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Ceramic Material

Celtra Quatro 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
Teeth to be vital and asymptomatic prior to treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from delivery of crown up to 5 years
Awards & highlights

Study Summary

This trial will study a newly developed, strong ceramic material for crowns. The material has been approved by the FDA, and the crowns can be made in a single appointment without the need for a temporary crown or second appointment.

Who is the study for?
This trial is for individuals with a tooth needing restoration due to decay, fractures, or cavities. Eligible teeth must be vital and symptom-free, with the need for a full crown. Participants can have up to two restorations in this study but cannot join if they're allergic to materials used, have had certain dental treatments, are pregnant or breastfeeding, or can't attend follow-up appointments.Check my eligibility
What is being tested?
The Celtra Quatro Crown Study tests a new FDA-approved ceramic material for crowns that's made using computer technology in one visit without temporary crowns. The study compares two adhesive techniques to see how well they prevent sensitivity and how durable the crowns are over time.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects may include tooth sensitivity or discomfort related to the adhesive resin cement techniques used to attach the crown.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I need a full crown because more than half of my tooth's width is damaged.
Select...
My teeth are healthy and pain-free before starting treatment.
Select...
I have at least one cavity, broken filling, or cracked tooth in my back teeth.

Timeline

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

4Treatment groups
Experimental Treatment
Group I: Crown, 1.5mm thickness, dual cure resin cementExperimental Treatment1 Intervention
occlusal thickness of 1.5 mm delivered with Prime and Bond elect Universal Bond in total etch mode with a dual cure resin cement
Group II: Crown, 1.5mm thickness, Calcium Aluminate Ionomer CementExperimental Treatment1 Intervention
occlusal thickness of 1.5 mm delivered with a conventional Calcium Aluminate Ionomer cement
Group III: Crown, 1.0mm thickness, dual cure resin cementExperimental Treatment1 Intervention
occlusal thickness of 1.0 mm delivered with Prime and Bond elect Universal Bond in total etch mode with a dual cure resin cement
Group IV: Crown, 1.0mm thickness, Calcium Aluminate Ionomer CementExperimental Treatment1 Intervention
occlusal thickness of 1.0 mm delivered with a conventional Calcium Aluminate Ionomer cement

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,800 Previous Clinical Trials
6,379,092 Total Patients Enrolled
Dentsply Sirona Implants and ConsumablesIndustry Sponsor
65 Previous Clinical Trials
4,702 Total Patients Enrolled
Dentsply Sirona ImplantsIndustry Sponsor
62 Previous Clinical Trials
4,607 Total Patients Enrolled

Media Library

Celtra Quatro (Ceramic Material) Clinical Trial Eligibility Overview. Trial Name: NCT04604301 — N/A
Unsatisfactory Tooth Restoration Research Study Groups: Crown, 1.5mm thickness, dual cure resin cement, Crown, 1.0mm thickness, Calcium Aluminate Ionomer Cement, Crown, 1.5mm thickness, Calcium Aluminate Ionomer Cement, Crown, 1.0mm thickness, dual cure resin cement
Unsatisfactory Tooth Restoration Clinical Trial 2023: Celtra Quatro Highlights & Side Effects. Trial Name: NCT04604301 — N/A
Celtra Quatro (Ceramic Material) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04604301 — N/A
Unsatisfactory Tooth Restoration Patient Testimony for trial: Trial Name: NCT04604301 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an opportunity to join this clinical study?

"This clinical trial requires 48 participants, between the ages of 18 and 110 years old, who possess a tooth fracture. Additional entry criteria include having two or fewer restorations per patient; if more than two teeth are suitable for the study then molars must be prioritized over premolars; at least one carious lesion/defective restoration/fractured tooth in either a molar or premolar is also required to participate; finally, any reason for requiring restoration should cover more than half of the intercuspal width of the given tooth that needs full crown placement."

Answered by AI

Is eligibility for the trial restricted to individuals below a certain age?

"This clinical trial is recruiting patients between the ages of 18 and 110. For those aged under 18, there are 56 seperate studies available; for seniors over 65, 31 different trials may be suitable."

Answered by AI

Are enrollment opportunities still available for this research endeavor?

"As per the information on clinicaltrials.gov, this medical study has ceased its recruitment of patients as it was last edited on September 6th 2022 after being initially posted on September 24th 2020. Nevertheless, 104 other trials are presently enrolling participants."

Answered by AI

Who else is applying?

What state do they live in?
West Virginia
What site did they apply to?
School os Dentistry
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I want a pretty smile again.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Celtra Quatro Crown Study
Dennis J. Fasbinder, DDS 2020. "Celtra Quatro Crown Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04604301.
~19 spots leftby Nov 2026
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