Clinical Evaluation of Lava Digital Veneer System (DVS) Crowns

Solventum US LLC77 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Decay

Interventions

DVS veneerDEVICE

CAD/CAM milled porcelain veneer for Lava crown

Conventional VeneerDEVICE

CAD/CAM milled Lava crown with lab fabricated veneer

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Michigan Dental School

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Clinical Performance of Crowns Via Modified United States Public Health Service (USPHS) Criteria

Performance reported as the % of teeth with perfect (alpha/A) scores. USPHS criteria: Color Match ( A=Ideal, B=perceptible mismatch but acceptable, C=obvious mismatch and unacceptable); Margin Adaptation (A=no visible crevice, B=crevice along \<50% margin\>1mm depth, C=crevice along\>50% margin \>1mm depth); Margin discoloration (A=none, B=Surface stain non penetrating, C=Penetrating; Surface Finish (A=smooth, B=moderately uniformly rough, C=significant pitts/voids; Crown Fracture (A=none, B=small but repairable, C= coping exposed/complete delamination; Proximal Contact (A=firm resistance to floss/ideal contact, B=light resistance/variable breadth, C=open; Sensitivity (A=none, B= slight but not uncomfortable, C=severe; Caries (A=no evidence, B= evident but repairable, C=evident/not repairable.

Time frame: 1 year

Gingival/Periodontal Health Based on Loe & Stillness Index, 1963.

Performance reported as the # of crowns exhibiting 0, 1, 2 and 3 index score. Gingival Index (0=normal, 1=mild inflammation, 2=moderate inflammation, 3=severe inflammation. Plaque Index (0= none, 1= observed only via probe at on tooth surface at gingival crest, 2=moderate accumulation along gingival margin and adjacent tooth, 3= abundant plaque along gingival margin and adjacent tooth.

Time frame: 1 year

Data from ClinicalTrials.gov

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