Aesthetic Evaluation of Different Abutment Materials for OsseoSpeed Implants

• Sponsor: University of Siena (Other)
• Overall Status: Completed
• CT.gov ID: NCT02090647
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 5
• Duration (Months): 24
• Patients Per Site Per Month: 3.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Aesthetic Evaluation; Implant Survival Rate	Behavioral: aesthetic outcome	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Aesthetic Outcome of Osseospeed Implants With Three Different Abutment Materials. A Randomized Controlled Clinical Study
• Study Start Date: Jan 1, 2012
• Actual Primary Completion Date: Jul 1, 2013
• Actual Study Completion Date: Jan 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. aesthetic evaluation [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.

Secondary Outcome Measures

1. implant survival rate [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Dental Materials and Fixed Prosthodontics of the University of Siena, Policlinico Le Scotte	Siena		Italy	53100

Sponsors and Collaborators

• University of Siena

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prof. Marco Ferrari, Professor, University of Siena
• ClinicalTrials.gov Identifier: NCT02090647
• Other Study ID Numbers: ABTM001
• First Posted: Mar 18, 2014
• Last Update Posted: Mar 18, 2014
• Last Verified: Mar 1, 2014

• Keywords provided by Prof. Marco Ferrari, Professor, University of Siena: dental implant, aesthetic, implant abutment

Study Results

No Results Posted as of Mar 18, 2014