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OpenTrials
Completed

NCT Number: NCT03950284

Assessment of the Stability of Immediately Loaded All-on-four Dental Implants in FFF Used for Reconstruction of the Jaws

The use of free vascularized fibula flaps for bony reconstruction has proved its success as a substitution for the resected bone and in some instances, the surrounding soft tissues

The aim of this case series study is to evaluate the stability of the dental implants placed in free fibula flaps substituting a resected mandible and/or maxilla when they are immediately loaded with the All-On-Four technique along with the patient satisfaction.

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Key information

Conditions

Reconstructed Jaws All on Four Technique Free Fibula Flaps

Age range

15 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry

Cairo, Egypt

About this study

  • Preoperative phase :

Patients will be subjected to:

  • Case history including personal data, medical, surgical and family history.
  • Clinical examination
  • Radiographic examination using computed tomography (C.T) bony and soft tissue window.
  • Diagnostic studying casts.
  • Operative phase :

All cases will undergo surgery under local regional anesthesia. Injection of local anaesthesia (Articaine 4% and 1:100000 epinephrine) for regional infiltration. Sequential drilling then insertion of the dental implant fixtures and abutments on which the prefabricated temporary prosthesis will be fixed.

  • Postoperative care Proper postoperative instructions will be given to the patient such as strict oral hygiene measures and soft diet for 1 month, in addition to the postoperative medications including antibiotics (amoxicillin 1g capsules b.d.s ) and analgesics (diclofenac potassium 50mg as needed). Adherence to follow ups will be also instructed

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with reconstructed jaws with free fibula flaps in either or both jaws.
  • Age group : from 15 to 60 years old
  • No sex predilection
  • Patients with no contraindications to surgical intervention Exclusion Criteria
  • Patients with systemic condition counteracting with the surgical procedure.

Treatment and study plan

immediate loading with all on four technique in FFF

Device

All cases will undergo surgery under local regional anesthesia. Injection of local anaesthesia (Articaine 4% and 1:100000 epinephrine) for regional infiltration. Sequential drilling then insertion of the dental implant fixtures and abutments on which the prefabricated temporary prosthesis will be fixed.

Primary outcomes

  1. Primary Stability

    Time frame: 6 months

    The primary outcome is the implant stability determined by the insertion torque at the time of insertion using OSSTELL device

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Assessment of the Stability of Immediately Loaded Dental Implants With the All-on-four Technique in Free Vascularized Fibular Grafts Used for Reconstruction of the Jaws

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
May 15, 2019
Registry last updated
Aug 6, 2021

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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