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Completed

NCT Number: NCT04604314

Alternative EndoCrowns Designs for Chairside CAD/CAM

This investigation will be a longitudinal clinical trial to study the association of preparation design on the internal and marginal adaptation of the resulting restorations and the long-term clinical performance of chairside CAD/CAM endocrown restorations. Advanced lithium disilicate chairside CAD/CAM endocrowns (CEREC Tessera/Dentsply Sirona) will be adhesively bonded using a selective enamel etch technique with a universal adhesive (Prime and Bond Elect/Dentsply Sirona) and a dual cure resin adhesive cement (Calibra Ceram/Dentsply Sirona). All restorations will be followed over five years of clinical service.

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Key information

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School os Dentistry

Ann Arbor, Michigan, 48109, United States

About this study

Endodontically treated teeth commonly present with extensive tooth structure loss due to caries, trauma, prior restorative treatment, and the endodontic access. These structural deficiencies lead to an increase in cusp deflection, crown fractures, microleakage, and decreased sensory feedback during function which greatly increases the possibility of tooth fracture.As a result, endodontically treated teeth require a full cuspal coverage restoration to prevent microleakage, restore function, and provide cuspal protection against tooth fracture. The most common restoration for endodontically treated teeth is core build-up, with or without a post, and full coverage crown.

This process requires multiple appointments with many technical steps ultimately leading to more chair time, treatment cost, and potential iatrogenic damage to the tooth. An alternative treatment is the endocrown, which utilizes the internal walls of the pulp chamber for macroretention and incorporates the core and crown in a monolithic restoration. The restoration is fabricated utilizing chairside CAD/CAM technology and is adhesively bonded to the tooth with resin cement. The EndoCrown restoration is more conservative relative to tooth structure loss, less expensive, and requires less chair time to complete when compared to conventional treatment while having comparable clinical longevity in molar teeth.

This investigation will be a longitudinal clinical trial to study the association of preparation design on the internal and marginal adaptation of the resulting restorations and the long-term clinical performance of chairside CAD/CAM endocrown restorations. Advanced lithium disilicate chairside CAD/CAM endocrowns (CEREC Tessera/Dentsply Sirona) will be adhesively bonded using a selective enamel etch technique with a universal adhesive (Prime and Bond Elect/Dentsply Sirona) and a dual cure resin adhesive cement (Calibra Ceram/Dentsply Sirona). All restorations will be followed over five years of clinical service.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject in need of final restoration following molar endodontic therapy
  • Subject age 18 or above -

Exclusion criteria

  • Teeth with remaining symptoms following endodontic therapy
  • Teeth which have experienced endodontic complications to include treated perforations, internal or external resorption, or separated endodontic files.
  • Teeth with exposure of the root canal filling material to the oral environment for greater than two weeks
  • Teeth diagnosed with symptoms of incomplete tooth fracture
  • Teeth with no adjacent or opposing tooth
  • Teeth serving as an abutment for fixed or removable dental prostheses
  • Subjects with uncontrolled bruxism or parafunctional habits
  • Subject has known allergies to any product used in this study
  • Subject will not be available for the study duration of 5 years
  • Subjects with significant untreated dental disease to include periodontitis and rampant caries
  • Women who self-report that they are pregnant or lactating

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Treatment and study plan

CEREC Tessera

Device

Full ceramic endocrown restorations will be made from the high strength ceramic, CEREC Tessera

Primary outcomes

  1. Restoration Failure

    Time frame: from delivery of the crown up to 3 years

    Restoration failure is scored by visual loss of the crown from the tooth requiring replacement of the study crown with a new crown at any time between delivery and three years.

Secondary outcomes

  1. Restoration Loss of Retention

    Time frame: from delivery of crown up to 3 years

    Loss of retention is measured as visual detachment or dislodgment of the crown from the tooth without fracture of the crown requiring recementation of the crown.

  2. Margin Staining

    Time frame: from delivery of crown up to 3 years

    Margin Staining is evaluated as either "0" if there is NO staining at the crown margin where it meets the tooth, or "1" if there IS staining at the crown margin where it meets the tooth. The better outcome is to have NO margin staining. The number of teeth with margin staining are listed below.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Dentsply Sirona Implants and Consumables

Registry information

Official study title

Clinical Performance of Alternative Preparation Designs for Chairside CAD/CAM Fabricated Advanced Lithium Disilicate EndoCrowns

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Oct 27, 2020
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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