NCT01278862

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 19, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

December 26, 2018

Completed
Last Updated

December 2, 2024

Status Verified

November 1, 2024

Enrollment Period

3.3 years

First QC Date

January 14, 2011

Results QC Date

November 8, 2017

Last Update Submit

November 27, 2024

Conditions

Decay

Keywords

Crownsposterior teethCAD CAM crownsdigital veneer systemLavaclinical

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

DVS veneer

EXPERIMENTAL

veneer made by CAD/CAM method

Device: DVS veneer

Conventional veneer

ACTIVE COMPARATOR

Veneer made by laboratory technician

Device: Conventional Veneer

Interventions

DVS veneerDEVICE

CAD/CAM milled porcelain veneer for Lava crown

Also known as: Lava digital veneer system
DVS veneer
Conventional VeneerDEVICE

CAD/CAM milled Lava crown with lab fabricated veneer

Also known as: Lava Crown
Conventional veneer

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Dental School

Ann Arbor, Michigan, 48109-1274, United States

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Results Point of Contact

Title
Rolf Halvorson
Organization
3M HCBG Clinical Operations
rhhalvorson@mmm.com
651-733-3384

Study Officials

  • Dennis Fasbinder, DDS

    Univ of Michigan School of Dentistry

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2011

First Posted

January 19, 2011

Study Start

November 1, 2010

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

December 2, 2024

Results First Posted

December 26, 2018

Record last verified: 2024-11

Locations

US(1)