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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)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01464294
First Posted: November 3, 2011
Last Update Posted: January 27, 2015
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.
Information provided by (Responsible Party):
3M
  Purpose
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
nano-composite
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)
ceramic
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)

  Eligibility

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.


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
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT01464294


Locations
United States, Michigan
School of Dentistry, Unversity of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
3M
Investigators
Principal Investigator: Dennis Fasbinder, DDS School of Dentistry, Univ of Michigan
  More Information

Responsible Party: 3M
ClinicalTrials.gov Identifier: NCT01464294     History of Changes
Other Study ID Numbers: 3M ESPE CR-10-019
First Submitted: October 27, 2011
First Posted: November 3, 2011
Last Update Posted: January 27, 2015
Last Verified: December 2013

Keywords provided by 3M:
CAD/CAM
crowns
onlays
composite block
milled restorations