status Verified

March 1, 2018

Enrollment Period

3.1 years

First QC Date

February 26, 2018

Last Update Submit

March 3, 2018

Conditions

SurvivalImmediate Dentin Sealing

Outcome Measures

Primary Outcomes (1)

  • Survival rate

    from 2006 to 2018

Secondary Outcomes (1)

  • Quality of survival

    from 2006 to 2018

Interventions

Partial Ceramic Indirect restorationPROCEDURE

Placement of an partial ceramic indirect restoration with the use of immediate dentin sealing as an adjunct to adhesive cementation.

Also known as: Immediate Dentin Sealing

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • No patients will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 26, 2018

First Posted

March 2, 2018

Study Start

January 1, 2015

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

March 6, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share