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Celtra Duo Computer Assisted Design/Computer Assisted Machining (CAD/CAM) Dental Crown Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03036579
Recruitment Status : Suspended (Intervention/interactions are temporarily paused due to COVID-19 and are expected to resume. This is not a suspension of IRB approval)
First Posted : January 30, 2017
Last Update Posted : April 14, 2020
Dentsply International
Information provided by (Responsible Party):
Dennis J. Fasbinder, DDS, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Fractured Tooth Decayed Tooth Unsatisfactory Restoration of Tooth Device: Celtra Duo Not Applicable

Detailed Description:
The study will be composed of two groups of 50 crowns placed in adult patients that have been identified as requiring at least one crown on a posterior tooth. A maximum of two crowns per patient will be completed. All the crowns will be made from the same high strength ceramic material (Celtra Duo/Dentsply Sirona). The two groups of crowns will be made using two different processes to create the surface texture and finish for the crown. One group of Celtra Duo crowns (Group 1) will be glaze-fired in a porcelain oven and the second group (Group 2) will be hand-polished. All the crowns will be cemented using two adhesive techniques. All of the oven-fired, glazed crowns will be cemented using the self-etching, self-adhesive resin cement technique (Calibra Universal Cement/Dentsply). All of the hand polished crowns will be cemented using an adhesive bonding technique using Prime & Bond Elect (Dentsply) with a dual cured resin cement (Calibra Ceram/Dentsply). The crowns are planned to be evaluated at 6 months, 1 year, 2 years, 3 years, and if funding permits, 4 years, and 5 years. At each appointment an examination of the crown will be completed as well as clinical photographs, an intraoral digital scan, and impression of the crown.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Masking Description: Final surface fabrication was not identified in the treatment process until the crown was milled.
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Chairside Computer Assisted Design/Computer Assisted Machining (CAD/CAM) Zirconia-reinforced Lithium Silicate Ceramic Crowns
Study Start Date : November 2015
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : October 2024

Arm Intervention/treatment
Experimental: Glazed Fired, Calibra Céram
Celtra Duo crowns will be glaze-fired in a porcelain oven and cemented with Calibra Ceram Cement
Device: Celtra Duo
Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.

Experimental: Hand Polished, Calibra Universal
Celtra Duo crowns will be hand-polished and cemented with Calibra Universal Cement
Device: Celtra Duo
Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.

Primary Outcome Measures :
  1. Crown failure [ Time Frame: from delivery of the crown up to 5 years ]
    Crown failure includes fracture of the crown or loss of the crown requiring placement of a new crown at any time between delivery and five years.

Secondary Outcome Measures :
  1. Crown loss of retention [ Time Frame: from delivery of the crown up to 5 years ]
    Loss of retention is measured as detachment of the crown from the tooth without fracture of the crown requiring recementation of the crown.

  2. Tooth sensitivity [ Time Frame: from delivery of the crown up to 5 years ]
    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.

  3. Margin staining [ Time Frame: from delivery of the crown up to 5 years ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03036579

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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Dentsply International
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Principal Investigator: Dennis J Fasbinder, DDS University of Michigan
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Responsible Party: Dennis J. Fasbinder, DDS, Clinical Professor, University of Michigan Identifier: NCT03036579    
Other Study ID Numbers: HUM00103921
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: April 14, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Dennis J. Fasbinder, DDS, University of Michigan:
Additional relevant MeSH terms:
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Dental Caries
Tooth Fractures
Wounds and Injuries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Tooth Injuries