Clinical Evaluation of Lava Digital Veneer System (DVS) Crowns

Not Applicable

Terminated

• Conditions: Decay
• Interventions: Device: DVS veneer; Device: Conventional Veneer

• Registration Number: NCT01278862
• Lead Sponsor: Solventum US LLC

Brief Summary

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

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 Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-01-14
• Study First Submitted QC: 2011-01-18
• Study First Posted: 2011-01-19
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Results First Submitted: 2017-11-08
• Results First Submitted QC: 2018-12-03
• Results First Posted: 2018-12-26
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 77

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DVS veneer	DVS veneer	veneer made by CAD/CAM method
Conventional veneer	Conventional Veneer	Veneer made by laboratory technician

Primary Outcome Measures

Name	Time	Method
Clinical Performance of Crowns Via Modified United States Public Health Service (USPHS) Criteria	1 year	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.
Gingival/Periodontal Health Based on Loe & Stillness Index, 1963.	1 year	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.

Trial Locations

Locations (1)

University of Michigan Dental School; 🇺🇸 Ann Arbor, Michigan, United States