Back to resultsPosterior CAD/CAM Cobalt-chromium Alloy Single Crowns: 4-year Prospective Clinical Study
Primary Purpose
Single Tooth Lost
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Co-Cr single crown
Periodontal parameters
Sponsored by
About this trial
This is an interventional treatment trial for Single Tooth Lost
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Co-Cr single crown
Contralateral sound tooth
Arm Description
Co-Cr single crown
Contralateral sound tooth
Outcomes
Primary Outcome Measures
Survival percentage
Kaplan Meier analysis of survival of the prostheses
Secondary Outcome Measures
Full Information
NCT ID
NCT02956174
First Posted
October 30, 2016
Last Updated
November 5, 2016
Sponsor
Federico II University
1. Study Identification
Unique Protocol Identification Number
NCT02956174
Brief Title
Posterior CAD/CAM Cobalt-chromium Alloy Single Crowns: 4-year Prospective Clinical Study
Official Title
Posterior CAD/CAM Cobalt-chromium Alloy Single Crowns: 4-year Prospective Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Single Tooth Lost
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Co-Cr single crown
Arm Type
Experimental
Arm Description
Co-Cr single crown
Arm Title
Contralateral sound tooth
Arm Type
Active Comparator
Arm Description
Contralateral sound tooth
Intervention Type
Device
Intervention Name(s)
Co-Cr single crown
Intervention Type
Other
Intervention Name(s)
Periodontal parameters
Primary Outcome Measure Information:
Title
Survival percentage
Description
Kaplan Meier analysis of survival of the prostheses
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Learn more about this trial
Posterior CAD/CAM Cobalt-chromium Alloy Single Crowns: 4-year Prospective Clinical Study
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