Aesthetic Outcomes of Single Tooth Implant Using Metal Ceramic Restorations With Either Zirconia or Titanium Abutments

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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Aesthetic Outcomes of Single Tooth Implant-supported Restorations Using Metal Ceramic Restorations With Either Zirconia or Titanium Abutments: A Randomized Controlled Clinical Study

Conditions
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Thick Gingival Margin to Tooth Restoration

Intervention / Treatment
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* Device: SPI®ART
* Device: SPI®EASY


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: mono-edentulism condition in the aesthetic zone minimum of 2 mm of keratinized gingiva Exclusion Criteria: systemic diseases

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPI®ART<br>in test group after a three month healing period a zirconia abutment was connected to the implant to realize the prosthetic restoration | Device: SPI®ART<br>* implant prothetic restoration using a yttrium oxide stabilized zirconia abutment<br>|
| Active Comparator: SPI®EASY<br>in control group a three month healing period a titanium abutment was connected to the implant for the prosthetic restoration | Device: SPI®EASY<br>* implant prosthetic restoration using a commercially pure titanium grade 4 abutment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in the anatomic form and surface characteristics of the peri implant mucosa | 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). | one month and one year after the placement of the definitive crowns | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in crestal bone levels | 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 | one month and one year after placing the definitive crown | 
| change from baseline in interdental soft tissue position | position of interdental papilla measured by means of Papilla Index ( Jemt, 1997) | one month and one year after the placement of the definitive crowns | 
| change from baseline in thickness of the peri implant mucosa | the thickness was measured by placing a calibrated endodontic file 2mm apical to the mucosal margin | one month and one year after the placement of the definitive crowns | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aesthetic outcome, titanium abutment, zirconia abutment