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Clinical Evaluation of Lava Digital Veneer System (DVS) Crowns

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ClinicalTrials.gov Identifier: NCT01278862
Recruitment Status : Terminated (product no longer on market)
First Posted : January 19, 2011
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):
3M

Brief Summary:
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 or disease Intervention/treatment Phase
Decay Device: DVS veneer Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Lava Digital Veneer System (DVS) Crowns
Study Start Date : November 2010
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Clinical performance of crowns [ Time Frame: 3 years ]
    Subjective evaluation of study crowns using USPHS criteria


Secondary Outcome Measures :
  1. Luting cement [ Time Frame: 3 years ]
    Post-operative sensitivity



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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: 3M
ClinicalTrials.gov Identifier: NCT01278862     History of Changes
Other Study ID Numbers: 3M ESPE CR-10-004
First Posted: January 19, 2011    Key Record Dates
Last Update Posted: January 26, 2015
Last Verified: July 2013

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