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Clinical Evaluation of Chairside CAD/CAM Nano-ceramic Restorations

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01464294
Recruitment Status : Terminated (not a required sutudy to be posted)
First Posted : November 3, 2011
Last Update Posted : January 27, 2015
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment
Restoration of Posterior Teeth Device: Milled ceramic restorations Device: Milled nano-composite restorations

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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Clinical Evaluation of Chairside CAD/CAM Nano-ceramic Restorations
Study Start Date : October 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Group/Cohort Intervention/treatment
crowns and onlays
Device: Milled nano-composite restorations
Restoration of back teeth with milled crowns or onlays
Other Name: Lava Ultimate CAD/CAM Restorative (3M ESPE)

crowns & onlays
Device: Milled ceramic restorations
Restoration of back teeth with milled ceramic crowns or onlays
Other Name: Empress CAD/CAM leucite porcelain (Ivoclar Vivadent)

Primary Outcome Measures :
  1. clinical performance [ Time Frame: 3 years ]
    Subjective evaluation of restorations using USPHS criteria

Secondary Outcome Measures :
  1. Luting cement [ Time Frame: 3 years ]
    Subjective evaluaton of performance of a nano-filled resin luting cement used to cement the study onlays

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01464294

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United States, Michigan
School of Dentistry, Unversity of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
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Principal Investigator: Dennis Fasbinder, DDS School of Dentistry, Univ of Michigan
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Responsible Party: 3M Identifier: NCT01464294    
Other Study ID Numbers: 3M ESPE CR-10-019
First Posted: November 3, 2011    Key Record Dates
Last Update Posted: January 27, 2015
Last Verified: December 2013
Keywords provided by 3M:
composite block
milled restorations