70 Participants Needed

Dental Crowns for Dental Disease

DJ
Overseen ByDennis J. Fasbinder, DDS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Ivoclar Vivadent AG
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

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

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.12345

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.12567

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.12368

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.

Research Team

DJ

Dennis J. Fasbinder, DDS

Principal Investigator

University of Michigan

Eligibility Criteria

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.
See 1 more

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
See 3 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: ZirCAD Cement cemented crownsExperimental Treatment1 Intervention
crowns delivered with a resin modified glass ionomer cement (ZirCAD Cement\\Ivoclar Vivadent AG)
Group II: SpeedCEM Plus luted crownsExperimental Treatment1 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:

πŸ‡ͺπŸ‡Ί
Approved in European Union as Full Contour Zirconia Crowns for:
  • Single-unit crowns
  • Multi-unit bridges
  • Posterior crowns
  • Anterior crowns
πŸ‡ΊπŸ‡Έ
Approved in United States as Monolithic Zirconia Crowns for:
  • Single-unit crowns
  • Multi-unit bridges
  • Posterior crowns
  • Anterior crowns
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Approved in Canada as Zirconia Chairside CAD/CAM Crowns for:
  • Single-unit crowns
  • Multi-unit bridges
  • Posterior crowns
  • Anterior crowns
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Approved in Japan as Full Contour Zirconia Crowns for:
  • Single-unit crowns
  • Multi-unit bridges
  • Posterior crowns
  • Anterior crowns

Find a Clinic Near You

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+

Findings from Research

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 ΞΌm, compared to 38 ΞΌm 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.
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.
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.
[Clinical performance of chairside monolithic lithium disilicate glass-ceramic CAD-CAM crowns].Chen, YJ., Yao, Y., Luo, AX.[2021]

References

Effect of fabrication stages and cementation on the marginal fit of CAD-CAM monolithic zirconia crowns. [2018]
Assessment of Antagonist Enamel Wear and Clinical Performance of Full-Contour Monolithic Zirconia Crowns: One-Year Results of a Prospective Study. [2019]
[Clinical performance of chairside monolithic lithium disilicate glass-ceramic CAD-CAM crowns]. [2021]
Effect of cement space on the marginal fit of CAD-CAM-fabricated monolithic zirconia crowns. [2022]
Full-Contour Zirconia Fixed Partial Dentures as Chairside Applications: A Case Report. [2017]
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]
Chipping behaviour of all-ceramic crowns with zirconia framework and CAD/CAM manufactured veneer. [2022]
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]
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