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

48 Participants Needed

Trial Summary

What is the purpose of this trial?

This investigation will be a clinical trial to study the performance of a newly developed high strength ceramic material for crowns. The ceramic has been approved by the FDA for patient treatment. A computer technique will be used to fabricate the crowns in a single appointment without the need for a temporary crown or second appointment. Two adhesive resin cement techniques will be used to hold the crown to the tooth and they will be evaluated for creating sensitivity to the tooth. The purpose of the study is to measure how well the high strength crowns function over an extended period of time.

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 data supports the effectiveness of the treatment Celtra Quatro for tooth restoration?

The study on CAD-CAM-generated ceramic inlays shows that similar ceramic restorations have high success rates in terms of color matching, durability, and minimal wear over four years, suggesting that Celtra Quatro crowns, which are also ceramic, may offer similar benefits for tooth restoration. ^{1 2 3 4 5}

Is Celtra Quatro safe for use in dental treatments?

Dental materials, including those used for tooth restoration, are generally considered safe with very few reports of adverse reactions. Monitoring and regulations help ensure their safety, although some materials may contain substances that could potentially cause reactions. ^{6 7 8 9 10}

How does the Celtra Quatro treatment for tooth restoration differ from other treatments?

Celtra Quatro crowns are unique because they are made from a high-strength ceramic material that offers both durability and aesthetic appeal, making them suitable for restoring teeth with a natural look. Unlike some other materials, Celtra Quatro provides a balance of strength and translucency, which can be advantageous for both functional and cosmetic dental restorations. ^{11 12 13 14 15}

Research Team

Dennis Fasbinder, DDS

Principal Investigator

University of Michigan

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

References

1. England pubmed.ncbi.nlm.nih.gov

The survival of indirect composite resin onlays for the restoration of root filled teeth: a retrospective medium-term study. [2014]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Retrospective study of fracture survival in endodontically treated molars: the effect of single-unit crowns versus direct-resin composite restorations. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

An 18-year retrospective evaluation of glass-infiltrated alumina crowns. [2021]

4. England pubmed.ncbi.nlm.nih.gov

The clinical performance of CAD-CAM-generated ceramic inlays: a four-year study. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Potential complications of CAD/CAM-produced resin composite crowns on molars: A retrospective cohort study over four years. [2022]

6. Denmark pubmed.ncbi.nlm.nih.gov

Reporting on adverse reactions to dental materials--intraoral observations at a clinical follow-up. [2019]

7. India pubmed.ncbi.nlm.nih.gov

The leakage of Class II cavities restored with packable resin-based composites. [2010]

8. Brazil pubmed.ncbi.nlm.nih.gov

Proposal of a trigger tool to assess adverse events in dental care. [2019]

9. England pubmed.ncbi.nlm.nih.gov

The national survey of adverse reactions to dental materials in the UK: a preliminary study by the UK Adverse Reactions Reporting Project. [2016]

10. England pubmed.ncbi.nlm.nih.gov

The safety and biocompatibility of direct aesthetic restorative materials. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

Three-year results of a randomized controlled clinical trial of the posterior composite QuiXfil in class I and II cavities. [2018]

12. Germany pubmed.ncbi.nlm.nih.gov

Two-year clinical performance of a nanofiller vs a fine-particle hybrid resin composite. [2018]

13. Netherlands pubmed.ncbi.nlm.nih.gov

[An evaluation of completely ceramic crowns]. [2019]

14. Switzerland pubmed.ncbi.nlm.nih.gov

[The marginal adaptation of mechanically produced onlays in vitro]. [2016]

15. Switzerland pubmed.ncbi.nlm.nih.gov

[Rehabilitation of an abraded occlusion with Procera-ZrO2 all-ceramic crowns. A case report]. [2016]