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Evaluation of Soft Tissue Profile Changes Following Autogenous Fat or Onlay Polyetheretherketone (PEEK) Augmentation Versus Sliding Genioplasty for Correction of Deficient Chin

NCT03747822 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-11-23

No results posted yet for this study

Summary

Fat is a filler with ideal properties as it naturally integrates into tissues with 100 % biocompatibility. Moreover, fat contains different cell types, including adipocytes, fibroblasts, smooth muscle cells, endothelial cells, and adipogenic progenitor cells called"preadipocytes"2, adipose-derived stem cells (ASCs) which have a differentiation potential similar to that of other mesenchymal stem cells and it could be harvested in great amounts with minimal donor-site morbidity, ASCs have proved to be particularly promising for regenerative therapies. In addition, it's relatively inexpensive and readily available, which makes it an attractive alternative for facial augmentation.

On the other hand PEEK is considered a highly biocompatible material with mechanical properties almost similar to cortical bone. It is widely used in cranioplasties and facial reconstruction.

Conditions

  • Patients With Deficient Chin

Interventions

PROCEDURE

fat filler,PEEK,sliding genioplasty

The procedure will be done under general anesthesia; the donor site lower abdomen, flank, lateral thigh, or inner thigh will be infused using a solution that consisted of 100 ml of normal saline with 50 mg (0.05%) of lidocaine and 0.1 ml of epinephrine. Liposuction will be performed using a 2-mm blunt cannula. A 20-cc syringe will be used to collect the fat. The fat will be injected into the chin in a supraperiosteal (subcutaneous) plane with a blunt 2-mm cannula using a fanning technique.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-02-28
Primary Completion
2020-02-29
Completion
2020-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03747822 on ClinicalTrials.gov