Celtra Quatro Crowns for Tooth Restoration

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Devital teeth, Endodontic treatment, Periodontitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of strong ceramic crown, called Celtra Quatro, for tooth restoration. The goal is to evaluate the long-term effectiveness of these crowns, using different attachment methods and assessing any tooth sensitivity. Participants will receive crowns made and placed in a single appointment, eliminating the usual need for a temporary crown or follow-up visit. Candidates for this trial include those with a molar or premolar tooth that has a cavity, requires a full crown, and is not causing pain. As an unphased trial, this study allows participants to experience innovative dental technology firsthand.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on dental health, so it's best to ask the trial organizers for more details.

What prior data suggests that this ceramic material and cement techniques are safe for tooth restoration?

Research shows that the ceramic material in Celtra Quatro crowns has received FDA approval for patient treatment, indicating general safety for humans. Studies have found that these crowns are well-tolerated when used to repair teeth.

For crowns using dual cure resin cement, the material works effectively with various adhesives, often resulting in fewer issues like allergic reactions or sensitivity. Past studies of similar materials have demonstrated good performance over several years, indicating safety and durability.

When using Calcium Aluminate Ionomer Cement, the crowns are designed to be strong and resistant to breaking. This strength reduces the risk of fractures, which can cause oral problems.

Overall, previous studies have found that Celtra Quatro crowns, whether using resin or ionomer cement, perform well. This should provide confidence in their safety for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Celtra Quatro crowns because they offer innovative approaches to tooth restoration with varying thickness and cement types. Unlike traditional crowns, which often use a uniform material and thickness, these crowns explore different combinations, like a 1.5mm thickness with a dual cure resin cement or a 1.0mm thickness with Calcium Aluminate Ionomer cement. This trial aims to understand how these variations affect the durability and performance of dental crowns, potentially leading to more personalized and effective dental restorations. By experimenting with different materials and bonding techniques, Celtra Quatro crowns could provide stronger, longer-lasting solutions for patients needing tooth restoration.

What evidence suggests that this trial's treatments could be effective for tooth restoration?

Research has shown that Celtra Quatro crowns are effective for restoring teeth. In this trial, participants will receive crowns with varying thicknesses and cements. When crowns are 1.5mm thick and use a dual cure resin cement, the material becomes very strong and durable. Studies also indicate that this ceramic is tough and resistant to breaking, making it a reliable choice for dental restoration. For crowns that are 1.0mm thick and use a different type of cement, such as Calcium Aluminate Ionomer Cement, the ceramic still provides sufficient strength despite being thinner, potentially reducing the need for extensive drilling on the tooth. Overall, the Celtra Quatro ceramic is recognized for its strength and aesthetic appeal, making it a promising option for dental crowns. ^{1 5 6 7 8}

Who Is on the Research Team?

Dennis Fasbinder, DDS

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I need a full crown because more than half of my tooth's width is damaged.

My teeth are healthy and pain-free before starting treatment.

I have at least one cavity, broken filling, or cracked tooth in my back teeth.

Exclusion Criteria

I have untreated severe dental issues like gum disease or many cavities.

You have had previous dental procedures involving the pulp of your teeth.

You have had allergic reactions to any of the materials used in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Celtra Quatro crowns prepared and delivered during a single dental appointment using a chairside CAD/CAM system

1 day

1 visit (in-person)

Follow-up

Participants are monitored for crown performance, including sensitivity, crown failure, margin staining, and loss of retention

5 years

Recalled at 6 months and then yearly

What Are the Treatments Tested in This Trial?

Interventions

• Celtra Quatro

Trial Overview 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.

How Is the Trial Designed?

Group I: Crown, 1.5mm thickness, dual cure resin cement Experimental Treatment 1 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 Cement Experimental Treatment 1 Intervention

occlusal thickness of 1.5 mm delivered with a conventional Calcium Aluminate Ionomer cement

Group III: Crown, 1.0mm thickness, dual cure resin cement Experimental Treatment 1 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 Cement Experimental Treatment 1 Intervention

occlusal thickness of 1.0 mm delivered with a conventional Calcium Aluminate Ionomer cement

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Dentsply Sirona Implants and Consumables

Industry Sponsor

Trials

68

Recruited

4,800+

Simon Campion

Dentsply Sirona Implants and Consumables

Chief Executive Officer since 2022

PhD in Chemistry from Texas A&M University

Dr. Patrizia Cavazzoni

Dentsply Sirona Implants and Consumables

Chief Medical Officer

MD from Harvard Medical School

Dentsply Sirona Implants

Industry Sponsor

Trials

63

Recruited

4,600+

Simon Campion

Dentsply Sirona Implants

Chief Executive Officer since 2022

PhD in Chemistry from Texas A&M University

Dr. David Ferguson

Dentsply Sirona Implants

Chief Medical Officer

MD from Harvard Medical School

Citations

1. withpower.com withpower.com/trial/celtra-quatro-crowns-for-tooth-restoration-9b7d7

Celtra Quatro Crowns for Tooth Restoration This investigation will be a clinical trial to study the performance of a newly developed high strength ceramic material for crowns.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9507783/

Restoring Teeth with an Advanced Lithium Disilicate Ceramic This case report highlights the minimally invasive rehabilitation with a new advanced lithium disilicate (ALD) ceramic block.

3. dentaladvisor.com dentaladvisor.com/wp-content/uploads/2005/05/42-03-Navigating-The-Ceramic-Spectrum.pdf

NAVIGATING THE CERAMIC SPECTRUM ◦ Only 1.0mm wall thickness required when adhesively cemented · ◦ 530 MPa of flexural strength · ◦ 2.13 K1c fracture toughness · • Available in ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4402686/

CEREC CAD/CAM Chairside System - PMC CEREC 3 chairside system allows to produce highly aesthetic and reliable restorations in a single visit, while minimizing costs and patient discomfort.

5. operative-dentistry.kglmeridian.com operative-dentistry.kglmeridian.com/downloadpdf/view/journals/odnt/46/4/article-p351_1.pdf

Jul/Aug 2021 Volume 46 Number 4 351-476 - Operative Dentistry During the period of evaluation, 1 crown cemented with glass ionomer cement and 1 crown cemented with resin cement lost retention. Color match, marginal ...

6. assets.dentsplysirona.com assets.dentsplysirona.com/websites/microsites/celtra/Celtra_Press_Instructions_EN.pdf

Celtra Press DFU Celtra® Press is a high-strength zirconia-reinforced lithium silicate glass ceramic material that thanks to its translucent and opalescent properties can be ...

7. henryschein.com henryschein.com/us-en/images/dental/henryschein_cerecguide_2018.pdf

CEREC® Materials Resource Guide It allows the fabrication of restorations with considerably lower wall thicknesses (posterior crowns: minimum 0.6; anterior crowns: minimum 0.4 mm).

8. dentsplysirona.com dentsplysirona.com/content/dam/master/product-procedure-brand-categories/cerec/campaigns-promotions/case-studies/documents/CER-brochure-Prime-Collection-Clinical-Cases-M43-C300-7600-01-EN.pdf.coredownload.pdf

Prime Collection The restoration was then cemented with a conventional RMGI cement, with axial and occlusal wall thicknesses of 1,000 microns and 1,500 microns respectively. A ...