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product no longer on market
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| Name | Class |
|---|---|
| 3M | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DVS veneer | Experimental | veneer made by CAD/CAM method |
|
| Conventional veneer | Active Comparator | Veneer made by laboratory technician |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DVS veneer | Device | CAD/CAM milled porcelain veneer for Lava crown |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dennis Fasbinder, DDS | Univ of Michigan School of Dentistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Dental School | Ann Arbor | Michigan | 48109-1274 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | DVS Veneer | veneer made by CAD/CAM method DVS veneer: CAD/CAM milled porcelain veneer for Lava crown |
| FG001 | Conventional Veneer | Veneer made by laboratory technician DVS veneer: CAD/CAM milled porcelain veneer for Lava crown |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
77 patients enrolled in study- Each patient received a maximum of two crowns. Consequently, the total # of participants is less than the sum of participants in each group. If more than one crown placed, crowns may have been distributed as one from each group or two of the same group.
| ID | Title | Description |
|---|---|---|
| BG000 | DVS Veneer | veneer made by CAD/CAM method DVS veneer: CAD/CAM milled porcelain veneer for Lava crown |
| BG001 | Conventional Veneer | Veneer made by laboratory technician DVS veneer: CAD/CAM milled porcelain veneer for Lava crown |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Some patients received more than one crown. Such patients may have received multiple (maximum 2) of the same type of crown or a crown from both arms. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Number of crowns evaluated within each group after 1 year in vivo | Posted | Count of Units | Crowns | 1 year | Crowns | Crowns |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DVS Veneer | veneer made by CAD/CAM method DVS veneer: CAD/CAM milled porcelain veneer for Lava crown |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rolf Halvorson | 3M HCBG Clinical Operations | 651-733-3384 | rhhalvorson@mmm.com |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| Conventional Veneer | Device | CAD/CAM milled Lava crown with lab fabricated veneer |
|
|
| BG002 | Total | Total of all reporting groups |
| Crowns |
|
| Count of Units |
| Crowns |
| Crowns |
|
|
| Sex: Female, Male | Some patients received more than one crown. Such patients may have received multiple (maximum 2) of the same type of crown or a crown from both arms. | Count of Units | Crowns | Crowns |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
|
| DVS Veneer |
veneer made by CAD/CAM method DVS veneer: CAD/CAM milled porcelain veneer for Lava crown |
| OG001 | Conventional Veneer | Veneer made by laboratory technician DVS veneer: CAD/CAM milled porcelain veneer for Lava crown |
|
|
|
| Primary | 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. | Number of crowns evaluated within each group after 1 year in vivo | Posted | Number | Crowns | 1 year | Crowns | Crowns |
|
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| EG001 | Conventional Veneer | Veneer made by laboratory technician DVS veneer: CAD/CAM milled porcelain veneer for Lava crown | 0 | 43 | 0 | 43 |
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|
|
|
|
|
|
|
| Plaque Index=0 |
|
| Plaque Index=1 |
|
| 0.5240 |
| Superiority |