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

69 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies a new type of dental crown made from strong material, designed in the dentist's office, for patients with root canal-treated teeth. The crown uses the tooth's internal structure for support and is bonded with adhesive, making it less invasive and quicker to apply.

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 data supports the effectiveness of the treatment CEREC Tessera 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 nonvital teeth, indicating they are a reliable option for dental restoration. ^{1 2 3 4 5}

Is the CAD/CAM Endocrown treatment safe for humans?

The CAD/CAM Endocrown treatment, including versions like CEREC Tessera, has been studied for safety in humans. Clinical studies show a high survival rate of these crowns over several years, with some cases of fractures but no significant safety concerns reported. Overall, the treatment is considered reliable and safe for restoring nonvital teeth. ^{1 2 4 5 6}

How does the treatment CEREC Tessera differ from other treatments for nonvital teeth?

CEREC Tessera is unique because it uses advanced CAD/CAM technology to create endocrowns, which are custom-fitted crowns that extend into the tooth's pulp chamber, providing a strong and precise fit. This method offers a promising alternative to traditional crowns, with good aesthetic and functional results, and a high survival rate over several years. ^{1 2 3 6 7}

Research Team

Dennis Fasbinder, DDS

Principal Investigator

University of Michigan

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

References

1. England pubmed.ncbi.nlm.nih.gov

Cerec3D endocrowns--two-year clinical examination of CAD/CAM crowns for restoring endodontically treated molars. [2021]

2. China pubmed.ncbi.nlm.nih.gov

[A 5-year retrospective study of computer aided design and computer aided manufacturing ceramic endocrowns in endodontically treated posterior teeth]. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Impact of different CAD/CAM materials on internal and marginal adaptations and fracture resistance of endocrown restorations with: 3D finite element analysis. [2023]

4. China pubmed.ncbi.nlm.nih.gov

[An 8-year follow-up study of Cerec2 computer aided design and computer aided manufacture of all-ceramic crowns]. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Evaluation of Cerec endocrowns: a preliminary cohort study. [2019]

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

Fracture resistance and microleakage of endocrowns utilizing three CAD-CAM blocks. [2022]

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

Effect of different CAD-CAM materials on the marginal and internal adaptation of endocrown restorations: An in vitro study. [2020]