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

August 2, 2021 updated by: Mohamed Shawky, Cairo University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

• 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

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 60 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: immediate loading with all on four technique in FFF
immediately loaded dental implants with the all-on-four technique in free vascularized fibular grafts
Device: immediate loading with all on four technique in FFF
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Mohamed Shawky, MSc, Assistant lecturer. OMFS. Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 30, 2019

Primary Completion (ACTUAL)

April 30, 2021

Study Completion (ACTUAL)

May 20, 2021

Study Registration Dates

First Submitted

May 13, 2019

First Submitted That Met QC Criteria

May 13, 2019

First Posted (ACTUAL)

May 15, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 6, 2021

Last Update Submitted That Met QC Criteria

August 2, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • cairo omfs masters

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Reconstructed Jaws

Clinical Trials on immediate loading with all on four technique in FFF

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe