Dental Crowns for Dental Disease

Overseen By Dennis J. Fasbinder, DDS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ivoclar Vivadent AG

Disqualifiers: Sensitive teeth, Untreated dental disease, Pregnancy, Allergies, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This investigation will be a randomized, prospective, longitudinal clinical trial to study the clinical performance of a new monolithic, zirconia material with shade, translucency and material graduation for chairside CAD/CAM crowns. The restorations will be luted either with a self-adhesive luting material or a conventional cement. The crowns will be evaluated for a period of two years.

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 conditions, so it's best to ask the trial organizers for more details.

Is it safe to use zirconia crowns for dental treatments?

The available research does not specifically address safety concerns for zirconia crowns, but they are widely used in dentistry due to their high strength and durability, suggesting they are generally considered safe for use in humans. ^{1 2 3 4 5}

What makes Chairside CAD/CAM Crowns unique compared to other dental treatments?

Chairside CAD/CAM Crowns are unique because they allow for the creation of zirconia crowns in a single dental visit using computer-aided design and manufacturing technology, eliminating the need for multiple appointments and providing a quick and efficient restoration option. ^{1 3 5 6 7}

What data supports the effectiveness of the treatment Chairside CAD/CAM Crowns, Full Contour Zirconia Crowns, Monolithic Zirconia Crowns, Zirconia Chairside CAD/CAM Crowns for dental disease?

Research shows that monolithic zirconia crowns, which are made using computer-aided design and manufacturing (CAD-CAM), have been effective in dental treatments due to their high strength and good fit. They are commonly used for restoring teeth and have shown good clinical performance and durability over time. ^{3 4 5 6 8}

Who Is on the Research Team?

Dennis J. Fasbinder, DDS

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for adults with certain oral conditions needing a full crown restoration on premolar or molar teeth. Participants must have at least one opposing tooth and an adjacent tooth with intact contact. No more than two crowns per person, and only ten participants can have endodontically treated teeth.

Inclusion Criteria

I will receive no more than two dental restorations.

I have no more than 10 root canal treated teeth.

I have at least one tooth that touches another when I bite down.

Exclusion Criteria

Sensitive teeth

Teeth with a history of direct or indirect pulp capping procedures

Patients with a self-reported history of allergies to the materials to be used in the study including composite resin cements or zirconia restorative materials

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive chairside CAD/CAM crowns using either a self-adhesive luting material or a conventional cement

4 weeks

Weekly feedback visits

Follow-up

Participants are monitored for clinical performance of the crowns, including post-operative sensitivity and quality criteria

2 years

Regular evaluations based on FDI criteria

What Are the Treatments Tested in This Trial?

Interventions

• Chairside CAD/CAM Crowns

Trial Overview The study tests new monolithic zirconia CAD/CAM crowns luted either self-adhesively or conventionally cemented. It's randomized, comparing the clinical performance of both methods over two years to see which is better.

How Is the Trial Designed?

Group I: ZirCAD Cement cemented crowns Experimental Treatment 1 Intervention

crowns delivered with a resin modified glass ionomer cement (ZirCAD Cement\\Ivoclar Vivadent AG)

Group II: SpeedCEM Plus luted crowns Experimental Treatment 1 Intervention

crowns delivered with a self-adhesive, self-curing resin cement (SpeedCEM Plus\\Ivoclar Vivadent AG)

Chairside CAD/CAM Crowns is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Full Contour Zirconia Crowns for:

• Single-unit crowns
• Multi-unit bridges
• Posterior crowns
• Anterior crowns

Approved in United States as Monolithic Zirconia Crowns for:

• Single-unit crowns
• Multi-unit bridges
• Posterior crowns
• Anterior crowns

Approved in Canada as Zirconia Chairside CAD/CAM Crowns for:

• Single-unit crowns
• Multi-unit bridges
• Posterior crowns
• Anterior crowns

Approved in Japan as Full Contour Zirconia Crowns for:

• Single-unit crowns
• Multi-unit bridges
• Posterior crowns
• Anterior crowns

Who Is Running the Clinical Trial?

Ivoclar Vivadent AG

Lead Sponsor

Trials

38

Recruited

2,400+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Published Research Related to This Trial

The study found that the vertical marginal discrepancy (VMD) of CAD-CAM fabricated monolithic zirconia crowns was significantly affected by the cementation process, which increased the VMD to an average of 60 μm, compared to 38 μm for both the post-sintering and post-glazing stages.

Glazing did not significantly alter the VMD of the crowns, indicating that the initial fabrication stages (sintering and glazing) maintain a consistent fit, while the cementation process is critical for ensuring proper alignment and fit of the crowns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of fabrication stages and cementation on the marginal fit of CAD-CAM monolithic zirconia crowns. Kale, E., Yilmaz, B., Seker, E., et al.[2018]

In a study involving 60 patients, full-contour monolithic zirconia crowns demonstrated a 100% survival rate over a 1-year period, indicating excellent clinical performance.

