Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

January 14, 2011
July 10, 2013
November 2010
March 2014   (final data collection date for primary outcome measure)
Clinical performance of crowns [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Subjective evaluation of study crowns using USPHS criteria
Same as current
Complete list of historical versions of study NCT01278862 on ClinicalTrials.gov Archive Site
Luting cement [ Time Frame: 3 years ] [ Designated as safety issue: No ]
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acceptable Performance of Crowns in Clinical Service
  • Post-operative Sensitivity of Study Crowns
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
75
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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01278862
3M ESPE CR-10-004
No
3M
3M
Not Provided
Principal Investigator: Dennis Fasbinder, DDS Univ of Michigan School of Dentistry
3M
July 2013

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