Lithium Disilicate Crowns Study

September 26, 2025 updated by: Ivoclar Vivadent AG

Clinical Evaluation of Lithium Disilicate CAD/CAM Crowns

CAD-CAM crowns made of experimental lithium disilicate (shades A1, A2 and A3) are placed in patients by using either a dual-curing adhesive or a self-adhesive luting material in combination with total etch/universal bonding agent.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Dennis J. Fasbinder, DDS
  • Phone Number: (734) 647-4450
  • Email: djfas@umich.edu

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-1078
        • University of Michigan School of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients will be at least 18 years of age, of either gender, and of any ethnic background.
  • Each patient should have at least one carious lesion or defective restoration to be restored on a maxillary or mandibular premolar or molar tooth.
  • Each lesion or defective restoration should exhibit sufficient size or loss of tooth structure requiring a full crown restoration.
  • The tooth should have at least one opposing tooth in occlusion and one adjacent tooth with an intact proximal contact.
  • All teeth will test vital and be asymptomatic at the beginning of treatment. No more than two restorations will be placed per patient.

Exclusion Criteria:

  • Devital or sensitive teeth
  • Teeth with prior endodontic treatment of any kind
  • Teeth with a history of direct or indirect pulp capping procedures
  • Patients with significant untreated dental disease to include periodontitis and/or rampant caries
  • Women who self-report that they are possibly pregnant, pregnant, or lactating, as elective dental treatment is not indicated at these times
  • Patients with a self-reported past history of allergies to the materials to be used in the study including composite resin cements or ceramic restorative materials
  • Patients unable to return for the recall appointments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Crowns self-adhesively cemented
Group 1 receives crowns with an occlusal thickness of 1.5 mm and luted with a self-adhesive, self-curing resin cement (SpeedCem Plus, Ivoclar Vivadent AG).
Device: Lithium disilicate crowns
The study population is separated in two groups. The teeth will be etched in total etch mode with 37% phosphoric acid (Total Etch, Ivoclar Vivadent AG). After the application of Adhese Universal-adhesive (Ivoclar Vivadent AG), MultiCore Flow (Ivoclar Vivadent AG) will be applied. The crowns will be polished, then etched with IPS Ceramic Etching Gel (Ivoclar Vivadent AG) and conditioned with Monobond Plus (Ivoclar Vivadent AG). The crowns will be luted as described for group 1 or 2. A final intraoral polishing step will be done with OptraGloss (Ivoclar Vivadent AG). All required light-curing steps are conducted with Bluephase G4 (Ivoclar Vivadent AG).
Experimental: Crowns adhesively luted
Group 2 receives crowns with an occlusal thickness of 1.2 mm delivered with a dual-curing resin cement (Variolink Esthetic (DC),Ivoclar Vivadent AG).
Device: Lithium disilicate crowns
The study population is separated in two groups. The teeth will be etched in total etch mode with 37% phosphoric acid (Total Etch, Ivoclar Vivadent AG). After the application of Adhese Universal-adhesive (Ivoclar Vivadent AG), MultiCore Flow (Ivoclar Vivadent AG) will be applied. The crowns will be polished, then etched with IPS Ceramic Etching Gel (Ivoclar Vivadent AG) and conditioned with Monobond Plus (Ivoclar Vivadent AG). The crowns will be luted as described for group 1 or 2. A final intraoral polishing step will be done with OptraGloss (Ivoclar Vivadent AG). All required light-curing steps are conducted with Bluephase G4 (Ivoclar Vivadent AG).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Crowns With Short-term Post-operative Sensitivity
Time Frame: 4 weeks
assessed by patient's weekly feedback for 4 weeks after the treatment rating sensitivity from 1 "no sensitivity" to 4 "severe discomfort noted routinely with cold or pressure stimulation"
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality Criteria (Modified FDI Criteria)
Time Frame: 4 weeks
assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" (e.g. surface lustre, Staining, and colour match of restorations)
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ivoclar Vivadent AG

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Michigan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dennis J. Fasbinder, DDS, University of Michigan School of Dentistry, Department of Cariology, Restorative Sciences & Endodontics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 4, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 7, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LL3986001
  • HUM00191892 (Registry Identifier: IRBMED (Medical School Institutional Review Board))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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