Aesthetic Evaluation Clinical Trial
Official title:
Aesthetic Outcome of Osseospeed Implants With Three Different Abutment Materials. A Randomized Controlled Clinical Study
| Verified date | March 2014 |
| Source | University of Siena |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Italy: Ethics Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 90 |
| Est. completion date | January 2014 |
| Est. primary completion date | July 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Italy | Department of Dental Materials and Fixed Prosthodontics of the University of Siena, Policlinico Le Scotte | Siena |
| Lead Sponsor | Collaborator |
|---|---|
| University of Siena |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | aesthetic evaluation | 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 | No |
| Secondary | implant survival rate | 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 | No |