NCT01866696

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 31, 2013

Completed
Last Updated

May 31, 2013

Status Verified

May 1, 2013

Enrollment Period

5.2 years

First QC Date

May 13, 2013

Last Update Submit

May 28, 2013

Conditions

Edentulous Jaws

Keywords

Computer assisted implant surgery,Immediate loading,CAD/CAM

Outcome Measures

Primary Outcomes (1)

  • implants survival

    0-30 months

Secondary Outcomes (1)

  • peri-implant bone

    12-30 months

Other Outcomes (3)

  • peri-implant mucosal response

    12-30 months

  • prosthetic success

    0-30 months

  • biological and prosthetic complication

    12-30 months

Study Arms (1)

guided implant insertion and immediate loading

EXPERIMENTAL

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

Interventions

oral implantsDEVICE

For all cases, the following surgical and prosthetic protocol was followed.: * Clinical examination * Radiological examination * Guided oral implants insertion * Immediate Prosthetic loading * Follow-up

Also known as: Oral implants Nobel Replace Tapered Groovy; Nobel Biocare AB, Goteborg, Sweden
guided implant insertion and immediate loading

Eligibility Criteria

Age39 Years - 78 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sassari

Sassari, SS, 07100, Italy

Location

Related Publications (1)

  • 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.

    PMID: 23983690DERIVED

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth Diseases

Study Officials

  • Silvio M Meloni, DDS

    Università degli Studi di Sassari

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

May 13, 2013

First Posted

May 31, 2013

Study Start

April 1, 2006

Primary Completion

June 1, 2011

Study Completion

June 1, 2012

Last Updated

May 31, 2013

Record last verified: 2013-05

Locations

IT(1)