CariesNCT04933123

Clinical Evaluation of a Dental Glass Ceramic

A study testing indirect restorative treatment with a glass ceramic in people with Caries and Dental Trauma, run by Ivoclar Vivadent AG at 1 site in Liechtenstein.

Terminated

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

Official record

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Trial summary

A clinical trial with an experimental glass ceramic (shades A1, A2 and A3) to ensure the safety and efficacy of the product. It is a study with single-arm in which inlays and onlays for molars and premolars are adhesively luted. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Caries, Dental Trauma
What is being tested?: indirect restorative treatment with a glass ceramic
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 1 siteLiechtenstein
Study dates: 14 Sep 2021to 15 Nov 2021
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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age: 18-65 years
Indication for indirect restorations (inlay, onlay) in molar or premolar - replacement of insufficient fillings (e.g. due to caries at margins, filling fracture, fracture of the tooth, poor quality of the surface, leaking margin, etc.) or extensive primary caries
The occlusal area of the restoration must cover at least 1/3 of the occlusal area of the tooth.
Participant wishes a restoration within the scope of the study (signed informed consent after detailed explanation and study of the patient information)
Pre-operative discomfort of the tooth to be restored should not exceed 3 on the visual analogue scale (VAS) (0=no pain, 10=maximum conceivable pain) due to temperature stimulus or bite sensitivity
Max. 2 restorations per participant in different quadrants.

Show all 9Show fewer

Healthy periodontium, no active periodontitis
Contact with adjacent teeth (at least at one side) and opposing teeth present with at least one contact point.
Sufficient language skills

Who cannot join

Sufficient isolation not possible, dry working field cannot be guaranteed
Participants with a proven allergy to one of the ingredients of the materials used
Participants with proven allergy to local anaesthetics
High caries activity/ poor oral hygiene
Participants with severe systemic diseases
Pregnancy
Symptoms of SARS (severe acute respiratory syndrome)-CoV2 (Corona Virus 2) infection

Trial locations and contacts

1 site in 1 country.

Liechtenstein1 site

Ivoclar Vivadent
Schaan, 9494

About this study

Official title: Clinical Evaluation of a New Dental Glass Ceramic in the Indirect Restorative Therapy

Conditions: Caries, Dental Trauma
Being tested: indirect restorative treatment with a glass ceramic

What participants receive

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

indirect restorative treatment with a glass ceramicDevice
Inlays and onlays of glass ceramic for molars and premolars are adhesively luted.

Study groups in NCT04933123
Study group	Role	What they receive
Inlay/Onlay	Experimental	shades A1, A2 and A3 Receives: Device: indirect restorative treatment with a glass ceramic

What is being measured

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

Survival Rate of Inlays and Onlays
Inlay and onlay restorations were examined by a dentist
Measured: Baseline (7-10 days after insertion of restoration)

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, fracture of material, retension, occlusal contour and wear, and colour match of restorations)
Measured: Baseline (7-10 days after insertion of restoration)

Timeline

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

14 Sep 202115 Nov 2021

First posted21 Jun 2021
Study start14 Sep 2021
Primary completion15 Nov 2021
Study completion15 Nov 2021

Why it stopped: insufficient clinical performance which might have led to AE

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04933123
Sponsor's protocol ID: LL3965040
Status last verified: Apr 2025
First submitted: 14 Jun 2021
Last updated: 20 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
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

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All Caries trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of a New Dental Glass Ceramic in the Indirect Restorative Therapy
ClinicalTrials.gov ID: NCT04933123
Acronym / sponsor ID: LL3965040
Conditions: Caries, Dental Trauma
Study type: Interventional
Recruitment status: TerminatedReason stopped: insufficient clinical performance which might have led to AE
Enrolment: 13 participants (actual)
Lead sponsor: Ivoclar Vivadent AGIndustry (pharma, biotech, devices)
Study start: 14 Sep 2021 (actual)
Primary completion: 15 Nov 2021 (actual)
Study completion: 15 Nov 2021 (actual)
First posted: 21 Jun 2021 (actual)
Results: Posted 2 Apr 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Inlay/Onlay	Experimental	Device: indirect restorative treatment with a glass ceramicshades A1, A2 and A3

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Age: 18-65 years
Indication for indirect restorations (inlay, onlay) in molar or premolar - replacement of insufficient fillings (e.g. due to caries at margins, filling fracture, fracture of the tooth, poor quality of the surface, leaking margin, etc.) or extensive primary caries
The occlusal area of the restoration must cover at least 1/3 of the occlusal area of the tooth.
Participant wishes a restoration within the scope of the study (signed informed consent after detailed explanation and study of the patient information)
Pre-operative discomfort of the tooth to be restored should not exceed 3 on the visual analogue scale (VAS) (0=no pain, 10=maximum conceivable pain) due to temperature stimulus or bite sensitivity

Key exclusion criteria (7 listed)

Sufficient isolation not possible, dry working field cannot be guaranteed
Participants with a proven allergy to one of the ingredients of the materials used
Participants with proven allergy to local anaesthetics
High caries activity/ poor oral hygiene
Participants with severe systemic diseases

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
indirect restorative treatment with a glass ceramicInlays and onlays of glass ceramic for molars and premolars are adhesively luted.	Device	Inlay/Onlay

Primary outcome

Survival Rate of Inlays and Onlays
Time frame: Baseline (7-10 days after insertion of restoration)
Inlay and onlay restorations were examined by a dentist

1 secondary outcome

Quality Criteria (Modified FDI Criteria)
Time frame: Baseline (7-10 days after insertion of restoration)

Results and safety

Results posted to the registry on 2 Apr 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
Inlay/Onlay	13	13

Primary outcome: Survival Rate of Inlays and Onlays

Time frame: Baseline (7-10 days after insertion of restoration). Number. Unit: Inlays/Onlays

Measure	Inlay/Onlay n = 13
Value	13

1 secondary outcome is reported in the full results.

Adverse events

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

Group	Serious adverse events	Other adverse events	Deaths
Inlay/Onlay	0 of 13 (0%)	0 of 13 (0%)	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Caries

Active, not recruiting
Trial With Two New Tooth-colored Restorative Materials in Class I/II Cavities
Caries, Defective Restorations
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruitingObservational study
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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A study testing indirect restorative treatment with a glass ceramic in people with Caries and Dental Trauma, run by Ivoclar Vivadent AG at 1 site in Liechtenstein.

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 9 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 20 Apr 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 Liechtenstein. 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 2 Apr 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?

Survival Rate of Inlays and Onlays (time frame: Baseline (7-10 days after insertion of restoration)). 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 NCT04933123.

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 20 Apr 2025.