Text Size

Clinical Evaluation of Lava Digital Veneer System (DVS) Crowns

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
3M
ClinicalTrials.gov Identifier:
NCT01278862
First received: January 14, 2011
Last updated: June 12, 2012
Last verified: June 2012
History of Changes
  Purpose

Study aim is to compare Lava Computer Aided Design / Computer Aided Milling Computer Aided Machining (CAD/CAM)crowns that are veneered (covered) with porcelain that has been milled using CAD/CAM, with similar CAD/CAM Lava crowns that have been veneered with a hand fabricated porcelain covering.


Condition Intervention
Acceptable Performance of Crowns in Clinical Service
Post-operative Sensitivity of Study Crowns
 Device: DVS veneer

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Lava Digital Veneer System (DVS) Crowns

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by 3M:

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


Secondary Outcome Measures:
  • Luting cement [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Post-operative sensitivity


Estimated Enrollment: 75
Study Start Date: November 2010
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DVS veneer
veneer made by CAD/CAM method
 Device: DVS veneer
CAD/CAM milled porcelain veneer for Lava crown
Other Names:
  • Lava digital veneer system
  • Laboratory fabricated porcelain veneer
Active Comparator: Conventional veneer
Veneer made by laboratory technician
 Device: DVS veneer
CAD/CAM milled porcelain veneer for Lava crown
Other Names:
  • Lava digital veneer system
  • Laboratory fabricated porcelain veneer

Detailed Description:

Veneers will be randomly allocated to study crowns. Study crowns will be evaluated over three years. The test porcelain veneer is CAD/CAM milled as a veneer shell that is then fused to the CAD/CAM milled Lava crown to make the final crown to be cemented in the patient's mouth. This may be a more predictable technique in the fabrication of Lava crowns than current conventional methods.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Over 18 years of age.
  • Have at least one decayed back tooth in need of a crown
  • Study tooth to be an upper or lower premolar or molar tooth/ teeth
  • Study tooth to be vital and asymptomatic at start of study

Exclusion Criteria:

  • Teeth which are non vital, have had root canal treatment
  • Teeth which are pulp capped
  • Sensitive teeth
  • Significant untreated dental disease including periodontitis and rampant decay
  • Pregnant or lactating women
  • Patients with allergies to any of the materials to be used in the study
  • Unable to attend the recall appointments
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01278862

Locations
United States, Michigan
University of Michigan Dental School
Ann Arbor, Michigan, United States, 48109-1274
Sponsors and Collaborators
3M
Investigators
Principal Investigator: Dennis Fasbinder, DDS Univ of Michigan School of Dentistry
  More Information

No publications provided

Responsible Party: 3M
ClinicalTrials.gov Identifier: NCT01278862     History of Changes
Other Study ID Numbers: 3M ESPE CR-10-004
Study First Received: January 14, 2011
Last Updated: June 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by 3M:
Crowns
posterior teeth
CAD CAM crowns
 digital veneer system
Lava
clinical

ClinicalTrials.gov processed this record on May 19, 2013