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

Not Applicable

Completed

• Conditions: Survival Rate; Crestal Bone Loss
• Interventions: Procedure: placement of dental implants

• Registration Number: NCT06095843
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study Start: 2019-01-01
• Primary Completion: 2022-10-30
• Study Completion: 2022-10-30
• Study First Submitted: 2022-11-08
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-17
• Last Update Submitted: 2023-10-21
• Study First Posted: 2023-10-23
• Last Update Posted: 2023-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
implants in free vascularized fibular flap	placement of dental implants	placement of dental implants in free fibular flaps after mandibular reconstruction
implants in non-vascularized iliac crest grafts	placement of dental implants	placement of dental implants in non-vascularized iliac crest grafts after mandibular reconstruction

Primary Outcome Measures

Name	Time	Method
stability of dental implants	1 year	measuring primary and secondary stability (ISK)
bony changes around dental implants	1 year	measuring crestal bone loss (mm)
survival rate of dental implants	1 year	measuring survival rate of dental implants (%)

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt