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Clinical Evaluation of Chairside CAD/CAM Nano-ceramic Restorations

This study has been terminated.
(not a required sutudy to be posted)
Information provided by (Responsible Party):
3M Identifier:
First received: October 27, 2011
Last updated: January 26, 2015
Last verified: December 2013
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 Intervention
Restoration of Posterior Teeth Device: Milled ceramic restorations Device: Milled nano-composite restorations

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Clinical Evaluation of Chairside CAD/CAM Nano-ceramic Restorations

Further study details as provided by 3M:

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

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

Enrollment: 120
Study Start Date: October 2011
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01464294

United States, Michigan
School of Dentistry, Unversity of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
Principal Investigator: Dennis Fasbinder, DDS School of Dentistry, Univ of Michigan
  More Information

Responsible Party: 3M Identifier: NCT01464294     History of Changes
Other Study ID Numbers: 3M ESPE CR-10-019
Study First Received: October 27, 2011
Last Updated: January 26, 2015

Keywords provided by 3M:
composite block
milled restorations processed this record on September 21, 2017