Clinical trial NCT04604314: Alternative EndoCrowns Designs for Chairside CAD/CAM
Official title: Clinical Performance of Alternative Preparation Designs for Chairside CAD/CAM Fabricated Advanced Lithium Disilicate EndoCrowns
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Endodontically Treated Teeth
Keywords: Ceramic
Crown
Endocrown
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Dentsply Sirona Implants and Consumables
First posted: 2020-10-27
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Subject in need of final restoration following molar endodontic therapy
2. Subject age 18 or above -

Exclusion Criteria:

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

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Primary outcomes:
measure: Restoration failure
timeFrame: from delivery of the crown up to 5 years
Secondary outcomes:
measure: Restoration loss of retention
timeFrame: from delivery of crown up to 5 years
measure: Margin staining
timeFrame: from delivery of crown up to 5 years
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: School os Dentistry
state: Michigan
Study officials:
affiliation: University of Michigan
name: Dennis Fasbinder, DDS
role: PRINCIPAL_INVESTIGATOR
References: