Decay
Conditions
Keywords
Crowns, posterior teeth, CAD CAM crowns, digital veneer system, Lava, clinical
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.
Interventions
DEVICEDVS veneer
CAD/CAM milled porcelain veneer for Lava crown
DEVICEConventional Veneer
CAD/CAM milled Lava crown with lab fabricated veneer
Sponsors
3M
Solventum US LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DVS Veneer veneer made by CAD/CAM method
DVS veneer: CAD/CAM milled porcelain veneer for Lava crown | 45 |
| DVS Veneer veneer made by CAD/CAM method
DVS veneer: CAD/CAM milled porcelain veneer for Lava crown | 50 |
| Conventional Veneer Veneer made by laboratory technician
DVS veneer: CAD/CAM milled porcelain veneer for Lava crown | 43 |
| Conventional Veneer Veneer made by laboratory technician
DVS veneer: CAD/CAM milled porcelain veneer for Lava crown | 50 |
| Total | 188 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | DVS Veneer | Conventional Veneer | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Crowns | 0 Crowns | 0 Crowns |
| Age, Categorical >=65 years | 6 Crowns | 4 Crowns | 10 Crowns |
| Age, Categorical Between 18 and 65 years | 44 Crowns | 46 Crowns | 90 Crowns |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 38 Crowns | 33 Crowns | 71 Crowns |
| Sex: Female, Male Male | 12 Crowns | 17 Crowns | 29 Crowns |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 45 | 0 / 43 |
| serious Total, serious adverse events | 0 / 45 | 0 / 43 |
Outcome results
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.
Time frame: 1 year
Population: Number of crowns evaluated within each group after 1 year in vivo
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| DVS Veneer | Clinical Performance of Crowns Via Modified United States Public Health Service (USPHS) Criteria | Margin Adaptation | 49 Crowns |
| DVS Veneer | Clinical Performance of Crowns Via Modified United States Public Health Service (USPHS) Criteria | Crown Fracture | 48 Crowns |
| DVS Veneer | Clinical Performance of Crowns Via Modified United States Public Health Service (USPHS) Criteria | Surface Finish | 49 Crowns |
| DVS Veneer | Clinical Performance of Crowns Via Modified United States Public Health Service (USPHS) Criteria | Sensitivity | 49 Crowns |
| DVS Veneer | Clinical Performance of Crowns Via Modified United States Public Health Service (USPHS) Criteria | Margin Discoloration | 49 Crowns |
| DVS Veneer | Clinical Performance of Crowns Via Modified United States Public Health Service (USPHS) Criteria | Proximal Contact - Mesial | 48 Crowns |
| DVS Veneer | Clinical Performance of Crowns Via Modified United States Public Health Service (USPHS) Criteria | Caries | 49 Crowns |
| DVS Veneer | Clinical Performance of Crowns Via Modified United States Public Health Service (USPHS) Criteria | Proximal Contace - Distal | 42 Crowns |
| DVS Veneer | Clinical Performance of Crowns Via Modified United States Public Health Service (USPHS) Criteria | Color Match | 49 Crowns |
| Conventional Veneer | Clinical Performance of Crowns Via Modified United States Public Health Service (USPHS) Criteria | Proximal Contace - Distal | 41 Crowns |
| Conventional Veneer | Clinical Performance of Crowns Via Modified United States Public Health Service (USPHS) Criteria | Color Match | 46 Crowns |
| Conventional Veneer | Clinical Performance of Crowns Via Modified United States Public Health Service (USPHS) Criteria | Margin Adaptation | 49 Crowns |
| Conventional Veneer | Clinical Performance of Crowns Via Modified United States Public Health Service (USPHS) Criteria | Margin Discoloration | 48 Crowns |
| Conventional Veneer | Clinical Performance of Crowns Via Modified United States Public Health Service (USPHS) Criteria | Surface Finish | 49 Crowns |
| Conventional Veneer | Clinical Performance of Crowns Via Modified United States Public Health Service (USPHS) Criteria | Caries | 49 Crowns |
| Conventional Veneer | Clinical Performance of Crowns Via Modified United States Public Health Service (USPHS) Criteria | Crown Fracture | 48 Crowns |
| Conventional Veneer | Clinical Performance of Crowns Via Modified United States Public Health Service (USPHS) Criteria | Sensitivity | 49 Crowns |
| Conventional Veneer | Clinical Performance of Crowns Via Modified United States Public Health Service (USPHS) Criteria | Proximal Contact - Mesial | 47 Crowns |
Comparison: null hypothesis no difference in color matchp-value: 0.2423Fisher Exact
Comparison: null hypothesis no difference in margin discolorationp-value: >0.999Fisher Exact
Comparison: null hypothesis no difference in crown fracturep-value: >0.999Fisher Exact
Comparison: Null hypothesis no difference in Proximal Contact - Mesialp-value: >0.999Fisher Exact
Comparison: Null hypothesis no difference in proximal contact - distalp-value: >0.999Fisher Exact
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.
Time frame: 1 year
Population: Number of crowns evaluated within each group after 1 year in vivo
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DVS Veneer | Gingival/Periodontal Health Based on Loe & Stillness Index, 1963. | Gingival Index=0 | 49 Crowns |
| DVS Veneer | Gingival/Periodontal Health Based on Loe & Stillness Index, 1963. | Gingival Index=1 | 0 Crowns |
| DVS Veneer | Gingival/Periodontal Health Based on Loe & Stillness Index, 1963. | Plaque Index=0 | 42 Crowns |
| DVS Veneer | Gingival/Periodontal Health Based on Loe & Stillness Index, 1963. | Plaque Index=1 | 7 Crowns |
| Conventional Veneer | Gingival/Periodontal Health Based on Loe & Stillness Index, 1963. | Plaque Index=1 | 4 Crowns |
| Conventional Veneer | Gingival/Periodontal Health Based on Loe & Stillness Index, 1963. | Gingival Index=0 | 48 Crowns |
| Conventional Veneer | Gingival/Periodontal Health Based on Loe & Stillness Index, 1963. | Plaque Index=0 | 45 Crowns |
| Conventional Veneer | Gingival/Periodontal Health Based on Loe & Stillness Index, 1963. | Gingival Index=1 | 1 Crowns |
Comparison: null hypothesis no difference in gingival indexp-value: >0.999Fisher Exact
Comparison: null hypothesis no difference in plaque indexp-value: 0.524Fisher Exact