Celtra Duo Computer Assisted Design/Computer Assisted Machining (CAD/CAM) Dental Crown Study
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Dental |
| Therapuetic Areas: | Dental / Maxillofacial Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/9/2019 |
| Start Date: | November 2015 |
| End Date: | October 2021 |
Clinical Evaluation of Chairside Computer Assisted Design/Computer Assisted Machining (CAD/CAM) Zirconia-reinforced Lithium Silicate Ceramic Crowns
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.
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.
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.
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.
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
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University of Michigan The University of Michigan was founded in 1817 as one of the...
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