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Computer Assisted Implant Surgery and Immediate Loading

Primary Purpose

Edentulous Jaws

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
oral implants
Sponsored by
Università degli Studi di Sassari
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Edentulous Jaws focused on measuring Computer assisted implant surgery,, Immediate loading,, CAD/CAM

Eligibility Criteria

39 Years - 78 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Sassari

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

guided implant insertion and immediate loading

Arm Description

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.

Outcomes

Primary Outcome Measures

implants survival

Secondary Outcome Measures

peri-implant bone
marginal bone remodeling and marginal bone level

Full Information

First Posted
May 13, 2013
Last Updated
May 28, 2013
Sponsor
Università degli Studi di Sassari
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1. Study Identification

Unique Protocol Identification Number
NCT01866696
Brief Title
Computer Assisted Implant Surgery and Immediate Loading
Official Title
Computer Assisted Implant Surgery and Immediate Loading With Full-arch Screw Retained Prosthesis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università degli Studi di Sassari

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous Jaws
Keywords
Computer assisted implant surgery,, Immediate loading,, CAD/CAM

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
guided implant insertion and immediate loading
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
oral implants
Other Intervention Name(s)
Oral implants Nobel Replace Tapered Groovy; Nobel Biocare AB, Goteborg, Sweden
Intervention Description
For all cases, the following surgical and prosthetic protocol was followed.: Clinical examination Radiological examination Guided oral implants insertion Immediate Prosthetic loading Follow-up
Primary Outcome Measure Information:
Title
implants survival
Time Frame
0-30 months
Secondary Outcome Measure Information:
Title
peri-implant bone
Description
marginal bone remodeling and marginal bone level
Time Frame
12-30 months
Other Pre-specified Outcome Measures:
Title
peri-implant mucosal response
Time Frame
12-30 months
Title
prosthetic success
Time Frame
0-30 months
Title
biological and prosthetic complication
Time Frame
12-30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
39 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvio M Meloni, DDS
Organizational Affiliation
Università degli Studi di Sassari
Official's Role
Study Director
Facility Information:
Facility Name
University of Sassari
City
Sassari
State/Province
SS
ZIP/Postal Code
07100
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
23983690
Citation
Meloni SM, De Riu G, Pisano M, Lolli FM, Deledda A, Campus G, Tullio A. Implant Restoration of Edentulous Jaws with 3D Software Planning, Guided Surgery, Immediate Loading, and CAD-CAM Full Arch Frameworks. Int J Dent. 2013;2013:683423. doi: 10.1155/2013/683423. Epub 2013 Jul 29.
Results Reference
derived

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Computer Assisted Implant Surgery and Immediate Loading

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