TetricCAD Crown Clinical Study
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Dental |
| Therapuetic Areas: | Dental / Maxillofacial Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/25/2018 |
| Start Date: | October 1, 2018 |
| End Date: | October 2024 |
Clinical Evaluation of Chairside CAD/CAM Resilient Ceramic Crowns
This investigation will be a clinical trial to study the performance of a new resin-based
ceramic material for crowns. The material 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. The purpose of the study is to measure how
well the high strength crowns function over an extended period of time.
ceramic material for crowns. The material 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. 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 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 resilient ceramic CAD/CAM
block(Tetric CAD/Ivoclar Vivadent). The crowns are placed using an adhesive bonding process
including a total etch process with a universal adhesive (Adhese by Ivoclar Vivadent) and
dual-cured resin cement (Variolink Esthetic by Ivoclar Vivadent). 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.
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 resilient ceramic CAD/CAM
block(Tetric CAD/Ivoclar Vivadent). The crowns are placed using an adhesive bonding process
including a total etch process with a universal adhesive (Adhese by Ivoclar Vivadent) and
dual-cured resin cement (Variolink Esthetic by Ivoclar Vivadent). 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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