Aesthetic Outcomes of Single Tooth Implant Using Metal Ceramic Restorations With Either Zirconia or Titanium Abutments
December 9, 2014 updated by: nicola baldini, University of Firenze and Siena, Napoli, Italy
Aesthetic Outcomes of Single Tooth Implant-supported Restorations Using Metal Ceramic Restorations With Either Zirconia or Titanium Abutments: A Randomized Controlled Clinical Study
Different studies have proposed the use of zirconia abutments to improve the aesthetic outcomes in the anterior sextant, however the results have been inconclusive.
A tendency towards a better aesthetic result with the use of zirconia instead of titanium abutments was observed, although more technical complications were also recorded.The use of zirconia abutments in the anterior maxillary region showed a tendency towards better matching, although differences were not significant.
In addition, with these abutments more technical complications were observed, what increased the cost and time.
More studies with larger samples and longer observations periods are needed to recommend the use of zirconia abutments for this clinical situation
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of the present study was to evaluate the clinical and aesthetic outcomes of single tooth implant restorations, where different abutment materials were used (zirconia vs titanium) associated with metal-ceramic crowns.
The evaluation was carried out by means of an aesthetic composite index combined with patient evaluation
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Siena, Italy, 53100
- Siena University, Department of Periodontology, Policlinico Le Scotte Siena.
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Siena, Italy, 53100
- Tuscan School of Dentistry
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- mono-edentulism condition in the aesthetic zone
- minimum of 2 mm of keratinized gingiva
Exclusion Criteria:
- systemic diseases
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: SPI®ART
in test group after a three month healing period a zirconia abutment was connected to the implant to realize the prosthetic restoration
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implant prothetic restoration using a yttrium oxide stabilized zirconia abutment
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Active Comparator: SPI®EASY
in control group a three month healing period a titanium abutment was connected to the implant for the prosthetic restoration
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implant prosthetic restoration using a commercially pure titanium grade 4 abutment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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change from baseline in the anatomic form and surface characteristics of the peri implant mucosa
Time Frame: one month and one year after the placement of the definitive crowns
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the following parameters were assessed by means of standardized photographs: contour of the labial surface of the mucosa and its colour; when compared to the adjacent teeth , penalty points were assigned ( 0 = excellent; 1 or 2 = satisfactory; 3 or 4 = moderate; 5 ore more, poor).
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one month and one year after the placement of the definitive crowns
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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change from baseline in crestal bone levels
Time Frame: one month and one year after placing the definitive crown
|
in standardized intraoral radiographs the the following measurements were carried out : vertical distance from implant shoulder to the most coronal bone in contact with the implant at mesial and distal site; horizontal distance from the implant shoulder to the adjacent teeth at mesial and distal sites; vertical distance ( parallel to the implant long axis) from the contact point to the bone crest at mesial and distal sides
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one month and one year after placing the definitive crown
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change from baseline in interdental soft tissue position
Time Frame: one month and one year after the placement of the definitive crowns
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position of interdental papilla measured by means of Papilla Index ( Jemt, 1997)
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one month and one year after the placement of the definitive crowns
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change from baseline in thickness of the peri implant mucosa
Time Frame: one month and one year after the placement of the definitive crowns
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the thickness was measured by placing a calibrated endodontic file 2mm apical to the mucosal margin
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one month and one year after the placement of the definitive crowns
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: nicola baldini, oral surgeon, tuscal school of dental medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
September 1, 2009
Primary Completion (Actual)
January 1, 2010
Study Completion (Actual)
February 1, 2011
Study Registration Dates
First Submitted
December 6, 2014
First Submitted That Met QC Criteria
December 9, 2014
First Posted (Estimate)
December 12, 2014
Study Record Updates
Last Update Posted (Estimate)
December 12, 2014
Last Update Submitted That Met QC Criteria
December 9, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- aostirct
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