Edentulous Jaws Clinical Trial
Official title:
Computer Assisted Implant Surgery and Immediate Loading With Full-arch Screw Retained Prosthesis
| Verified date | May 2013 |
| Source | Università degli Studi di Sassari |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Italy: Ministry of Health |
| Study type | Interventional |
Purpose: The aim of this study was to analyze the clinical and radiographic outcomes of 23
edentulous jaws treated with 3D software planning, guided surgery, immediate loading and
restored with Cad-Cam Zirconia and titanium full arch frameworks.
Material & methods: This study was designed as a prospective clinical trial. Twenty patients
have been consecutively rehabilitated with an immediately loaded implant supported fixed
full prosthesis. A total of 120 fixtures supporting 23 bridges (8 mandible, 15 maxilla) were
placed , 22 of which in fresh post extraction sockets. All the implants were inserted with
an insertion torque of 35/45 Ncm. 117 out of 120 implants were immediately loaded the other
3 were delayed loaded.
Outcome measures were implants survival, radiographic marginal bone-levels and bone
remodeling, soft tissue parameters and complications.
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | June 2012 |
| Est. primary completion date | June 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 39 Years to 78 Years |
| Eligibility |
Inclusion criteria were: -edentulous patients or patients with hopeless teeth in need to be restored with full arches prosthesis Exclusion criteria were: - presence of systemic diseases (i.e. haematologic disease, uncontrolled diabetes, serious coagulopathies and diseases of the immune system) - irradiation to the head or neck region within 12 months before surgery - presence severe bruxism or clenching habits - pregnancy - poor oral hygiene - poor motivation to return for scheduled follow-up visit |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Italy | University of Sassari | Sassari | SS |
| Lead Sponsor | Collaborator |
|---|---|
| Università degli Studi di Sassari |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | peri-implant mucosal response | 12-30 months | Yes | |
| Other | prosthetic success | 0-30 months | Yes | |
| Other | biological and prosthetic complication | 12-30 months | Yes | |
| Primary | implants survival | 0-30 months | Yes | |
| Secondary | peri-implant bone | marginal bone remodeling and marginal bone level | 12-30 months | Yes |