RECRUITING

Clinical Evaluation of Full Contour Zirconia Chairside CAD/CAM Crowns

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Conditions

Dental Disorders Hard Tissues of TeethDental DiseasesDental Caries, Caries

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Clinical Evaluation of Full Contour Zirconia Chairside CAD/CAM Crowns

Quick Facts

Study Start:2024-01-08
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06173167

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * at least 18 years of age
  2. * 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.
  3. * tooth should have at least one opposing tooth in occlusion and one adjacent tooth with an intact proximal contact
  4. * 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.
  5. * No more than two restorations will be placed per patient
  1. * Sensitive teeth
  2. * Teeth with a history of direct or indirect pulp capping procedures
  3. * Patients with significant untreated dental disease to include periodontitis and/or rampant caries
  4. * Women who self-report that they are possibly pregnant, pregnant, or lactating, as elective dental treatment is not indicated at these times
  5. * 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
  6. * Patients unable to return for the recall appointments

Contacts and Locations

Study Contact

Dennis J. Fasbinder, DDS
CONTACT
(734) 647-4450
djfas@umich.edu

Principal Investigator

Dennis J. Fasbinder, DDS
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

University of Michigan School of Dentistry
Ann Arbor, Michigan, 48109-1078
United States

Collaborators and Investigators

Sponsor: Ivoclar Vivadent AG

  • Dennis J. Fasbinder, DDS, PRINCIPAL_INVESTIGATOR, University of Michigan

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

Study Start Date2024-01-08
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-01-08
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • Dental Caries, Caries

Additional Relevant MeSH Terms

  • Dental Disorders Hard Tissues of Teeth
  • Dental Diseases