Clinical trial NCT03747822: Evaluation of Soft Tissue Profile Changes Following Autogenous Fat or Onlay Polyetheretherketone (PEEK) Augmentation Versus Sliding Genioplasty for Correction of Deficient Chin
Official title: Evaluation of Soft Tissue Profile Changes Following Autogenous Fat or Onlay Polyetheretherketone(PEEK) Augmentation Versus Sliding Genioplasty for Correction of Deficient Chin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Patients With Deficient Chin
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-11-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The chin is the most noticeable facial structure which plays an important role in perception of facial esthetics; therefore deficient chin is considered an annoying defect for the patient. Traditional techniques used for correction, which are osseous genioplasty and alloplastic augmentation, have some reported complications. These complications include hematoma in the floor of the mouth; though a rare complication is considered to be a life threatening condition. Also, wound dehiscence, infection, Chin hypoesthesia/dysesthesia due to mental nerve injury which occurs in 3.4% to 12% of cases , chin ptosis, lip ptosis, drooling, and an increase in lower teeth show due to failure to reattach the mentalis muscle to its natural origin on the anterior face of the mandibular body and tooth root damage which may occur during the osteotomy. Also bone resorption, implant displacement, infection and foreign body reaction were reported as a complication with some alloplastic implants .

This study aims to avoid the complications of surgical correction of deficient chin by using less invasive approach.

Trial design:

3 Groups of patients will be assigned to this trial: Study group1: Will use autogenous fat augmentation in deficient chin. Study group2: Will use onlay PEEK augmentation in deficient chin. Control group: Surgical correction of deficient chin with sliding genioplasty. Trial design: Randomized Controlled clinical Trial

Eligibility criteria: Inclusion Criteria:

•.Medically free patients.

* Patients with deficient chin..
* Age range is between 18 and 45 years
* No sex predilection.

Exclusion Criteria:

* Patients with systemic condition contraindicating with the surgical procedure.
* Previously corrected chin.
* Patients indicated for other skeletal mandibular procedure during the same surgical session.

Primary outcomes:
measure: soft tissue analysis
timeFrame: year follow up
Secondary outcomes:
Other outcomes:
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Study officials:
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