The wear on opposing natural teeth was minimal, with statistically significant increases in wear observed at 6 months and 12 months, suggesting that MZ crowns are safe for enamel wear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Antagonist Enamel Wear and Clinical Performance of Full-Contour Monolithic Zirconia Crowns: One-Year Results of a Prospective Study. Pathan, MS., Kheur, MG., Patankar, AH., et al.[2019]

A study involving 214 patients showed that chairside monolithic lithium disilicate glass-ceramic CAD-CAM crowns have a high cumulative survival rate of 91.06% after 36 months, indicating their durability and effectiveness as a dental restoration option.

The crowns demonstrated excellent esthetic outcomes, with high scores for color, shape, and chewing ability throughout the 36-month follow-up, and their survival rate was not significantly influenced by factors such as gender, age, or pulp condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical performance of chairside monolithic lithium disilicate glass-ceramic CAD-CAM crowns]. Chen, YJ., Yao, Y., Luo, AX.[2021]

In an in vitro study involving 15 maxillary first molar typodont teeth, it was found that the cement space set in CAD software significantly affects the marginal fit of CAD-CAM-fabricated monolithic zirconia crowns, with a notable improvement in fit as the cement space decreased.

The study revealed that crowns with a cement space of 50 μm had the best marginal fit (53 μm discrepancy), while those with a 30 μm space had a higher discrepancy (85 μm), indicating that careful adjustment of cement space is crucial for optimal crown fit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of cement space on the marginal fit of CAD-CAM-fabricated monolithic zirconia crowns. Kale, E., Seker, E., Yilmaz, B., et al.[2022]

Zirconia is increasingly used in dentistry due to its high strength, initially as a substructure material and now also in monolithic designs.

Advancements in chairside CAD/CAM technology allow dentists to create and deliver 3-unit zirconia bridges in just one appointment, enhancing patient convenience and treatment efficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Full-Contour Zirconia Fixed Partial Dentures as Chairside Applications: A Case Report. Skramstad, M., Fasbinder, DJ.[2017]

Crowns made from fully sintered zirconia blocks using a chairside CAD-CAM system showed acceptable trueness for clinical use, although they were slightly less accurate (43.0 μm) compared to those made in a laboratory setting (37.4 μm).

The chairside milling process was significantly faster, taking only 0.52 hours compared to 1.42 hours for laboratory milling, highlighting its efficiency for single-visit dental restorations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trueness of the Inner Surface of Monolithic Crowns Fabricated by Milling of a Fully Sintered (Y, Nb)-TZP Block in Chairside CAD-CAM System for Single-visit Dentistry. Cho, JH., Yoon, HI., Han, JS., et al.[2020]

In an in vitro study of 32 zirconia crowns, those veneered with CAD/CAM manufactured lithium disilicate ceramic showed significantly better durability, with 87.5% of conventionally veneered crowns failing during chewing simulation, while CAD/CAM crowns remained intact.

The CAD/CAM veneered crowns demonstrated an ultimate load to failure of approximately 1600 N, indicating their strong resistance to material fatigue and suggesting a promising approach for improving the longevity of dental restorations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chipping behaviour of all-ceramic crowns with zirconia framework and CAD/CAM manufactured veneer. Schmitter, M., Mueller, D., Rues, S.[2022]

In a clinical trial involving 60 patients, both types of posterior zirconia-ceramic fixed dental prostheses (FDPs) showed a 100% survival rate after a mean follow-up of 13.9 months, indicating high efficacy for both materials.

While both FDP types experienced chipping, the CAD/CAM lithium disilicate veneered prostheses had predominantly minor chipping, whereas the manually layered zirconia veneered prostheses had instances of major chipping, suggesting a potential advantage in durability for the CAD-on approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-unit posterior zirconia-ceramic fixed dental prostheses (FDPs) veneered with layered and milled (CAD-on) veneering ceramics: 1-year follow-up of a randomized controlled clinical trial. Grohmann, P., Bindl, A., Hämmerle, C., et al.[2021]

Citations

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

Effect of fabrication stages and cementation on the marginal fit of CAD-CAM monolithic zirconia crowns. [2018]

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

Assessment of Antagonist Enamel Wear and Clinical Performance of Full-Contour Monolithic Zirconia Crowns: One-Year Results of a Prospective Study. [2019]

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

[Clinical performance of chairside monolithic lithium disilicate glass-ceramic CAD-CAM crowns]. [2021]

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

Effect of cement space on the marginal fit of CAD-CAM-fabricated monolithic zirconia crowns. [2022]

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

Full-Contour Zirconia Fixed Partial Dentures as Chairside Applications: A Case Report. [2017]

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

Trueness of the Inner Surface of Monolithic Crowns Fabricated by Milling of a Fully Sintered (Y, Nb)-TZP Block in Chairside CAD-CAM System for Single-visit Dentistry. [2020]

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

Chipping behaviour of all-ceramic crowns with zirconia framework and CAD/CAM manufactured veneer. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Three-unit posterior zirconia-ceramic fixed dental prostheses (FDPs) veneered with layered and milled (CAD-on) veneering ceramics: 1-year follow-up of a randomized controlled clinical trial. [2021]