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: July 10, 2013
Last verified: July 2013
  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:


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
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: 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: July 10, 2013
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 July 26, 2014