Recruiting NCT06173167
Clinical Evaluation of Full Contour Zirconia Chairside CAD/CAM Crowns
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Crowns self-adhesively luted, Crowns conventionally cemented.
- Who it may be relevant to
- Registry conditions: Dental Disorders Hard Tissues of Teeth, Dental Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This investigation will be a randomized, prospective, longitudinal clinical trial to study the clinical performance of a new monolithic, zirconia material with shade, translucency and material graduation for chairside CAD/CAM crowns. The restorations will be luted either with a self-adhesive luting material or a conventional cement. The crowns will be evaluated for a period of two years.
Interventions
- Device Crowns self-adhesively luted
After cavity preparation, the zirconia chairside crown will be placed using SpeedCEM Plus. The excess will be light cured with Bluephase G4 in PreCure mode (950 mW/cm\^2). After removal of the excess, the luting material margins will be light-cured again for 20s (1200 mW/cm\^2). - Device Crowns conventionally cemented
After cavity preparation, the zirconia chairside crown will be placed using ZirCAD Cement. The excess cement will be removed in the gel phase, either following light curing (5 - 10 seconds per segment) or following self-curing (approximately 2 min after placement). The restoration will be held in position during final curing that is complete 4 min 30 s after placement.
Primary outcome measures
- Short-term Post-operative Sensitivity [Time frame: 4 weeks]
Secondary outcome measures (1)
- Quality Criteria (modified FDI criteria) [Time frame: 1 year to 2 years]
Eligibility criteria
Inclusion criteria
- at least 18 years of age
- at least one carious lesion, defective restoration, or fractured portion of the tooth to be restored on a maxillary or mandibular premolar or molar tooth - Each lesion, fracture, or defective restoration should exhibit sufficient size or loss of tooth structure requiring a full crown restoration.
- tooth should have at least one opposing tooth in occlusion and one adjacent tooth with an intact proximal contact
- No more than ten teeth that are endodontically treated may be included in the study, equally divided between the two groups of crowns. All remaining teeth in the study will test vital and be asymptomatic at the beginning of treatment.
- No more than two restorations will be placed per patient
Exclusion criteria
- Sensitive teeth
- Teeth with a history of direct or indirect pulp capping procedures
- Patients with significant untreated dental disease to include periodontitis and/or rampant caries
- Women who self-report that they are possibly pregnant, pregnant, or lactating, as elective dental treatment is not indicated at these times
- Patients with a self-reported history of allergies to the materials to be used in the study including composite resin cements or zirconia restorative materials
- Patients unable to return for the recall appointments
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Michigan School of Dentistry — Ann Arbor
Identifiers
NCT: NCT06173167 · OTCS11686932 · HUM00241710