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 trial tests new dental crowns made from a special zirconia material, installed using two different methods. The goal is to evaluate the effectiveness of these crowns over two years. Eligible participants must have a damaged tooth needing a crown, with at least one tooth touching it when they bite and another tooth adjacent to it. Participants should not have sensitive teeth, untreated major dental issues, or allergies to crown materials. This trial will help determine which crown application method may be best for future dental treatments. As an unphased trial, participants contribute to advancing dental care innovations and may benefit from cutting-edge treatment options.

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.

What prior data suggests that these chairside CAD/CAM crowns are safe for dental use?

Studies have shown that SpeedCEM Plus, a type of dental cement, is safe and well-tolerated. Clinical reviews found no issues with sensitivity after its use, and it maintained an excellent appearance for two years.

For ZirCAD Cement, research indicates it performs well with zirconia crowns. Most crowns remained secure with positive results for up to 24 months. Both cements seem safe and effective for dental treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the chairside CAD/CAM crowns because they offer a faster and more convenient way to treat dental disease compared to traditional crowns. These crowns can be crafted and fitted in a single dental visit, eliminating the need for multiple appointments. The SpeedCEM Plus luted crowns use a self-adhesive, self-curing resin cement, which simplifies the placement process and may enhance bonding strength. On the other hand, the ZirCAD Cement cemented crowns employ a resin-modified glass ionomer cement, potentially offering improved durability and biocompatibility. Together, these innovations could lead to more efficient and patient-friendly dental care.

What evidence suggests that this trial's treatments could be effective for dental disease?

Research has shown that monolithic zirconia crowns, like those used in this study, can last up to 7 years and serve as a strong alternative to metal ceramic crowns. In this trial, participants will receive crowns attached with either SpeedCEM Plus or ZirCAD Cement. Studies have found that SpeedCEM Plus resin cement works well and is easy to use, making it a reliable choice for zirconia crowns. Similarly, ZirCAD Cement has supported crowns effectively, with no breaks reported in single-tooth zirconia crowns and a high success rate overall. Known for their strength and resistance to wear, monolithic zirconia crowns lead to high patient satisfaction. Overall, crowns made with these materials are durable and perform well over time. ^{1 4 5 6 7}

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

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]

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 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]

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]

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 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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06173167

Clinical Evaluation of Full Contour Zirconia Chairside CAD ... 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.

2. dentaladvisor.com dentaladvisor.com/clinical-evaluation/speedcem%C2%ACae-plus-2-yr/

SpeedCEM® Plus (2 yr.) SpeedCEM® Plus is a self-adhesive, self-curing resin cement with a light-curing option. This cement offers an ideal combination of performance and ease of ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06173167?spons=COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22University%20of%20Michigan%22)&viewType=Table&rank=6

Clinical Evaluation of Full Contour Zirconia Chairside CAD ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39814379/

Outcomes of surveyed monolithic CAD/CAM zirconia ... Surveyed monolithic zirconia crowns demonstrated high survival after 7 years of service. Monolithic zirconia is an excellent alternative to metal ceramic ...

5. ivoclar.com ivoclar.com/en_us/products/cementation/speedcem-plus

Speedcem Plus | Self-adhesive cementation Speedcem Plus is a clinically proven self-adhesive resin cement for the permanent seating of high-strength restorations made of zirconia and metal.

6. ivodent.hu ivodent.hu/__docs/792_645b37c8c6d5815dfd8679ea6ccd4755.pdf

Scientific Documentation SpeedCEM Plus is a self-adhesive resin cement that bonds to dentin and certain restorative materials and enables dentists to seat e.g. zirconium oxide ...

7. cdn.vivarep.com cdn.vivarep.com/contrib/vivarep/media/pdf/4_7241_SpeedCEMPlus682342_20211220193154094.pdf

SpeedCEM® Plus SpeedCEM Plus permits flexible use in different situations. It produces a reliable bond on moist and dry dentin - both when used in the self- curing mode and ...