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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new resin-based ceramic material called Tetric CAD for dental crowns. The goal is to evaluate the long-term performance of these crowns, which can be made and fitted in a single visit without a temporary crown. Ideal participants have a molar or premolar requiring a full crown due to decay or fracture. The trial focuses on teeth that are healthy and not sensitive before treatment. As an unphased trial, it offers participants the chance to experience innovative dental technology that could simplify and improve dental care.

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 prior data suggests that this ceramic crown technique is safe for tooth restoration?

Research has shown that ceramic crowns, such as those made from Tetric CAD, are generally safe for people. They are biocompatible, meaning they do not harm human tissues. The FDA has approved Tetric CAD for patient use, confirming it meets safety standards.

Dental professionals should take precautions when using Tetric CAD during the finishing process. They should use suction equipment and wear a dust mask to avoid inhaling dust. These precautions ensure the safety of dental professionals and are unrelated to the safety of the crowns once in place.

Overall, Tetric CAD crowns have a good safety record and are well-tolerated by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Tetric CAD crowns for tooth restoration because they offer a new approach to dental crowns. Unlike traditional metal or porcelain crowns, Tetric CAD crowns are made from a ceramic material that is hand-polished for a more natural appearance and feel. This material is cemented using a dual-cured resin cement, which may enhance the crown's durability and bond strength. These features could lead to better aesthetics and potentially longer-lasting results compared to conventional options.

What evidence suggests that Tetric CAD crowns are effective for tooth restoration?

Research has shown that ceramic crowns, such as those made from Tetric CAD, are safe and compatible with the human body. Studies indicate that these computer-designed ceramic crowns can last a long time, with survival rates of up to 94.66% at 3 years, 91.1% at 5 years, and 82.2% at 10 years. The Tetric CAD material is designed to quickly produce single-tooth crowns, reducing the number of necessary dental visits. Clinical success rates for these crowns reach 86.7% after 24 months. Overall, Tetric CAD crowns are expected to be a strong and long-lasting option for tooth restoration. ^{2 4 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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. withpower.com withpower.com/trial/phase-dental-caries-9-2018-15b3e

Ceramic Crowns for Tooth Restoration · Info for Participants 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5022219/

Comparative in vitro evaluation of CAD/CAM vs ... CAD/CAM fabricated provisional crowns demonstrated superior fit and better strength than direct provisional crowns. Keywords: Temporary dental restoration, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8161295/

Clinical Performance of CAD/CAM All-Ceramic Tooth ... We estimated survival rates of up to 94.66%, 91.1%, and 82.2% for the 3-, 5-, and 10-year survival data based on the available evidence in the literature. The ...

4. ivoclar.com ivoclar.com/medias/tetric-cad-scidocs-us-en.pdf?context=bWFzdGVyfGNlbHVtLWNvbm5lY3QyLWFzc2V0c3wyMDM0NTUwfGFwcGxpY2F0aW9uL3BkZnxjZWx1bS1jb25uZWN0Mi1hc3NldHMvaGUxL2gyNS8xMDM3MTQ5NDM0Njc4Mi5wZGZ8MmFiYzAwNzdmNGY3Zjk2Y2ZjY2QyYjExZTk4MGI0YzU2Yjc0ODUxOTdmNjlmMmI0Mjk3YzdjMmY5NDQ0NTE5MQ

Tetric® CAD Tetric CAD is an esthetic composite block for creating single-tooth restorations efficiently via the CAD/CAM technique. The material is industrially produced ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jerd.13371

Advances in Dental Restorations: A Comprehensive ... Clinical success of CAD-CAM machinable CRC was shown to be 86.7% after 24 months for single tooth restorations [55]. The clinical performance ...

6. ivodent.hu ivodent.hu/__docs/714_43401012ee9a338d903ddae5d3636ed9.pdf

Tetric® CAD Do not inhale the composite resin dust during finishing. Use suction equipment and wear a dust mask. Observe the information in the Safety Data Sheet (SDS).

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf17/K173573.pdf

Ivoclar Vivadent AG June7, 2018 Donna Hartnett Director QA ... Tetric CAD is a composite block for esthetic permanent inlays, onlays, veneers, and crowns in the anterior and posterior region.

8. pattersondental.com pattersondental.com/en-CA/Supplies/cad-cam-blocks-block-kits/cad-cam-blocks/tetric-cad-for-planmill-blocks/PIF_839502

MT (Medium Translucency), 5/Pkg - Ivoclar Vivadent Inc Tetric® CAD for Planmill are esthetic hybrid ceramic resin blocks for single-tooth restorations. Restorations blend in with residual tooth structure for a ...