Posterior CAD/CAM Cobalt-chromium Alloy Single Crowns: 4-... | NCT02956174

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

NCT02956174

Sponsor

Federico II University

Status

Completed

Last Update Posted

Nov 8, 2016Estimated

Enrollment

89Actual

Phase

Not Applicable

Conditions

Single Tooth Lost

Interventions

Co-Cr single crown
Periodontal parameters

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Jul 2016Actual

Completion Date

Not provided

First Submitted Date

Oct 30, 2016

First Submission Date that Met QC Criteria

Nov 4, 2016

First Posted Date

Nov 7, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 5, 2016

Last Update Posted Date

Nov 8, 2016Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

89Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Co-Cr single crown	Experimental	Co-Cr single crown	Device: Co-Cr single crown Other: Periodontal parameters
Contralateral sound tooth	Active Comparator	Contralateral sound tooth	Other: Periodontal parameters

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Co-Cr single crown	Device		Co-Cr single crown
Periodontal parameters

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

68 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided