What is the mechanism of action of this treatment?

Root canal treatment (RCT) involves the removal of infected or damaged pulp tissue from within a tooth, followed by cleaning, shaping, and filling the root canals to prevent further infection. Advanced restorative materials, such as lithium disilicate chairside CAD/CAM endocrowns, are used to restore the tooth's structure and function after RCT. These materials provide high strength and esthetics, ensuring the tooth can withstand biting forces and blend seamlessly with natural teeth. The use of such advanced materials is crucial for RCT patients as it enhances the long-term success of the treatment by providing durable and visually appealing restorations, reducing the risk of future fractures or failures.

What side effects are associated with this type of intervention?

Common side effects of root canal treatments include pain, swelling, and infection at the treatment site. When using advanced restorative materials like lithium disilicate chairside CAD/CAM endocrowns, patients may experience sensitivity to hot or cold, discomfort due to the fit of the crown, and potential allergic reactions to the materials used. However, these advanced materials are generally well-tolerated and provide high strength and esthetics, which can enhance the overall success and satisfaction of the treatment.

What prior FDA approvals exist?

The FDA has approved various materials and techniques for root canal treatments and dental restorations that emphasize high strength and esthetics. One notable example is the use of advanced lithium disilicate for chairside CAD/CAM endocrowns, which are known for their durability and aesthetic appeal. These materials are designed to be adhesively bonded using selective enamel etch techniques and dual-cure resin adhesive cements, providing a reliable and visually pleasing solution for dental restorations.

What other types of research exist?

Promising novel alternatives to advanced lithium disilicate chairside CAD/CAM endocrowns for root canal treatment patients in 2024 include zirconia-based materials, which offer high strength and durability, and hybrid ceramic materials like resin nanoceramics, which provide a balance of strength and esthetics. These materials are gaining popularity due to their improved performance and aesthetic qualities.

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CAD/CAM Device

CAD/CAM Endocrown for Nonvital Teeth

N/A

Waitlist Available

Led By Dennis Fasbinder, DDS

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject age 18 or above

Be older than 18 years old

Must not have

Subjects with significant untreated dental disease to include periodontitis and rampant caries

Teeth with remaining symptoms following endodontic therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from delivery of crown up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the description doesn't list specific side effects, typical risks may include sensitivity in the treated tooth, potential for chipping or breaking of the restoration material, discomfort during fitting process, and rare allergic reactions to materials used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I still have symptoms after my root canal treatment.

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

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My tooth's root canal filling has been exposed for over two weeks.

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I have a tooth diagnosed with a partial fracture.

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I am currently pregnant or breastfeeding.

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I have a tooth with no neighbors or opposite tooth.

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I use my teeth as support for dental bridges or dentures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from delivery of crown up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from delivery of crown up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from delivery of crown up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Restoration failure

Secondary study objectives

Margin staining

Restoration loss of retention

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Endocrown Shoulder RestorationsExperimental Treatment1 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 RestorationExperimental Treatment1 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.

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Root canal treatment (RCT) involves the removal of infected or damaged pulp tissue from within a tooth, followed by cleaning, shaping, and filling the root canals to prevent further infection. Advanced restorative materials, such as lithium disilicate chairside CAD/CAM endocrowns, are used to restore the tooth's structure and function after RCT. These materials provide high strength and esthetics, ensuring the tooth can withstand biting forces and blend seamlessly with natural teeth. The use of such advanced materials is crucial for RCT patients as it enhances the long-term success of the treatment by providing durable and visually appealing restorations, reducing the risk of future fractures or failures.

Current endodontic instruments, materials, and drugs, and new techniques for their application.Effect of Intracoronal Depth of Teeth Restored with Endocrowns on Fracture Resistance: In Vitro and 3-dimensional Finite Element Analysis.Phase format treatment for endodontic therapy.