Clinical Evaluation on the Longevity of Glass Ceramic Based Single Tooth Restorations

March 27, 2025 updated by: Ivoclar Vivadent AG

Retrospective Clinical Study to Investigate the Longevity of Long-term Single Tooth Restorations From IPS e.Max CAD and Press

This retrospective study investigates the longevity of lithium disilicate based glass-ceramic single tooth restorations placed with IPS e.max CAD and IPS e.max Press after a wearing period of more than 15 years. The primary objective is to assess the survival rate of single tooth restorations with IPS e.max CAD and IPS e.max Press after a wearing period of at least 15 years. The secondary objectives are to assess the quality of the single tooth restorations in regard of aesthetic, functional and biological properties.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults recieving indirect single tooth restorations (inlay, onlay, veneer or crown) within the internal clinic of Ivoclar Vivadent AG between 2006 and 2010.

Description

Inclusion Criteria:

  • Age: > 18 years
  • Informed consent signed and understood by the subject
  • Received indirect single tooth restoration (inlay, onlay, veneer or crown) within the internal clinic of Ivoclar Vivadent AG between 2006 and 2010
  • Single tooth restoration was done with IPS e.max CAD or IPS e.max Press
  • Able to visit the internal clinic of Ivoclar Vivadent AG in Schaan, FL.

Exclusion Criteria:

  • Health status (physical and mental) does not allow participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Single tooth restoration with IPS e.max
Examination of single tooth restorations with IPS e.max after a wearing time of more than 15 years.
Device: Single tooth restoration with IPS e.max
Examination of single tooth restorations with IPS e.max after a wearing time of more than 15 years. Intraoral situation will be examined similar to a standard dental examination while single tooth restorations will be documneted by photos.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival Rate of single tooth restorations
Time Frame: 15 years
Study population recieved single tooth restorations with IPS e.max between 2006-2010. After a wearing time of more than 15 years IPS e.max single tooth restorations were examined by a dentist resulting in survival rates of IPS e.max single tooth restorations after 15 years.
15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ivoclar Vivadent AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

March 13, 2025

First Submitted That Met QC Criteria

March 20, 2025

First Posted (Actual)

March 27, 2025

Study Record Updates

Last Update Posted (Actual)

April 2, 2025

Last Update Submitted That Met QC Criteria

March 27, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OTCS 350528136

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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