Aesthetic Evaluation of Different Abutment Materials for OsseoSpeed Implants

March 14, 2014 updated by: Prof. Marco Ferrari, University of Siena

Aesthetic Outcome of Osseospeed Implants With Three Different Abutment Materials. A Randomized Controlled Clinical Study

The objective of the study was to assess the aesthetic outcome of different abutments materials and shapes on dental implants .

A set of parameters, including assessments of the mucosa and periodontal tissue , soft tissue , radiographic evaluations and clinical photographs, was used to obtain a measure of the aesthetic of implant-prosthesis rehabilitations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Siena, Italy, 53100
        • Department of Dental Materials and Fixed Prosthodontics of the University of Siena, Policlinico Le Scotte

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • aged over 18 years
  • dental implant rehabilitation requested
  • at least 1 tooth missing in areas between 1.5-3.5 and 3.5-4.5
  • sufficient bone volume for implant placement ( length 10-15mm; diameter 2.5-4mm, bone quality between class I and III of Lekholm and Zarb).
  • informed consensus acceptance

Exclusion Criteria:

  • systemic pathologies that represent controindication to implantology
  • smoking (more than 10 cigarettes per day)
  • severe bruxism
  • untreated periodontitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: titanium 1
titanium abutment type 1
Behavioral: aesthetic outcome
Active Comparator: titanium 2
titanium abutment type 2
Behavioral: aesthetic outcome
Active Comparator: zirconia 1
zirconia abutment type 1
Behavioral: aesthetic outcome
Active Comparator: zirconia 2
zirconia abutment type 2
Behavioral: aesthetic outcome
Active Comparator: titanium nitrate
titanium nitrate abutment
Behavioral: aesthetic outcome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
aesthetic evaluation
Time Frame: 12 months
measure of how the implant-prosthesis restoration is able to comply with the color, shape and proportions imitating as much as possible natural dentition.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
implant survival rate
Time Frame: 12 months
Survival rate means the success rate of the dental implant and/or the restoration that is placed on top of the dental implant.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Siena

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

March 14, 2014

First Submitted That Met QC Criteria

March 14, 2014

First Posted (Estimate)

March 18, 2014

Study Record Updates

Last Update Posted (Estimate)

March 18, 2014

Last Update Submitted That Met QC Criteria

March 14, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ABTM001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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