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OpenTrials
Completed

NCT Number: NCT01866696

Computer Assisted Implant Surgery and Immediate Loading

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.

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Key information

Conditions

Edentulous Jaws Jaw Diseases Jaw, Edentulous Mouth Diseases Mouth, Edentulous Musculoskeletal Diseases Stomatognathic Diseases Tooth Diseases

Age range

39 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Sassari

Sassari, SS, 07100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oral implants

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

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

Primary outcomes

  1. implants survival

    Time frame: 0-30 months

Secondary outcomes

  1. peri-implant bone

    Time frame: 12-30 months

    marginal bone remodeling and marginal bone level

Other outcomes

  1. peri-implant mucosal response

    Time frame: 12-30 months

  2. prosthetic success

    Time frame: 0-30 months

  3. biological and prosthetic complication

    Time frame: 12-30 months

Sponsors and collaborators

Lead sponsor

Università degli Studi di Sassari

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2011
Study completion
2012
First posted
May 31, 2013
Registry last updated
May 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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