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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02315794
Other study ID # aostirct
Secondary ID
Status Completed
Phase Phase 2
First received December 6, 2014
Last updated December 9, 2014
Start date September 2009
Est. completion date February 2011

Study information

Verified date December 2014
Source University of Firenze and Siena, Napoli, Italy
Contact n/a
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date February 2011
Est. primary completion date January 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- mono-edentulism condition in the aesthetic zone

- minimum of 2 mm of keratinized gingiva

Exclusion Criteria:

- systemic diseases

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Thick Gingival Margin to Tooth Restoration

Intervention

Device:
SPI®ART
implant prothetic restoration using a yttrium oxide stabilized zirconia abutment
SPI®EASY
implant prosthetic restoration using a commercially pure titanium grade 4 abutment

Locations

Country Name City State
Italy Siena University, Department of Periodontology, Policlinico Le Scotte Siena. Siena
Italy Tuscan School of Dentistry Siena

Sponsors (1)

Lead Sponsor Collaborator
University of Firenze and Siena, Napoli, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Meijer HJ, Stellingsma K, Meijndert L, Raghoebar GM. A new index for rating aesthetics of implant-supported single crowns and adjacent soft tissues--the Implant Crown Aesthetic Index. Clin Oral Implants Res. 2005 Dec;16(6):645-9. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No