Alternative EndoCrowns Designs for Chairside CAD/CAM

NCT04604314 | Active Not Recruiting FDA Device

• 1 other identifier: HUM00172803
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Endodontically Treated Teeth

Keywords

Ceramic; Crown; Endocrown

Outcome Measures

Primary Outcomes (1)

• Restoration failure

  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 five years.

  from delivery of the crown up to 5 years

Secondary Outcomes (2)

• Restoration loss of retention

  from delivery of crown up to 5 years

• Margin staining

  from delivery of crown up to 5 years

Study Arms (2)

Endocrown Onlay Restoration

EXPERIMENTAL

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.

Device: CEREC Tessera

Endocrown Shoulder Restorations

EXPERIMENTAL

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.

Device: CEREC Tessera

Interventions

CEREC Tessera DEVICE

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

Endocrown Onlay Restoration; Endocrown Shoulder Restorations

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Dentsply Sirona Implants and Consumables: collaborator

Study Sites (1)

School os Dentistry

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Tooth, Nonvital

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Dennis Fasbinder, DDS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: October 27, 2020
• Study Start: December 10, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)