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Resin-based Ceramic Material

Ceramic Crowns for Tooth Restoration

N/A
Waitlist Available
Led By Dennis Fasbinder, DDS
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
reason for restoration should extend more than one-half the intercuspal width of the tooth requiring a full crown restoration
Must have at least one carious lesion or defective restoration or fractured tooth in a molar or premolar
Must not have
Devital or sensitive teeth
Patients with significant untreated dental disease to include periodontitis and rampant caries
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from delivery of the crown up to 5 years
Awards & highlights

Summary

This trial will study how well a new, FDA-approved type of ceramic crown works. The crowns will be made in a single appointment using a computer technique, and their performance will be monitored over time.

Who is the study for?
This trial is for individuals needing crowns due to tooth decay, fractures, or unsatisfactory restorations. Eligible participants should have one or two teeth requiring full crown restoration in molars or premolars that are vital and symptom-free. Those with devitalized/sensitive teeth, prior endodontic treatments, significant untreated dental disease, allergies to materials used in the study, or who are pregnant/lactating cannot participate.Check my eligibility
What is being tested?
The TetricCAD Crown Clinical Study tests a new FDA-approved resin-based ceramic material for crowns made using computer technology in a single appointment. The study aims to evaluate the long-term functionality of these high-strength crowns without the need for temporaries or follow-up fittings.See study design
What are the potential side effects?
While specific side effects aren't listed for this dental procedure, typical risks may include sensitivity around the treated area, discomfort from biting adjustments needed after crown placement and potential allergic reactions to materials used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I need a full crown because more than half of my tooth's width is damaged.
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I have at least one cavity, broken filling, or cracked tooth in my back teeth.
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My teeth are healthy and I have no tooth pain.
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I need a full crown because more than half of my tooth's width is damaged.
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I will have no more than two teeth restored for this study, prioritizing molars over premolars.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have dead or sensitive teeth.
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I have major untreated dental issues like gum disease or severe cavities.
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I cannot come back for follow-up appointments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from delivery of the crown up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from delivery of the crown up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Crown failure
Secondary outcome measures
Crown loss of retention
Margin staining
Tooth sensitivity

Trial Design

1Treatment groups
Experimental Treatment
Group I: Tetric CAD CrownExperimental Treatment1 Intervention
Tetri CAD crowns will hand polished and cemented with a dual cured resin cement (Variolink Esthetic by Ivoclar Vivadent).

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,817 Previous Clinical Trials
6,387,312 Total Patients Enrolled
Ivoclar Vivadent AGIndustry Sponsor
35 Previous Clinical Trials
2,209 Total Patients Enrolled
Dennis Fasbinder, DDSPrincipal InvestigatorUniversity of Michigan
4 Previous Clinical Trials
314 Total Patients Enrolled

Media Library

Tetric CAD (Resin-based Ceramic Material) Clinical Trial Eligibility Overview. Trial Name: NCT03716817 — N/A
Unsatisfactory Tooth Restoration Research Study Groups: Tetric CAD Crown
Unsatisfactory Tooth Restoration Clinical Trial 2023: Tetric CAD Highlights & Side Effects. Trial Name: NCT03716817 — N/A
Tetric CAD (Resin-based Ceramic Material) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03716817 — N/A
~14 spots leftby Oct 2026