NCT03950284

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Typical duration 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2019

Completed
15 days until next milestone

Study Start

First participant enrolled

May 30, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2021

Completed
Last Updated

August 6, 2021

Status Verified

August 1, 2021

Enrollment Period

1.9 years

First QC Date

May 13, 2019

Last Update Submit

August 2, 2021

Conditions

Reconstructed JawsFree Fibula FlapsAll on Four Technique

Outcome Measures

Primary Outcomes (1)

  • Primary Stability

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

    6 months

Study Arms (1)

immediate loading with all on four technique in FFF

EXPERIMENTAL

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

Interventions

immediate loading with all on four technique in FFFDEVICE

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.

immediate loading with all on four technique in FFF

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients with reconstructed jaws with free fibula flaps in either or both jaws.
  • Age group : from 15 to 60 years old
  • No sex predilection

You may not qualify if:

  • Patients with systemic condition counteracting with the surgical procedure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Cairo, Egypt

Location

Study Officials

  • Mohamed Shawky, MSc

    Assistant lecturer. OMFS. Cairo University

    PRINCIPAL INVESTIGATOR

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
principal investigator

Study Record Dates

First Submitted

May 13, 2019

First Posted

May 15, 2019

Study Start

May 30, 2019

Primary Completion

April 30, 2021

Study Completion

May 20, 2021

Last Updated

August 6, 2021

Record last verified: 2021-08

Locations

EG(1)