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NCT Number: NCT06173167

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan School of Dentistry

Ann Arbor, Michigan, 48109-1078, United States

Location status: Recruiting

Location contact

Dennis J Fasbinder

CONTACT

[email protected]

734-647-4450

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Crowns self-adhesively luted

Device

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).

Crowns conventionally cemented

Device

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 outcomes

  1. Short-term Post-operative Sensitivity

    Time frame: 4 weeks

    assessed by patient's weekly feedback for 4 weeks after the treatment rating sensitivity from 1 "no sensitivity" to 4 "severe discomfort noted routinely with cold or pressure stimulation"

Secondary outcomes

  1. Quality Criteria (modified FDI criteria)

    Time frame: 1 year to 2 years

    assessed following the FDI criteria on a scale from 1 "very good" to 5 "unacceptable" (e.g. post-operative hypersensitivity, surface lustre, Staining, fracture of material, retension, occlusal contour and wear, and colour match of restorations)

Study contacts

Contact information is provided by the study sponsor or research team.

Dennis J. Fasbinder, DDS

CONTACT

[email protected]

(734) 647-4450

Sponsors and collaborators

Lead sponsor

Ivoclar Vivadent AG

Industry

Collaborators

  • University of Michigan

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2026
First posted
Dec 15, 2023
Registry last updated
Mar 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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