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Clinical Evaluation of Chairside CAD/CAM Nano-ceramic Restorations

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
3M
ClinicalTrials.gov Identifier:
NCT01464294
First received: October 27, 2011
Last updated: January 28, 2013
Last verified: January 2013
History of Changes

October 27, 2011
January 28, 2013
October 2011
December 2015   (final data collection date for primary outcome measure)
clinical performance [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Subjective evaluation of restorations using USPHS criteria
Same as current
Complete list of historical versions of study NCT01464294 on ClinicalTrials.gov Archive Site
Luting cement [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Subjective evaluaton of performance of a nano-filled resin luting cement used to cement the study onlays
Same as current
Not Provided
Not Provided
 
Clinical Evaluation of Chairside CAD/CAM Nano-ceramic Restorations
Clinical Evaluation of Chairside CAD/CAM Nano-ceramic Restorations

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.
Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients attending and/or under clinical treatment at the University of Michigan Dental Clinics
Restoration of Posterior Teeth
  • Device: Milled ceramic restorations
    Restoration of back teeth with milled ceramic crowns or onlays
    Other Name: Empress CAD/CAM leucite porcelain (Ivoclar Vivadent)
  • Device: Milled nano-composite restorations
    Restoration of back teeth with milled crowns or onlays
    Other Name: Lava Ultimate CAD/CAM Restorative (3M ESPE)
  • nano-composite
    crowns and onlays
    Intervention: Device: Milled nano-composite restorations
  • ceramic
    crowns & onlays
    Intervention: Device: Milled ceramic restorations
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01464294
3M ESPE CR-10-019
No
3M
3M
Not Provided
Principal Investigator: Dennis Fasbinder, DDS School of Dentistry, Univ of Michigan
3M
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP