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

University of Michigan

Status

Terminated

Conditions

Fractured Tooth

Decayed Tooth

Unsatisfactory Restoration of Tooth

Treatments

Device: Celtra Duo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03036579

HUM00103921

Details and patient eligibility

About

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.

Full 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.

Enrollment

73 patients

Sex

All

Ages

18+ years old

Volunteers

No 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