Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

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
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 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 November 20, 2014