Clinical Evaluation of Lava Digital Veneer System (DVS) Crowns

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01278862
Recruitment Status : Terminated (product no longer on market)
First Posted : January 19, 2011
Last Update Posted : January 26, 2015
Information provided by (Responsible Party):

January 14, 2011
January 19, 2011
January 26, 2015
November 2010
March 2014   (Final data collection date for primary outcome measure)
Clinical performance of crowns [ Time Frame: 3 years ]
Subjective evaluation of study crowns using USPHS criteria
Same as current
Complete list of historical versions of study NCT01278862 on Archive Site
Luting cement [ Time Frame: 3 years ]
Post-operative sensitivity
Same as current
Not Provided
Not Provided
Clinical Evaluation of Lava Digital Veneer System (DVS) Crowns
Clinical Evaluation of Lava Digital Veneer System (DVS) Crowns
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.
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.
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Device: DVS veneer
CAD/CAM milled porcelain veneer for Lava crown
Other Names:
  • Lava digital veneer system
  • Laboratory fabricated porcelain veneer
  • Experimental: DVS veneer
    veneer made by CAD/CAM method
    Intervention: Device: DVS veneer
  • Active Comparator: Conventional veneer
    Veneer made by laboratory technician
    Intervention: Device: DVS veneer
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
March 2014
March 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
19 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
3M ESPE CR-10-004
Not Provided
Not Provided
Not Provided
Principal Investigator: Dennis Fasbinder, DDS Univ of Michigan School of Dentistry
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP