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OpenTrials
Completed

NCT Number: NCT02956174

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

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.

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Key information

Conditions

Single Tooth Lost

Age range

21 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Co-Cr single crown

Device

Periodontal parameters

Other

Primary outcomes

  1. Survival percentage

    Time frame: 4 years

    Kaplan Meier analysis of survival of the prostheses

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Registry information

Important dates

Study start
2012
Primary completion
2016
First posted
Nov 7, 2016
Registry last updated
Nov 8, 2016

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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