Clinical Evaluation of Chairside CAD/CAM Nano-ceramic Restorations

November 27, 2024 updated by: Solventum US LLC
Study aim is to test whether nano-composite CAD/CAM milled restorations have a similar performance in clinical service to conventional ceramic CAD/CAM restorations.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

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

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • School of Dentistry, Unversity of Michigan

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients attending and/or under clinical treatment at the University of Michigan Dental Clinics

Description

Inclusion Criteria:

  • Patient 18 years of age or over
  • To have at least one carious lesion or defective restoration in a molar or premolar tooth, cavities to be large enough to warrant a milled restoration of either a crown or onlay
  • Teeth to be vital and asymptomatic

Exclusion Criteria:

  • Devital or sensitive teeth
  • Teeth that have had root canal treatment
  • Patients with significant untreated dental disease including periodontitis and rampant caries
  • Pregnant or lactating women

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
nano-composite
crowns and onlays
Device: Milled nano-composite restorations
Restoration of back teeth with milled crowns or onlays
Other Names:
  • Lava Ultimate CAD/CAM Restorative (3M ESPE)
ceramic
crowns & onlays
Device: Milled ceramic restorations
Restoration of back teeth with milled ceramic crowns or onlays
Other Names:
  • Empress CAD/CAM leucite porcelain (Ivoclar Vivadent)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical performance
Time Frame: 3 years
Subjective evaluation of restorations using USPHS criteria
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Luting cement
Time Frame: 3 years
Subjective evaluaton of performance of a nano-filled resin luting cement used to cement the study onlays
3 years

Collaborators and Investigators

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

Sponsor

Solventum US LLC

Collaborators

3M

Investigators

  • Principal Investigator: Dennis Fasbinder, DDS, School of Dentistry, Univ of Michigan

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

October 1, 2011

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

October 27, 2011

First Submitted That Met QC Criteria

November 2, 2011

First Posted (Estimated)

November 3, 2011

Study Record Updates

Last Update Posted (Estimated)

December 2, 2024

Last Update Submitted That Met QC Criteria

November 27, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 3M ESPE CR-10-019

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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