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Celtra Quatro Crown Study

Primary Purpose

Fractured Tooth, Decayed Tooth, Unsatisfactory Restoration of Tooth

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Celtra Quatro
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fractured Tooth focused on measuring Crown, Ceramic, CAD/CAM

Eligibility Criteria

18 Years - 110 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • must have at least one carious lesion or defective restoration or fractured tooth in a molar or premolar
  • reason for restoration should extend more than one-half the intercuspal width of the tooth requiring a full crown restoration
  • Teeth to be vital and asymptomatic prior to treatment
  • No more than two restorations will be placed per patient. If a patient presents with more than two acceptable teeth for the study, molar teeth will be included prior to premolar teeth.

Exclusion Criteria:

  • Devital or sensitive teeth
  • Teeth with prior endodontic treatment of any kind
  • Teeth with a history of direct or indirect pulp capping procedures
  • Patients with significant untreated dental disease to include periodontitis and rampant caries
  • Pregnant or lactating women
  • Patients with a history of allergies to any of the materials to be used in the study
  • Patients unable to return for the recall appointments

Sites / Locations

  • School os Dentistry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Crown, 1.0mm thickness, Calcium Aluminate Ionomer Cement

Crown, 1.5mm thickness, Calcium Aluminate Ionomer Cement

Crown, 1.0mm thickness, dual cure resin cement

Crown, 1.5mm thickness, dual cure resin cement

Arm Description

occlusal thickness of 1.0 mm delivered with a conventional Calcium Aluminate Ionomer cement

occlusal thickness of 1.5 mm delivered with a conventional Calcium Aluminate Ionomer cement

occlusal thickness of 1.0 mm delivered with Prime and Bond elect Universal Bond in total etch mode with a dual cure resin cement

occlusal thickness of 1.5 mm delivered with Prime and Bond elect Universal Bond in total etch mode with a dual cure resin cement

Outcomes

Primary Outcome Measures

Crown 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.

Secondary Outcome Measures

Crown 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 at any time between delivery and five years.
Tooth sensitivity
Patient described sensitivity on a scale of 1 to 4, where 1 means absence of sensitivity (pain) and four means severe discomfort noted routinely with cold or pressure stimulation.
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.

Full Information

First Posted
October 22, 2020
Last Updated
September 6, 2023
Sponsor
University of Michigan
Collaborators
Dentsply Sirona Implants and Consumables
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1. Study Identification

Unique Protocol Identification Number
NCT04604301
Brief Title
Celtra Quatro Crown Study
Official Title
Clinical Evaluation of High Strength Zirconia-Reinforced Lithium Silicate Chairside CAD/CAM Crowns
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 24, 2020 (Actual)
Primary Completion Date
November 1, 2026 (Anticipated)
Study Completion Date
November 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Dentsply Sirona Implants and Consumables

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
This investigation will be a clinical trial to study the performance of a newly developed high strength ceramic material for crowns. The ceramic has been approved by the FDA for patient treatment. A computer technique will be used to fabricate the crowns in a single appointment without the need for a temporary crown or second appointment. Two adhesive resin cement techniques will be used to hold the crown to the tooth and they will be evaluated for creating sensitivity to the tooth. The purpose of the study is to measure how well the high strength crowns function over an extended period of time.
Detailed Description
A recently introduced high strength, zirconia-reinforced lithium silicate (ZLS) ceramic material for full contour CAD/CAM crowns is reported to offer a more translucent and esthetic high strength crown in a more efficient oven firing process. Celtra Quatro (Dentsply Sirona) is submitted to a high temperature matrix firing cycle in the SpeedFire oven (Dentsply Sirona) to achieve high strength in less than 5 minutes following milling. It has a reported flexural strength of 650 MPa compared to 450 MPa for lithium disilicate glass ceramic and > 900 MPa for 3mol% full contour zirconia. Most glass ceramic materials have a recommended material thickness of 1.5 mm to maximize the strength potential of the material. Occlusal reduction resulting in a crown thickness of 1.0 mm, equitable to the recommendation for full contour zirconia crowns, may be considered sufficient to maintain the desired high strength attained by the ZLS material. This would also result in a more conservative tooth preparation. Another potential advantage of high strength ZLS crowns to many clinicians is that they may be inherently strong enough to allow for conventional cementation. However, for less retentive preparations, it may also be possible to adhesively bond the crowns through the use of adhesive resin cements. It is the intent of this investigation to evaluate the clinical application and performance of the new high strength, zirconia-reinforced lithium silicate material (Celtra Quatro) for CAD/CAM-generated chair-side crown applications. Patients will be recruited to have 60 Celtra Quatro crowns prepared and delivered during a single dental appointment using a chairside CAD/CAM system (CEREC/Dentsply Sirona). The crowns will be recalled at 6 months and then yearly for 5 years to evaluate long-term outcomes of the crowns.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractured Tooth, Decayed Tooth, Unsatisfactory Restoration of Tooth
Keywords
Crown, Ceramic, CAD/CAM

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Masking Description
The final thickness of the restoration was not identified until before treatment started The final cement was not identified in the treatment process until the crown was milled.
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Crown, 1.0mm thickness, Calcium Aluminate Ionomer Cement
Arm Type
Experimental
Arm Description
occlusal thickness of 1.0 mm delivered with a conventional Calcium Aluminate Ionomer cement
Arm Title
Crown, 1.5mm thickness, Calcium Aluminate Ionomer Cement
Arm Type
Experimental
Arm Description
occlusal thickness of 1.5 mm delivered with a conventional Calcium Aluminate Ionomer cement
Arm Title
Crown, 1.0mm thickness, dual cure resin cement
Arm Type
Experimental
Arm Description
occlusal thickness of 1.0 mm delivered with Prime and Bond elect Universal Bond in total etch mode with a dual cure resin cement
Arm Title
Crown, 1.5mm thickness, dual cure resin cement
Arm Type
Experimental
Arm Description
occlusal thickness of 1.5 mm delivered with Prime and Bond elect Universal Bond in total etch mode with a dual cure resin cement
Intervention Type
Device
Intervention Name(s)
Celtra Quatro
Intervention Description
Full ceramic crowns will be made from the high strength ceramic, Celtra Quatro
Primary Outcome Measure Information:
Title
Crown failure
Description
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.
Time Frame
from delivery of the crown up to 5 years
Secondary Outcome Measure Information:
Title
Crown loss of retention
Description
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 at any time between delivery and five years.
Time Frame
from delivery of crown up to 5 years
Title
Tooth sensitivity
Description
Patient described sensitivity on a scale of 1 to 4, where 1 means absence of sensitivity (pain) and four means severe discomfort noted routinely with cold or pressure stimulation.
Time Frame
from delivery of crown up to 5 years
Title
Margin staining
Description
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.
Time Frame
from delivery of crown up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: must have at least one carious lesion or defective restoration or fractured tooth in a molar or premolar reason for restoration should extend more than one-half the intercuspal width of the tooth requiring a full crown restoration Teeth to be vital and asymptomatic prior to treatment No more than two restorations will be placed per patient. If a patient presents with more than two acceptable teeth for the study, molar teeth will be included prior to premolar teeth. Exclusion Criteria: Devital or sensitive teeth Teeth with prior endodontic treatment of any kind Teeth with a history of direct or indirect pulp capping procedures Patients with significant untreated dental disease to include periodontitis and rampant caries Pregnant or lactating women Patients with a history of allergies to any of the materials to be used in the study Patients unable to return for the recall appointments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Fasbinder, DDS
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
School os Dentistry
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Celtra Quatro Crown Study

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