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New Tooth-Colored material for Same-Day dental crowns put to the test

NCT ID NCT06713577

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how well a new type of tooth-colored ceramic (3D shaded zirconia) works for making dental crowns, onlays, and bridges in a single dental visit using a computer design and milling machine. About 82 adults aged 18 to 75 who need a crown or onlay on a back tooth will get the restoration and be checked for up to 5 years. The goal is to see if the material stays strong, looks good, and keeps the tooth healthy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 82 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Nov 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The patient population will be selected from current patients of either gender and any ethnic background, under clinical treatment at the University of Michigan Dental Clinics.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult aged 18-75 years. * Willing and able to sign and date the informed consent form and the HIPAA form. * Onlays and Crowns: Each patient should have at least one carious lesion, defective restoration, or fractured portion of the tooth to be restored on a maxillary or mandibular premolar or molar tooth. Each lesion, fracture, or defective restoration should exhibit sufficient size or loss of tooth structure requiring an onlay or crown restoration. The tooth should have at least one opposing tooth in occlusion and one adjacent tooth with an intact proximal contact. No more than eight teeth that are endodontically treated and restorable with an onlay or crown may be included in the study. All remaining teeth in the study will test vital and be asymptomatic at the beginning of treatment. No more than two restorations will be placed per patient. If a patient presents with more than two acceptable teeth for the study, molar teeth will be included prior to premolar teeth. * Fixed Partial Dentures (FPDs): Each patient should have at least one missing tooth, either anterior or posterior, that is appropriate for replacement with a fixed partial denture. Abutment teeth will have healthy periodontal status with at least a 1:1 crown:root ratio. The FPD should have at least two opposing teeth in occlusion and one adjacent tooth with an intact proximal contact. Both abutment teeth must be asymptomatic prior to treatment. Endodontically treated teeth will be acceptable for abutments if nonmetallic cores can be placed to retain the FPD. FPDs may include 3 or 4 teeth as indicated by the clinical situation but must be within the 43 mm span of the mill block to manufacture it as described later. The patient cohort should include a mix of non-endodontically as well as endodontically treated teeth. Exclusion Criteria: * Unlikely to be able to comply with clinical study procedures, according to Principal Investigator's (PIs) judgment. * Subject is not willing to participate in the clinical study. * Patients unable to return for the recall appointments for a period of 5 years. * Severe non-compliance to the clinical study plan as judged by the PI and/or Dentsply Sirona. * Involvement in the planning and conduct of the clinical study. Applies to both Dentsply Sirona personnel and personnel from the clinical study site. * Sensitive teeth. * Teeth diagnosed with symptoms of incomplete tooth fracture. * 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 history of allergies to the materials to be used in the study including composite resin cements, provisional acrylics, or zirconia restorative materials.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Department of Cariology, Restorative Sciences, and Endodontics at School of Dentistry

    Ann Arbor, Michigan, 48109-1078, United States

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Other studies related to the condition(s) this trial covers.