NCT01464294

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 3, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 2, 2024

Status Verified

November 1, 2024

Enrollment Period

3.2 years

First QC Date

October 27, 2011

Last Update Submit

November 27, 2024

Conditions

Restoration of Posterior Teeth

Keywords

CAD/CAMcrownsonlayscomposite blockmilled restorations

Outcome Measures

Primary Outcomes (1)

  • clinical performance

    Subjective evaluation of restorations using USPHS criteria

    3 years

Secondary Outcomes (1)

  • Luting cement

    3 years

Study Arms (2)

nano-composite

crowns and onlays

Device: Milled nano-composite restorations

ceramic

crowns \& onlays

Device: Milled ceramic restorations

Interventions

Milled ceramic restorationsDEVICE

Restoration of back teeth with milled ceramic crowns or onlays

Also known as: Empress CAD/CAM leucite porcelain (Ivoclar Vivadent)
ceramic
Milled nano-composite restorationsDEVICE

Restoration of back teeth with milled crowns or onlays

Also known as: Lava Ultimate CAD/CAM Restorative (3M ESPE)
nano-composite

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients attending and/or under clinical treatment at the University of Michigan Dental Clinics

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Dentistry, Unversity of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Study Officials

  • Dennis Fasbinder, DDS

    School of Dentistry, Univ of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2011

First Posted

November 3, 2011

Study Start

October 1, 2011

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

December 2, 2024

Record last verified: 2024-11

Locations

US(1)