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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from delivery of the crown up to 5 years
Awards & highlights
Study 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 belowSelect...
I need a full crown because more than half of my tooth's width is damaged.
Select...
I have at least one cavity, broken filling, or cracked tooth in my back teeth.
Select...
My teeth are healthy and I have no tooth pain.
Select...
I need a full crown because more than half of my tooth's width is damaged.
Select...
I will have no more than two teeth restored for this study, prioritizing molars over premolars.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from delivery of the crown up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from delivery of the crown up to 5 years
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).
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Who is running the clinical trial?
University of MichiganLead Sponsor
1,794 Previous Clinical Trials
6,373,866 Total Patients Enrolled
Ivoclar Vivadent AGIndustry Sponsor
33 Previous Clinical Trials
2,122 Total Patients Enrolled
Dennis Fasbinder, DDSPrincipal InvestigatorUniversity of Michigan
4 Previous Clinical Trials
314 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need a full crown because more than half of my tooth's width is damaged.I have at least one cavity, broken filling, or cracked tooth in my back teeth.I have at least one cavity, broken filling, or cracked tooth in my back teeth.I have dead or sensitive teeth.My teeth are healthy and I have no tooth pain.I need a full crown because more than half of my tooth's width is damaged.I will have no more than two teeth restored for this study, prioritizing molars over premolars.I have major untreated dental issues like gum disease or severe cavities.I cannot come back for follow-up appointments.
Research Study Groups:
This trial has the following groups:- Group 1: Tetric CAD Crown
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any enrolment opportunities available for this research?
"The most recent update on clinicaltrials.gov informs us that this study is no longer accepting patients, having first been posted October 1st 2018 and last edited September 6th 2022. Fortunately for those seeking treatment options, 104 other medical trials are currently enrolling candidates."
Answered by AI
Who else is applying?
What site did they apply to?
University of Michigan School of Dentistry
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
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