Ceramic 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: 1

Duration: 1 day

50 Participants Needed

Trial Summary

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 unlikely that your regular medications would be affected, but you should confirm with the trial organizers.

What data supports the effectiveness of the treatment Tetric CAD for Ceramic Crowns for Tooth Restoration?

Research shows that CAD/CAM ceramic crowns, like Tetric CAD, are becoming popular due to their improved mechanical properties and appearance compared to older metal-ceramic crowns. These crowns are designed to fit well and withstand wear from chewing, making them a reliable choice for tooth restoration. ^{1 2 3 4 5}

Is it safe to use ceramic crowns for tooth restoration?

Research shows that ceramic crowns, including those made from Tetric CAD, are generally safe for use in humans. They are biocompatible, meaning they do not harm human cells, and they support cell attachment and growth. ^{2 6 7 8 9}

How does the treatment Tetric CAD for ceramic crowns differ from other treatments?

Tetric CAD is unique because it uses computer-aided design and manufacturing (CAD/CAM) technology to create ceramic crowns, which offer improved mechanical properties and aesthetics compared to traditional ceramo-metal crowns. This technology allows for precise customization and better fit, potentially reducing wear and improving the longevity of the crowns. ^{1 5 10 11 12}

What is the purpose of this trial?

This investigation will be a clinical trial to study the performance of a new resin-based ceramic material for crowns. The material 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. The purpose of the study is to measure how well the high strength crowns function over an extended period of time.

Research Team

Dennis Fasbinder, DDS

Principal Investigator

University of Michigan

Eligibility Criteria

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.

Inclusion 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.

Exclusion Criteria

Patients with a history of allergies to any of the materials to be used in the study

I have dead or sensitive teeth.

Teeth with a history of direct or indirect pulp capping procedures

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Placement of Tetric CAD crowns using an adhesive bonding process

1 day

1 visit (in-person)

Follow-up

Participants are monitored for crown performance, including evaluations at 6 months, 1 year, 2 years, 3 years, and potentially 4 and 5 years

5 years

Multiple visits (in-person) at specified intervals

Treatment Details

Interventions

• Tetric CAD

Trial Overview 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.

Participant Groups

Group I: Tetric CAD Crown Experimental Treatment 1 Intervention

Tetri CAD crowns will hand polished and cemented with a dual cured resin cement (Variolink Esthetic by Ivoclar Vivadent).

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Ivoclar Vivadent AG

Industry Sponsor

Trials

38

Recruited

2,400+

References

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

Combined Stereophotogrammetry and Laser-Sintered, Computer-Aided Milling Framework for an Implant-Supported Mandibular Prosthesis: A Case History Report. [2018]

2. 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]

3. China pubmed.ncbi.nlm.nih.gov

[Comparative evaluation of the marginal accuracy of single crowns fabricated computer using aided design/computer aided manufacturing methods, self-curing resin and Luxatemp]. [2020]

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

Comparison of the morphological accuracy of automatic crowns designed by multiple computer-aided design software programs with different levels of dentition information acquisition. [2023]

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

Effect of Simulated Mastication on the Surface Roughness and Wear of Machinable Ceramics and Opposing Dental Enamel. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

The Biological Activity of Fragmented Computer-Aided Design/Manufacturing Dental Materials before and after Exposure to Acidic Environment. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Marginal Adaptation and Fracture Resistance of 3D Printed and CAD/CAM Milled Definitive Resin Matrix Ceramic Crowns. [2023]

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

Survival of In-Ceram crowns in a private practice: a prospective clinical trial. [2019]

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

Clinical assessment of high-strength all-ceramic crowns. [2019]

10. Germany pubmed.ncbi.nlm.nih.gov

Comparison of occlusal contact errors of 6 chairside CAD/CAM crowns: a self-controlled clinical study. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Digital assessment of marginal accuracy in ceramic crowns fabricated with different marginal finish line configurations. [2022]

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

Prospective observation of CAD/CAM titanium ceramic single crowns: a three-year follow up. [2013]