Computer Assisted Implant Surgery and Immediate Loading

May 28, 2013 updated by: Guglielmo Campus, Università degli Studi di Sassari

Computer Assisted Implant Surgery and Immediate Loading With Full-arch Screw Retained Prosthesis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

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
    • SS
      • Sassari, SS, Italy, 07100
        • University of Sassari

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

39 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: guided implant insertion and immediate loading
This work was designed as a prospective case series clinical study. Twenty patients have been consecutively rehabilitated with an immediately loaded oral implant supported fixed full prosthesis. A total of 120 oral implants (Nobel Replace Tapered Groovy; Nobel Biocare AB, Goteborg, Sweden) supporting 23 bridges (8 mandible, 15 maxilla) were placed , 22 of which in fresh post extraction sockets. 117 out of 120 oral implants were immediately loaded.
Device: oral implants

For all cases, the following surgical and prosthetic protocol was followed.:

  • Clinical examination
  • Radiological examination
  • Guided oral implants insertion
  • Immediate Prosthetic loading
  • Follow-up
Other Names:
  • Oral implants Nobel Replace Tapered Groovy; Nobel Biocare AB, Goteborg, Sweden

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
implants survival
Time Frame: 0-30 months
0-30 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
peri-implant bone
Time Frame: 12-30 months
marginal bone remodeling and marginal bone level
12-30 months

Other Outcome Measures

Outcome Measure
Time Frame
peri-implant mucosal response
Time Frame: 12-30 months
12-30 months
prosthetic success
Time Frame: 0-30 months
0-30 months
biological and prosthetic complication
Time Frame: 12-30 months
12-30 months

Collaborators and Investigators

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

Sponsor

Università degli Studi di Sassari

Investigators

  • Study Director: Silvio M Meloni, DDS, Università degli Studi di Sassari

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2006

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

May 13, 2013

First Submitted That Met QC Criteria

May 28, 2013

First Posted (Estimate)

May 31, 2013

Study Record Updates

Last Update Posted (Estimate)

May 31, 2013

Last Update Submitted That Met QC Criteria

May 28, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID051313

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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