Trial Outcomes & Findings for Clinical Evaluation of Lava Digital Veneer System (DVS) Crowns (NCT NCT01278862)

Last Updated: 2024-12-02

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

77 participants

Primary outcome timeframe

1 year

Results posted on

2024-12-02

Participant Flow

Unit of analysis: Crowns

Participant milestones

Participant milestones
Measure	DVS Veneer veneer made by CAD/CAM method DVS veneer: CAD/CAM milled porcelain veneer for Lava crown	Conventional Veneer Veneer made by laboratory technician DVS veneer: CAD/CAM milled porcelain veneer for Lava crown
Overall Study STARTED	45 50	43 50
Overall Study COMPLETED	44 49	42 49
Overall Study NOT COMPLETED	1 1	1 1

Reasons for withdrawal

Reasons for withdrawal
Measure	DVS Veneer veneer made by CAD/CAM method DVS veneer: CAD/CAM milled porcelain veneer for Lava crown	Conventional Veneer Veneer made by laboratory technician DVS veneer: CAD/CAM milled porcelain veneer for Lava crown
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

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.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DVS Veneer n=50 Crowns veneer made by CAD/CAM method DVS veneer: CAD/CAM milled porcelain veneer for Lava crown	Conventional Veneer n=50 Crowns Veneer made by laboratory technician DVS veneer: CAD/CAM milled porcelain veneer for Lava crown	Total n=100 Crowns Total of all reporting groups
Age, Categorical <=18 years	0 Crowns n=50 Crowns • 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.	0 Crowns n=50 Crowns • 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.	0 Crowns n=100 Crowns • 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.
Age, Categorical Between 18 and 65 years	44 Crowns n=50 Crowns • 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.	46 Crowns n=50 Crowns • 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.	90 Crowns n=100 Crowns • 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.
Age, Categorical >=65 years	6 Crowns n=50 Crowns • 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.	4 Crowns n=50 Crowns • 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.	10 Crowns n=100 Crowns • 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.
Sex: Female, Male Female	38 Crowns n=50 Crowns • 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.	33 Crowns n=50 Crowns • 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.	71 Crowns n=100 Crowns • 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.
Sex: Female, Male Male	12 Crowns n=50 Crowns • 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.	17 Crowns n=50 Crowns • 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.	29 Crowns n=100 Crowns • 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.
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 1 year

Population: Number of crowns evaluated within each group after 1 year in vivo

Outcome measures

Outcome measures
Measure	DVS Veneer n=49 Crowns veneer made by CAD/CAM method DVS veneer: CAD/CAM milled porcelain veneer for Lava crown	Conventional Veneer n=49 Crowns Veneer made by laboratory technician DVS veneer: CAD/CAM milled porcelain veneer for Lava crown
Clinical Performance of Crowns Via Modified United States Public Health Service (USPHS) Criteria Color Match	49 Crowns	46 Crowns
Clinical Performance of Crowns Via Modified United States Public Health Service (USPHS) Criteria Proximal Contace - Distal	42 Crowns	41 Crowns
Clinical Performance of Crowns Via Modified United States Public Health Service (USPHS) Criteria Margin Adaptation	49 Crowns	49 Crowns
Clinical Performance of Crowns Via Modified United States Public Health Service (USPHS) Criteria Margin Discoloration	49 Crowns	48 Crowns
Clinical Performance of Crowns Via Modified United States Public Health Service (USPHS) Criteria Surface Finish	49 Crowns	49 Crowns
Clinical Performance of Crowns Via Modified United States Public Health Service (USPHS) Criteria Caries	49 Crowns	49 Crowns
Clinical Performance of Crowns Via Modified United States Public Health Service (USPHS) Criteria Crown Fracture	48 Crowns	48 Crowns
Clinical Performance of Crowns Via Modified United States Public Health Service (USPHS) Criteria Sensitivity	49 Crowns	49 Crowns
Clinical Performance of Crowns Via Modified United States Public Health Service (USPHS) Criteria Proximal Contact - Mesial	48 Crowns	47 Crowns

PRIMARY outcome

Timeframe: 1 year

Population: Number of crowns evaluated within each group after 1 year in vivo

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.

Outcome measures

Outcome measures
Measure	DVS Veneer n=49 Crowns veneer made by CAD/CAM method DVS veneer: CAD/CAM milled porcelain veneer for Lava crown	Conventional Veneer n=49 Crowns Veneer made by laboratory technician DVS veneer: CAD/CAM milled porcelain veneer for Lava crown
Gingival/Periodontal Health Based on Loe & Stillness Index, 1963. Gingival Index=0	49 Crowns	48 Crowns
Gingival/Periodontal Health Based on Loe & Stillness Index, 1963. Gingival Index=1	0 Crowns	1 Crowns
Gingival/Periodontal Health Based on Loe & Stillness Index, 1963. Plaque Index=0	42 Crowns	45 Crowns
Gingival/Periodontal Health Based on Loe & Stillness Index, 1963. Plaque Index=1	7 Crowns	4 Crowns

Adverse Events

DVS Veneer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Conventional Veneer

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rolf Halvorson

3M HCBG Clinical Operations

Phone: 651-733-3384

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place