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

NCT ID: NCT03036579

Last Updated: 2023-04-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2019-09-30

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

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.

Conditions

Fractured Tooth; Decayed Tooth; Unsatisfactory Restoration of Tooth

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Glazed Fired, Calibra Céram

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

Group Type: EXPERIMENTAL

Celtra Duo

Intervention Type: DEVICE

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

Hand Polished, Calibra Universal

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

Group Type: EXPERIMENTAL

Celtra Duo

Intervention Type: DEVICE

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

Interventions

Celtra Duo

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dentsply Sirona Inc.

INDUSTRY

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Dennis J. Fasbinder, DDS

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dennis J Fasbinder, DDS

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HUM00103921

Identifier Type: -

Identifier Source: org_study_id