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

NCT03036579 | Terminated Results FDA Device

• 1 other identifier: HUM00103921
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Fractured Tooth; Decayed Tooth; Unsatisfactory Restoration of Tooth

Keywords

CAD/CAM; Ceramic; Crown

Outcome Measures

Primary Outcomes (1)

• Crown Failure

  Crown failure includes fracture of the crown or loss of the crown requiring placement of a new crown at any time between delivery and three years.

  from delivery of the crown up to 3 years

Secondary Outcomes (3)

• Crown Loss of Retention

  3 years

• Tooth Sensitivity

  3 years

• Margin Staining

  from delivery of the crown up to 3 years

Study Arms (2)

Glazed Fired, Calibra Céram

EXPERIMENTAL

Celtra Duo crowns will be glaze-fired in a porcelain oven and cemented with Calibra Ceram Cement

Device: Celtra Duo

Hand Polished, Calibra Universal

EXPERIMENTAL

Celtra Duo crowns will be hand-polished and cemented with Calibra Universal Cement

Device: Celtra Duo

Interventions

Celtra Duo DEVICE

Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.

Glazed Fired, Calibra Céram; Hand Polished, Calibra Universal

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Dentsply Sirona Inc.: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Tooth Fractures

Condition Hierarchy (Ancestors)

Tooth Injuries; Tooth Diseases; Stomatognathic Diseases; Wounds and Injuries

Results Point of Contact

• Title: Dennis J. Fasbinder, DDS
• Organization: University of Michigan

djfas@umich.edu

7346474450

Study Officials

• Dennis J Fasbinder, DDS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Final surface fabrication was not identified in the treatment process until the crown was milled.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 26, 2017
• First Posted: January 30, 2017
• Study Start: November 1, 2015
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: April 13, 2023
• Results First Posted: April 13, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)