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

NCT02315794 | Completed Phase 2

• 1 other identifier: aostirct
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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

Conditions

Thick Gingival Margin to Tooth Restoration

Keywords

aesthetic outcome; titanium abutment; zirconia abutment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• change from baseline in crestal bone levels

  one month and one year after placing the definitive crown

• change from baseline in interdental soft tissue position

  one month and one year after the placement of the definitive crowns

• change from baseline in thickness of the peri implant mucosa

  one month and one year after the placement of the definitive crowns

Study Arms (2)

SPI®ART

EXPERIMENTAL

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

SPI®EASY

ACTIVE COMPARATOR

in control group a three month healing period a titanium abutment was connected to the implant for the prosthetic restoration

Device: SPI®EASY

Interventions

SPI®ART DEVICE

implant prothetic restoration using a yttrium oxide stabilized zirconia abutment

SPI®ART

SPI®EASY DEVICE

implant prosthetic restoration using a commercially pure titanium grade 4 abutment

SPI®EASY

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• systemic diseases

Sponsors & Collaborators

• University of Firenze and Siena, Napoli, Italy: lead

Study Sites (2)

Siena University, Department of Periodontology, Policlinico Le Scotte Siena.

Siena, Siena, 53100, Italy

Location

Tuscan School of Dentistry

Siena, Siena, 53100, Italy

Location

Related Publications (2)

• 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. doi: 10.1111/j.1600-0501.2005.01128.x.

  PMID: 16307570 BACKGROUND

• Ferrantino L, Carrillo de Albornoz A, Sanz M. Five-year outcomes of a randomized controlled clinical trial comparing single-tooth implant-supported restoration with either zirconia or titanium abutments. J Clin Periodontol. 2023 Jun;50(6):744-754. doi: 10.1111/jcpe.13787. Epub 2023 Feb 28.

  PMID: 36748305 DERIVED

Study Officials

• nicola baldini, oral surgeon

  tuscal school of dental medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: oral surgeon

Study Record Dates

• First Submitted: December 6, 2014
• First Posted: December 12, 2014
• Study Start: September 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: February 1, 2011
• Last Updated: December 12, 2014

Record last verified: 2014-12

Locations

IT (2)