Clinical trial NCT02315794: Aesthetic Outcomes of Single Tooth Implant Using Metal Ceramic Restorations With Either Zirconia or Titanium Abutments
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Thick Gingival Margin to Tooth Restoration
Keywords: aesthetic outcome
titanium abutment
zirconia abutment
Lead sponsor: University of Firenze and Siena, Napoli, Italy
Sponsor class: OTHER
First posted: 2014-12-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* systemic diseases

Primary outcomes:
measure: change from baseline in the anatomic form and surface characteristics of the peri implant mucosa
timeFrame: one month and one year after the placement of the definitive crowns
Secondary outcomes:
measure: change from baseline in crestal bone levels
timeFrame: one month and one year after placing the definitive crown
measure: change from baseline in interdental soft tissue position
timeFrame: one month and one year after the placement of the definitive crowns
measure: change from baseline in thickness of the peri implant mucosa
timeFrame: one month and one year after the placement of the definitive crowns
Other outcomes:
Locations:
city: Siena
country: Italy
facility: Siena University, Department of Periodontology, Policlinico Le Scotte Siena.
city: Siena
country: Italy
facility: Tuscan School of Dentistry
Study officials:
affiliation: tuscal school of dental medicine
name: nicola baldini, oral surgeon
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.