Clinical Evaluation of Lava Digital Veneer System (DVS) Crowns

Solventum US LLC

Status: Terminated

Conditions: Decay

Treatments: Device: DVS veneer; Device: Conventional Veneer

Study type: Interventional

Funder types: Industry

Identifiers

NCT01278862

3M ESPE CR-10-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 77 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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77 participants in 2 patient groups

DVS veneer

Experimental group

Description:

veneer made by CAD/CAM method

Treatment:

Device: DVS veneer

Conventional veneer

Active Comparator group

Description:

Veneer made by laboratory technician

Treatment:

Device: Conventional Veneer