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: December 30, 2013
Last verified: December 2013
  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

Resource links provided by NLM:


Further study details as provided by 3M:

Primary Outcome Measures:
  • clinical performance [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Subjective evaluation of restorations using USPHS criteria


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 120
Study Start Date: October 2011
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: December 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: 3M
ClinicalTrials.gov Identifier: NCT01464294     History of Changes
Other Study ID Numbers: 3M ESPE CR-10-019
Study First Received: October 27, 2011
Last Updated: December 30, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014