NCT04604314

Alternative EndoCrowns Designs for Chairside CAD/CAM

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years – 110 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endodontically Treated Teeth

Interventions

Type	Name	Description
DEVICE	CEREC Tessera	Full ceramic endocrown restorations will be made from the high strength ceramic, CEREC Tessera

Timeline

• Start date: 2020-12-10
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2020-10-27
• Last updated: 2025-07-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study