MedDataX Logo

Clinical Evaluation of Lava Digital Veneer System (DVS) Crowns

NCT ID: NCT01278862

Last Updated: 2024-12-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2014-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Decay

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

DVS veneer

veneer made by CAD/CAM method

Group Type EXPERIMENTAL

DVS veneer

Intervention Type DEVICE

CAD/CAM milled porcelain veneer for Lava crown

Conventional veneer

Veneer made by laboratory technician

Group Type ACTIVE_COMPARATOR

Conventional Veneer

Intervention Type DEVICE

CAD/CAM milled Lava crown with lab fabricated veneer

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DVS veneer

CAD/CAM milled porcelain veneer for Lava crown

Intervention Type DEVICE

Conventional Veneer

CAD/CAM milled Lava crown with lab fabricated veneer

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Lava digital veneer system Lava Crown

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

3M

INDUSTRY

Sponsor Role collaborator

Solventum US LLC

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dennis Fasbinder, DDS

Role: PRINCIPAL_INVESTIGATOR

Univ of Michigan School of Dentistry

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Michigan Dental School

Ann Arbor, Michigan, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

3M ESPE CR-10-004

Identifier Type: -

Identifier Source: org_study_id