CAD-CAM Dental Crowns for Restorative Dentistry

Overseen By Dennis J. Fasbinder, DDS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ivoclar Vivadent AG

Disqualifiers: Devital teeth, Endodontic treatment, Untreated dental disease, Pregnant, Allergies, 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 new dental crowns made from lithium disilicate, available in various shades. The crowns will be attached using either a self-adhesive resin or a dual-curing resin to determine which method is more effective. The trial targets individuals needing a full crown on a back tooth due to a cavity or broken filling. Eligible participants should have healthy, non-sensitive teeth with no prior root canal treatments.

As an unphased trial, this study allows participants to contribute to advancements in dental care and potentially benefit from innovative crown materials and techniques.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these CAD-CAM dental crowns are safe for use in restorative dentistry?

Research shows that lithium disilicate crowns perform well in dental treatments. Studies have found that these crowns are durable and rarely cause issues.

Two methods exist for attaching these crowns, both yielding good results. The first method uses a self-adhesive called SpeedCem Plus, which provides a strong bond to secure the crown. Testing has proven this method effective.

The second method uses an adhesive called Variolink Esthetic, involving a special glue that hardens with light to hold the crown. Both methods are designed to prevent the crown from detaching or breaking.

Overall, these treatments are safe and reliable. Studies suggest that patients can expect successful and long-lasting results with lithium disilicate crowns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of CAD-CAM lithium disilicate crowns for restorative dentistry because they offer a high-strength, aesthetically pleasing option for dental restorations. Unlike traditional metal or porcelain-fused-to-metal crowns, these crowns can be precisely milled using computer-aided design and manufacturing, allowing for a more personalized fit and reducing chair time. Additionally, the study explores two different cementation methods: one using a self-adhesive, self-curing resin cement and the other an adhesive dual-curing resin cement, potentially offering new insights into durability and ease of use compared to conventional cementation techniques.

What evidence suggests that CAD-CAM crowns are effective for restorative dentistry?

Research shows that lithium disilicate crowns effectively fix teeth. One study demonstrated that these crowns lasted up to 9 years, proving strong and reliable over time. Another study found they rarely caused issues like tooth sensitivity or cavities after placement. In this trial, one group will receive crowns self-adhesively cemented, which have remained in good condition for over 8 years. Another group will receive crowns adhesively luted with dual-curing resin cement, which has yielded good results in similar cases. Overall, lithium disilicate crowns offer a dependable choice for long-lasting dental repairs. ^{2 6 7 8 9}

Who Is on the Research Team?

Dennis J. Fasbinder, DDS

Principal Investigator

University of Michigan School of Dentistry, Department of Cariology, Restorative Sciences & Endodontics

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a cavity or damaged tooth needing a full crown on certain teeth. They must have healthy, symptom-free teeth with at least one opposing and adjacent tooth in good condition. Pregnant women, those allergic to study materials, or unable to attend follow-ups are excluded.

Inclusion Criteria

I have at least one cavity or a need for tooth repair on an upper or lower back tooth.

I need a full crown due to significant tooth damage or decay.

All my teeth are healthy and I have no tooth pain.

Exclusion Criteria

I have dead or sensitive teeth.

I cannot come back for follow-up visits.

I have had treatments to protect the nerve inside my tooth.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

CAD-CAM crowns made of lithium disilicate are placed in patients using either a dual-curing adhesive or a self-adhesive luting material

1 day

1 visit (in-person)

Follow-up

Participants are monitored for post-operative sensitivity and quality of crowns

4 weeks

Weekly feedback

Long-term follow-up

Participants are assessed for quality criteria of crowns over time

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Lithium Disilicate Crowns

Trial Overview The study tests lithium disilicate crowns placed using two different adhesives: dual-curing adhesive or self-adhesive luting material combined with total etch/universal bonding agent. It aims to determine the best method for attaching these types of dental crowns.

How Is the Trial Designed?

Group I: Crowns self-adhesively cemented Experimental Treatment 1 Intervention

Group 1 receives crowns with an occlusal thickness of 1.5 mm and luted with a self-adhesive, self-curing resin cement (SpeedCem Plus, Ivoclar Vivadent AG).

Group II: Crowns adhesively luted Experimental Treatment 1 Intervention

Group 2 receives crowns with an occlusal thickness of 1.2 mm delivered with a dual-curing resin cement (Variolink Esthetic (DC),Ivoclar Vivadent AG).

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10373088/

Clinical outcomes of single full-coverage lithium disilicate ... This systematic review aimed to investigate the clinical outcomes of LDC full-coverage crowns (FCC) in permanent teeth compared with those of other full- ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10872741/

Minimally invasive CAD/CAM lithium disilicate partial ... Therefore, the aim of this in-vitro study was to evaluate the fatigue survival and failure load of CAD/CAM fabricated LDS standard (1.5 mm), ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05070416

NCT05070416 | Lithium Disilicate Crowns Study Group 1 receives crowns with an occlusal thickness of 1.5 mm and luted with a self-adhesive, self-curing resin cement (SpeedCem Plus, Ivoclar Vivadent AG).

4. researchgate.net researchgate.net/publication/370966235_Clinical_Outcomes_of_Single_Full-Coverage_Lithium_Disilicate_Restorations_A_Systematic_Review

(PDF) Clinical Outcomes of Single Full-Coverage Lithium ... This systematic review aimed to investigate the clinical outcomes of LDC full-coverage crowns (FCC) in permanent teeth compared with those of ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0300571225004488

Clinical outcomes and complications of tooth- and implant ... Clinical outcomes of lithium disilicate single crowns and partial fixed dental prostheses: a systematic review. [Review]. J. Prosthetic Dentistry, 112 (2014) ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12528514/

Post fatigue fracture resistance of lithium disilicate and ... while lithium-disilicate crowns showed lower fracture values (Group A1: 1880 N, Group A2: 1512 N). One-way ANOVA test revealed statistically ...

7. mdpi.com mdpi.com/2227-9067/12/8/1019

Long-Term Performance of Feldspathic and Lithium ... All failures occurred in the feldspathic veneer group, while lithium disilicate crowns exhibited a 100% success rate (Fisher's Exact Test, p < 0.001), as seen ...

8. ivoclar.com ivoclar.com/en_us/products/cementation/variolink-esthetic

Variolink Esthetic | Adhesive Cementation Variolink Esthetic is a light- and dual-cure luting composite, which is used for the adhesive cementation of dental restorations.

9. researchgate.net researchgate.net/publication/26289479_Clinical_outcome_of_three-unit_lithium-disilicate_glass-ceramic_fixed_dental_prostheses_Up_to_8_years_results

(PDF) Clinical outcome of three-unit lithium-disilicate glass ... The purpose of this prospective study was to evaluate the clinical outcome of crown-retained fixed dental prostheses (FDPs) made from a lithium- ...