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

November 5, 2016 updated by: Fernando Zarone, Federico II University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Not Applicable

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.

Eligibility Criteria

Ages Eligible for Study

21 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival percentage
Time Frame: 4 years
Kaplan Meier analysis of survival of the prostheses
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federico II University

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 Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

October 30, 2016

First Submitted That Met QC Criteria

November 4, 2016

First Posted (Estimate)

November 6, 2016

Study Record Updates

Last Update Posted (Estimate)

November 8, 2016

Last Update Submitted That Met QC Criteria

November 5, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FZ_Co-Cr_2016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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