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Posterior CAD/CAM Cobalt-chromium Alloy Single Crowns: 4-year Prospective Clinical Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02956174
Recruitment Status : Completed
First Posted : November 6, 2016
Last Update Posted : November 8, 2016
Information provided by (Responsible Party):
Fernando Zarone, Federico II University

Brief Summary:

Objectives - To evaluate the 4-year clinical outcomes of ceramic veneered Computer Aided Design/Computer Aided Manufacturing (CAD/CAM) Co-Cr single crowns supported by natural teeth in posterior regions.

Material and methods - Eighty-nine patients were provided with 120 ceramic veneered CAD/CAM Co-Cr single crowns replacing either premolars and molars. Specific inclusion criteria were needed and tooth preparations were standardized and performed by 2 expert prosthodontists. CAD/CAM Co-Cr frameworks were fabricated and veneered with ceramics. The restorations were cemented using a eugenol-free zinc oxide luting agent. The patients were recalled after 1, 6, 12, 24, 36 and 48 months. The survival and success of the restorations were evaluated. The technical and esthetic outcomes were examined using the United States Public Health Service criteria. The biologic outcomes were analyzed at abutment and contralateral teeth and descriptive statistics were performed.

Condition or disease Intervention/treatment Phase
Single Tooth Lost Device: Co-Cr single crown Other: Periodontal parameters Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Posterior CAD/CAM Cobalt-chromium Alloy Single Crowns: 4-year Prospective Clinical Study
Study Start Date : May 2012
Actual Primary Completion Date : July 2016

Arm Intervention/treatment
Experimental: Co-Cr single crown
Co-Cr single crown
Device: Co-Cr single crown
Other: Periodontal parameters
Active Comparator: Contralateral sound tooth
Contralateral sound tooth
Other: Periodontal parameters

Primary Outcome Measures :
  1. Survival percentage [ Time Frame: 4 years ]
    Kaplan Meier analysis of survival of the prostheses

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • good general health
  • American Society of Anesthesiologists (ASA) ASA I or ASA II condition; periodontal health
  • Angle class I occlusal relationship
  • minimum of 10 couples of opponent teeth
  • good oral hygiene
  • no evident signs of parafunctions and/or temporomandibular disorders.
  • periodontal health of abutment teeth (absence of tooth mobility, absence of furcation involvement);
  • proper positioning of abutment teeth in the dental arch (tooth axis adequate for a SC)
  • sufficient occlusal-cervical height of the clinical crown of abutment teeth (≥ 4 mm) for the retention of a SC
  • vital or endodontically treated to a clinically sound state abutment teeth;
  • abutment teeth opposing natural teeth.

Exclusion criteria:

  • high caries activity
  • presence of periodontal disease on the abutment tooth
  • occlusal-cervical height of the abutment tooth < 4 mm
  • reduced interocclusal distance or supraerupted opposing teeth
  • unfavorable crown-to-root ratio
  • severe were facets, clenching and/or bruxism
  • presence of removable partial dentures (RPDs)
  • pregnancy or lactation
  • alcohol and/or drug addiction
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Responsible Party: Fernando Zarone, Full Professor, Federico II University Identifier: NCT02956174    
Other Study ID Numbers: FZ_Co-Cr_2016
First Posted: November 6, 2016    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Tooth Loss
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases