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

NCT ID: NCT02956174

Last Updated: 2016-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Single Tooth Lost

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Co-Cr single crown

Co-Cr single crown

Group Type EXPERIMENTAL

Co-Cr single crown

Intervention Type DEVICE

Periodontal parameters

Intervention Type OTHER

Contralateral sound tooth

Contralateral sound tooth

Group Type ACTIVE_COMPARATOR

Periodontal parameters

Intervention Type OTHER

Interventions

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Co-Cr single crown

Intervention Type DEVICE

Periodontal parameters

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federico II University

OTHER

Sponsor Role lead

Responsible Party

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Fernando Zarone

Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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FZ_Co-Cr_2016

Identifier Type: -

Identifier Source: org_study_id