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

Not Applicable

Completed

• Conditions: Reconstructed Jaws; Free Fibula Flaps; All on Four Technique
• Interventions: Device: immediate loading with all on four technique in FFF

• Registration Number: NCT03950284
• Lead Sponsor: Cairo University

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.

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 Timeline

• Study First Submitted: 2019-05-13
• Study First Submitted QC: 2019-05-13
• Study First Posted: 2019-05-15
• Study Start: 2019-05-30
• Primary Completion: 2021-04-30
• Study Completion: 2021-05-20
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-02
• Last Update Posted: 2021-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
immediate loading with all on four technique in FFF	immediate loading with all on four technique in FFF	immediately loaded dental implants with the all-on-four technique in free vascularized fibular grafts

Primary Outcome Measures

Name	Time	Method
Primary Stability	6 months	The primary outcome is the implant stability determined by the insertion torque at the time of insertion using OSSTELL device

Trial Locations

Locations (1)

Faculty of Dentistry; 🇪🇬 Cairo, Egypt