CAD/CAM Endocrown for Nonvital Teeth

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Bruxism, Allergies, Periodontitis, Pregnancy, others

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

Compensation: Varies

Number of Visits: 5

Duration: 1-2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new type of dental restoration called an endocrown, used for teeth that have undergone root canal treatment. Researchers aim to evaluate the fit and durability of these endocrowns over time, using advanced materials and techniques. The trial compares two endocrown designs, including one made with CEREC Tessera, to determine which performs best. Individuals who have completed root canal treatment on a molar and need a final tooth restoration may be suitable candidates. As an unphased trial, this study allows participants to contribute to innovative dental restoration research.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this CAD/CAM endocrown technique is safe for nonvital teeth?

Research shows that CAD/CAM ceramic endocrowns, such as CEREC Tessera, are highly reliable. Studies indicate these dental restorations have about a 90% success rate over two years and 93% over five years, making them a safe choice for repairing teeth.

For both onlay and shoulder restorations, no major safety concerns have been identified. Although some fractures have been reported, they remain rare. Overall, patients tolerate this treatment well.

The material used, advanced lithium disilicate, is known for its strength. It is up to 32% stronger than some other dental materials, enhancing its safety and durability in dental repairs.

In summary, CEREC Tessera endocrowns are generally considered safe and effective, with strong support from previous studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about CEREC Tessera for treating nonvital teeth because it offers a unique approach with its CAD/CAM Endocrown technique. Unlike traditional crowns that often require more extensive tooth preparation, the Endocrown Onlay Restoration preserves more of the tooth structure by keeping the buccal and lingual walls intact. This method maintains the tooth's integrity with minimal removal, which can lead to better long-term outcomes. Additionally, the Endocrown Shoulder Restorations provide a solution for teeth that have been previously restored, adapting to situations where the original crown height is compromised. These techniques are promising because they potentially offer a more conservative and adaptable option for restoring nonvital teeth.

What evidence suggests that CAD/CAM endocrowns are effective for nonvital teeth?

This trial will compare two types of CEREC Tessera endocrown restorations: Endocrown Onlay Restoration and Endocrown Shoulder Restorations. Studies have shown that CEREC Tessera endocrowns are strong and reliable. Research indicates that these dental restorations last a long time, with 90% lasting over two years and 93% lasting over five years for nonvital teeth. CEREC Tessera materials are up to 32% stronger than other similar materials, which helps prevent breakage. Previous studies also show that these endocrowns fit better on the tooth, with smaller gaps, ensuring a snug fit. Overall, the evidence supports CEREC Tessera endocrowns as a durable and effective option for restoring nonvital teeth. ^{4 6 7 8 9}

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 adults over 18 needing a final tooth restoration after molar root canal therapy. It's not for those with uncontrolled teeth grinding, pregnant or lactating women, people who can't commit to a 5-year study, or have certain dental conditions like untreated disease, symptoms of tooth fracture, or complications from previous root treatments.

Inclusion Criteria

I need a final dental restoration after root canal treatment on a molar.

Exclusion Criteria

I have significant untreated dental issues like gum disease or severe cavities.

I still have symptoms after my root canal treatment.

I have had root canal complications like perforations or file separations.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive endocrown restorations using chairside CAD/CAM technology, which are adhesively bonded to the tooth

1-2 weeks

Multiple visits for preparation and bonding

Follow-up

Participants are monitored for restoration failure, margin staining, and loss of retention over five years

5 years

Regular follow-up visits over 5 years

What Are the Treatments Tested in This Trial?

Interventions

• CEREC Tessera

Trial Overview The trial tests how different designs affect the fit and long-term success of CAD/CAM endocrown restorations made chairside using CEREC Tessera. These ceramic restorations are bonded with specific adhesives and cement and monitored over five years.

How Is the Trial Designed?

Group I: Endocrown Shoulder Restorations Experimental Treatment 1 Intervention

Endocrown shoulder preparation = Buccal and/or lingual walls are less than half the original occlusal-gingival height of the tooth or the buccal or lingual surfaces were previously prepared axially due to a prior restoration.

