This trial is active, not recruiting.

Conditions acceptable performance of crowns in clinical service, post-operative sensitivity of study crowns
Treatment dvs veneer
Sponsor 3M
Start date November 2010
End date March 2014
Trial size 75 participants
Trial identifier NCT01278862, 3M ESPE CR-10-004


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
veneer made by CAD/CAM method
dvs veneer Lava digital veneer system
CAD/CAM milled porcelain veneer for Lava crown
(Active Comparator)
Veneer made by laboratory technician
dvs veneer Lava digital veneer system
CAD/CAM milled porcelain veneer for Lava crown

Primary Outcomes

Clinical performance of crowns
time frame: 3 years

Secondary Outcomes

Luting cement
time frame: 3 years

Eligibility Criteria

Male or female participants at least 19 years old.

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

Additional Information

Official title Clinical Evaluation of Lava Digital Veneer System (DVS) Crowns
Principal investigator Dennis Fasbinder, DDS
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2013.
Information provided to ClinicalTrials.gov by 3M.