N/A
N=41
TetricCAD Crown Clinical Study
Fractured Tooth · Decayed Tooth · Unsatisfactory Restoration of Tooth
Bottom Line
View on ClinicalTrials.gov: NCT03716817 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Crown Failure — 4 crowns
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Tetric CAD (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Crown Failure |
4 | — |
| SECONDARY Crown Loss of Retention |
2 | — |
| SECONDARY Tooth Sensitivity |
— | — |
| SECONDARY Margin Staining |
1 | — |
Summary
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.
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
Data sourced from ClinicalTrials.gov (NCT03716817). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.