Alternative EndoCrowns Designs for Chairside CAD/CAM

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Endodontically Treated Teeth
• Intervention / Treatment: Device: CEREC Tessera

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.

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • School os Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

    -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endocrown Onlay Restoration; 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; Full ceramic endocrown restorations will be made from the high strength ceramic, CEREC Tessera
Experimental: Endocrown Shoulder Restorations; 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; Full ceramic endocrown restorations will be made from the high strength ceramic, CEREC Tessera

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Restoration loss of retention	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.	from delivery of crown up to 5 years
Margin staining	Margin staining is categorized based on modified US Public Health Service criteria using a four point scale where 1 is no staining and 4 is penetrating stain involving more than 50% of the margin.	from delivery of crown up to 5 years

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Dentsply Sirona Implants and Consumables
• Investigators: Principal Investigator: Dennis Fasbinder, DDS, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: October 22, 2020
• First Submitted That Met QC Criteria: October 22, 2020
• First Posted (Actual): October 27, 2020

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Ceramic; Crown; Endocrown
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Tooth, Nonvital
• Other Study ID Numbers: HUM00172803

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No