Computer Assisted Implant Surgery and Immediate Loading

NCT ID: NCT01866696

Last Updated: 2013-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Edentulous Jaws

Keywords

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Computer assisted implant surgery, Immediate loading, CAD/CAM

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

oral implants

Intervention Type DEVICE

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

* Clinical examination
* Radiological examination
* Guided oral implants insertion
* Immediate Prosthetic loading
* Follow-up

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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Oral implants Nobel Replace Tapered Groovy; Nobel Biocare AB, Goteborg, Sweden

Eligibility Criteria

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Inclusion Criteria

-edentulous patients or patients with hopeless teeth in need to be restored with full arches prosthesis

Exclusion Criteria

* 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
Minimum Eligible Age

39 Years

Maximum Eligible Age

78 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università degli Studi di Sassari

OTHER

Sponsor Role lead

Responsible Party

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Guglielmo Campus

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Silvio M Meloni, DDS

Role: STUDY_DIRECTOR

Università degli Studi di Sassari

Locations

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University of Sassari

Sassari, SS, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 23983690 (View on PubMed)

Other Identifiers

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ID051313

Identifier Type: -

Identifier Source: org_study_id