Clinical Evaluation of Lava Digital Veneer System (DVS) Crowns

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Evaluation of Lava Digital Veneer System (DVS) Crowns

Conditions
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Decay

Intervention / Treatment
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* Device: DVS veneer
* Device: Conventional Veneer


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DVS veneer<br>veneer made by CAD/CAM method | Device: DVS veneer<br>* CAD/CAM milled porcelain veneer for Lava crown<br>* Other names: Lava digital veneer system;|
| Active Comparator: Conventional veneer<br>Veneer made by laboratory technician | Device: Conventional Veneer<br>* CAD/CAM milled Lava crown with lab fabricated veneer<br>* Other names: Lava Crown;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lava, clinical, Crowns, posterior teeth, CAD CAM crowns, digital veneer system