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Clinical Trials/NCT06095843
NCT06095843
Completed
Not Applicable

"Bony Changes Around Dental Implant Placed in Free Vascularized Fibular Graft Versus Non-Vascularized Iliac Crest Graft in Mandibular Reconstruction"

Ain Shams University1 site in 1 country14 target enrollmentJanuary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Crestal Bone Loss
Sponsor
Ain Shams University
Enrollment
14
Locations
1
Primary Endpoint
stability of dental implants
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The goal of this clinical trial is to evaluate the bony changes around dental implants in non-vascularized iliac crest grafts and free vascularized fibular flap in mandibular reconstruction.

The main question it aims to answer are:

• evaluate the bony changes around dental implants and it's survival rate in both groups

Detailed Description

The current prospective study was conducted on 10 patients that were selected and admitted for early or delayed mandibular reconstructive surgery from the outpatient who were referred to the department of Oral and Maxillofacial Surgery Faculty of Dentisry, Ain Shams University in the period from January 2018 till June 2022. The patients in this study were divided into two groups. First group endured non-vascularized iliac crest grafting with delayed implant insertion while the second group endured vascularized fibular flap with delayed implant insertion. Implant placement was done six months after performing reconstructive surgery.At the second stage surgery, all succeeded implants were loaded with fixed implant supported prothesis. Follow- up was done 1 week, 2 weeks, 4 weeks, 8 weeks and 12 weeks postoperatively. Crestal bone stability was analyzed using CBCT radiographs along with the percentages of of the survived implants and ISQ values were measured using an ostell device.

Registry
clinicaltrials.gov
Start Date
January 1, 2019
End Date
October 30, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Maged Mohamed Mostafa

Assistant lecturer of oral and maxillofacial surgery

Ain Shams University

Eligibility Criteria

Inclusion Criteria

  • patients following traumatic injuries
  • gunshot injuries
  • tumor ablative surgeries
  • osteomylitis and osteonecrosis affecting the mandible

Exclusion Criteria

  • cardiovascular or pulmonary disease
  • vascular or bone disorder
  • previous fractures or surgeries related to the donor site

Outcomes

Primary Outcomes

stability of dental implants

Time Frame: 1 year

measuring primary and secondary stability (ISK)

bony changes around dental implants

Time Frame: 1 year

measuring crestal bone loss (mm)

survival rate of dental implants

Time Frame: 1 year

measuring survival rate of dental implants (%)

Study Sites (1)

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