Clinical Evaluation of Full Contour Zirconia Chairside CAD/CAM Crowns
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.
Conditions:
🦠 Dental Disorders Hard Tissues of Teeth 🦠 Dental Diseases
🗓️ Study Start (Actual) 8 January 2024
🗓️ Primary Completion (Estimated) 31 December 2024
✅ Study Completion (Estimated) 31 December 2026
👥 Enrollment (Estimated) 70
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Ann Arbor, Michigan, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 7 December 2023
  • First Submitted that Met QC Criteria 7 December 2023
  • First Posted 15 December 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 27 March 2024
  • Last Update Posted 28 March 2024
  • Last Verified December 2023