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Trial record 39 of 119 for:    ZIRCONIUM

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

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ClinicalTrials.gov Identifier: NCT02315794
Recruitment Status : Completed
First Posted : December 12, 2014
Last Update Posted : December 12, 2014
Sponsor:
Information provided by (Responsible Party):
nicola baldini, University of Firenze and Siena, Napoli, Italy

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Thick Gingival Margin to Tooth Restoration Device: SPI®ART Device: SPI®EASY Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aesthetic Outcomes of Single Tooth Implant-supported Restorations Using Metal Ceramic Restorations With Either Zirconia or Titanium Abutments: A Randomized Controlled Clinical Study
Study Start Date : September 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Zirconium

Arm Intervention/treatment
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
Device: SPI®ART
implant prothetic restoration using a yttrium oxide stabilized zirconia abutment

Active Comparator: SPI®EASY
in control group a three month healing period a titanium abutment was connected to the implant for the prosthetic restoration
Device: SPI®EASY
implant prosthetic restoration using a commercially pure titanium grade 4 abutment




Primary Outcome Measures :
  1. 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 ]
    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).


Secondary Outcome Measures :
  1. 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

  2. change from baseline in interdental soft tissue position [ Time Frame: one month and one year after the placement of the definitive crowns ]
    position of interdental papilla measured by means of Papilla Index ( Jemt, 1997)

  3. change from baseline in thickness of the peri implant mucosa [ Time Frame: one month and one year after the placement of the definitive crowns ]
    the thickness was measured by placing a calibrated endodontic file 2mm apical to the mucosal margin



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • mono-edentulism condition in the aesthetic zone
  • minimum of 2 mm of keratinized gingiva

Exclusion Criteria:

  • systemic diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315794


Locations
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Italy
Siena University, Department of Periodontology, Policlinico Le Scotte Siena.
Siena, Italy, 53100
Tuscan School of Dentistry
Siena, Italy, 53100
Sponsors and Collaborators
University of Firenze and Siena, Napoli, Italy
Investigators
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Principal Investigator: nicola baldini, oral surgeon tuscal school of dental medicine

Publications:
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Responsible Party: nicola baldini, oral surgeon, University of Firenze and Siena, Napoli, Italy
ClinicalTrials.gov Identifier: NCT02315794     History of Changes
Other Study ID Numbers: aostirct
First Posted: December 12, 2014    Key Record Dates
Last Update Posted: December 12, 2014
Last Verified: December 2014
Keywords provided by nicola baldini, University of Firenze and Siena, Napoli, Italy:
aesthetic outcome
titanium abutment
zirconia abutment