CariesNCT05070416

Lithium Disilicate Crowns Study

A study testing Lithium disilicate crowns in people with Caries and Dental Trauma, run by Ivoclar Vivadent AG at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Caries, Dental Trauma
What is being tested?: Lithium disilicate crowns
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 1 siteUnited States
Study dates: 4 Oct 2021to 1 Mar 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan School of Dentistry
Ann Arbor, Michigan, 48109-1078

Other trials in United States

About this study

Official title: Clinical Evaluation of Lithium Disilicate CAD/CAM Crowns

Conditions: Caries, Dental Trauma
Being tested: Lithium disilicate crowns

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lithium disilicate crownsDevice
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).

Study groups in NCT05070416
Study group	Role	What they receive
Crowns self-adhesively cemented	Experimental	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). Receives: Device: Lithium disilicate crowns
Crowns adhesively luted	Experimental	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). Receives: Device: Lithium disilicate crowns

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Crowns With Short-term Post-operative Sensitivity
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"
Measured: 4 weeks

Secondary outcomes (1)

Quality Criteria (Modified FDI Criteria)
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)
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Oct 20211 Mar 2023

First posted7 Oct 2021
Study start4 Oct 2021
Primary completion1 Mar 2023
Study completion1 Mar 2023

Why it stopped: Material did not perform accordingly in other clinical trials.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CariesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05070416
Sponsor's protocol ID: LL3986001
Other IDs: HUM00191892
Status last verified: Sep 2025
First submitted: 27 Sep 2021
Last updated: 23 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Oral Health Intervention in Adult Primary Care
Dental Caries, Dry Mouth
Not yet recruitingObservational study
Artificial Intelligence Versus Clinical Examination in White Spot Lesions Detection, Identification, And Scoring
White Spot Lesion of Tooth
Not yet recruiting
The Effect of Bitewing Radiography on Outcomes and Costs of Treating Caries in Permanent Teeth
Dental Caries, Teeth Loss
Not yet recruiting
This Feasibility Study Will Evaluate the Study Protocols for Treatment and Follow-up Controls of Primary Molars With Caries in Children Treated With Stainless Steel Crowns or Conventional Fillings. Treatment Success and Potential Failures Will be Followed at 3, 6 and 12 Months Post Treatment.
Dental Caries, Early Childhood Caries (ECC)
Recruiting
A Study to Evaluate the Cariostatic Efficacy of Nano Silver Fluoride (NSF) vs. Silver Diamine Fluoride (SDF) in Children
Dental Caries

All Caries trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of Lithium Disilicate CAD/CAM Crowns
ClinicalTrials.gov ID: NCT05070416
Acronym / sponsor ID: LL3986001
Conditions: Caries, Dental Trauma
Study type: Interventional
Recruitment status: TerminatedReason stopped: Material did not perform accordingly in other clinical trials.
Enrolment: 8 participants (actual)
Lead sponsor: Ivoclar Vivadent AGIndustry (pharma, biotech, devices)
Collaborators: University of Michigan
Study start: 4 Oct 2021 (actual)
Primary completion: 1 Mar 2023 (actual)
Study completion: 1 Mar 2023 (actual)
First posted: 7 Oct 2021 (actual)
Results: Posted 14 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Crowns self-adhesively cemented	Experimental	Device: Lithium disilicate crownsGroup 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).
Crowns adhesively luted	Experimental	Device: Lithium disilicate crownsGroup 2 receives crowns with an occlusal thickness of 1.2 mm delivered with a dual-curing resin cement (Variolink Esthetic (DC),Ivoclar Vivadent AG).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lithium disilicate crownsThe 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).	Device	Crowns adhesively luted, Crowns self-adhesively cemented

Primary outcome

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"

1 secondary outcome

Quality Criteria (Modified FDI Criteria)
Time frame: 4 weeks

Results and safety

Results posted to the registry on 14 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Crowns self-adhesively cemented	3	3
Crowns adhesively luted	5	5

Primary outcome: Number of Crowns With Short-term Post-operative Sensitivity

Time frame: 4 weeks. Number. Unit: Crowns

Measure	Crowns self-adhesively cemented n = 3	Crowns adhesively luted n = 5
Value	0	0

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 4 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Crowns self-adhesively cemented	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Crowns adhesively luted	0 of 5 (0%)	0 of 5 (0%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Caries

Recruiting
Oral Health Intervention in Adult Primary Care
Dental Caries, Dry Mouth
Not yet recruitingObservational study
Artificial Intelligence Versus Clinical Examination in White Spot Lesions Detection, Identification, And Scoring
White Spot Lesion of Tooth
Not yet recruiting
The Effect of Bitewing Radiography on Outcomes and Costs of Treating Caries in Permanent Teeth
Dental Caries, Teeth Loss
Not yet recruiting
This Feasibility Study Will Evaluate the Study Protocols for Treatment and Follow-up Controls of Primary Molars With Caries in Children Treated With Stainless Steel Crowns or Conventional Fillings. Treatment Success and Potential Failures Will be Followed at 3, 6 and 12 Months Post Treatment.
Dental Caries, Early Childhood Caries (ECC)
Recruiting
A Study to Evaluate the Cariostatic Efficacy of Nano Silver Fluoride (NSF) vs. Silver Diamine Fluoride (SDF) in Children
Dental Caries

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dennis J. Fasbinder, DDS principal investigator

University of Michigan School of Dentistry, Department of Cariology, Restorative Sciences & Endodontics

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Lithium disilicate crowns in people with Caries and Dental Trauma, run by Ivoclar Vivadent AG at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 23 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Crowns With Short-term Post-operative Sensitivity (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05070416.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2025.