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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06095843
Other study ID # 9D
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date October 30, 2022

Study information

Verified date October 2023
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date October 30, 2022
Est. primary completion date October 30, 2022
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Procedure:
placement of dental implants
placement of dental implants in mandibular reconstruction.

Locations

Country Name City State
Egypt Ain Shams University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary bony changes around dental implants measuring crestal bone loss (mm) 1 year
Primary survival rate of dental implants measuring survival rate of dental implants (%) 1 year
Primary stability of dental implants measuring primary and secondary stability (ISK) 1 year
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