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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Crestal Bone Loss, Survival Rate

Intervention / Treatment
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* Procedure: placement of dental implants


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: implants in free vascularized fibular flap<br>placement of dental implants in free fibular flaps after mandibular reconstruction | Procedure: placement of dental implants<br>* placement of dental implants in mandibular reconstruction.<br>|
| Active Comparator: implants in non-vascularized iliac crest grafts<br>placement of dental implants in non-vascularized iliac crest grafts after mandibular reconstruction | Procedure: placement of dental implants<br>* placement of dental implants in mandibular reconstruction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bony changes around dental implants | measuring crestal bone loss (mm) | 1 year | 
| survival rate of dental implants | measuring survival rate of dental implants (%) | 1 year | 
| stability of dental implants | measuring primary and secondary stability (ISK) | 1 year |