Group II: Endocrown Onlay Restoration Experimental Treatment 1 Intervention

Endocrown onlay preparation = Buccal and lingual walls are intact with an occlusal-gingival height at least equal to half the original crown height of the tooth. Remaining buccal and lingual walls maintain a thickness ≥ 2.0 mm.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Dentsply Sirona Implants and Consumables

Industry Sponsor

Trials

68

Recruited

4,800+

Simon Campion

Dentsply Sirona Implants and Consumables

Chief Executive Officer since 2022

PhD in Chemistry from Texas A&M University

Dr. Patrizia Cavazzoni

Dentsply Sirona Implants and Consumables

Chief Medical Officer

MD from Harvard Medical School

Dentsply Sirona Implants

Industry Sponsor

Trials

63

Recruited

4,600+

Simon Campion

Dentsply Sirona Implants

Chief Executive Officer since 2022

PhD in Chemistry from Texas A&M University

Dr. David Ferguson

Dentsply Sirona Implants

Chief Medical Officer

MD from Harvard Medical School

Citations

1. mdpi.com mdpi.com/2673-1592/6/5/80

Cervical Margin Relocation: Effect of Crown, Endocrown ... The mean fracture resistance values ranged between 2136.57 and 950.47 N. Significantly higher values were detected among Celtra Press than Cerec ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11725217/

Fit accuracy and fracture resistance evaluation of ... CEREC Tessera, a newly developed CAD/CAM block, delivers exceptional aesthetics, offers up to 32% greater strength compared to other glass ...

3. mdpi.com mdpi.com/2571-6131/8/2/33

Evaluation of Internal Adaptation of Different CAD/CAM ... This study demonstrates that all tested CAD/CAM endocrown materials exhibited clinically acceptable internal gaps, reinforcing their reliability and suitability ...

4. researchgate.net researchgate.net/publication/383845605_Cervical_Margin_Relocation_Effect_of_Crown_Endocrown_and_Onlay_Margin_Location_and_Material_Type_on_the_Fracture_Resistance_of_Endodontically_Treated_Molars

Cervical Margin Relocation: Effect of Crown, Endocrown ... The mean fracture resistance values ranged between 2136.57 and 950.47 N. Significantly higher values were detected among Celtra Press than Cerec ...

5. researchgate.net researchgate.net/publication/264867627_Evaluation_of_Cerec_endocrowns_a_preliminary_cohort_study

Evaluation of Cerec endocrowns: a preliminary cohort study At the three-year point, one molar crown fractured for a 1.3 percent failure rate. The resin cementation technique that was employed exhibited a ...

6. dentsplysirona.com dentsplysirona.com/en-us/discover/discover-by-brand/cerec-tessera.html

CEREC Tessera: CAD/CAM Blocks High-strength glass ceramic block · Tooth-like esthetics · Fast total processing time · Broad Case Indications · Instructions for use, safety data sheets, eMDR ...

7. dentsplysirona.com dentsplysirona.com/en-us/discover/discover-by-topic/resources/ds-dental-cements-guide/inlay-onlay.html

Inlay Onlay Cement Guide CEREC Tessera™ - Advanced Lithium Disilicate CAD/CAM blocks provide ... Instructions for use, safety data sheets, eMDR documents and more. Go to ...

8. withpower.com withpower.com/trial/phase-tooth-nonvital-11-2020-611e6

CAD/CAM Endocrown for Nonvital Teeth Research shows that CAD/CAM ceramic endocrowns, similar to CEREC Tessera, have high survival rates of 90% over two years and 93% over five years for restoring ...

9. hdtdental.cz hdtdental.cz/user/related_files/bro__ura-cerec-tessera-en.pdf?srsltid=AfmBOoro38xfR4ndyGFFBmpsPmNMOJ4POxJSVe47NWyYCsdp0Fw5YZkt

CEREC Tessera™ Data on file. CEREC Tessera™ CAD/CAM blocks provide outstanding esthetics for a truly tooth-like restoration. Up to 32% higher biaxial strength for restoration.