Patients With Deficient Chin
Conditions
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 calledpreadipocytes2, 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
Interventions
PROCEDUREfat 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
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
a third party oral surgery specialist will be asked to assess the study participate according to a standardized assessment tool
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| soft tissue analysis | year follow up | assessment of soft tissue profile changes using computerized software ,land marks will be determined on soft tissue mask of patient's cone beam computed tomography (cbct) .The Frankfort horizontal (FH) plane will be chosen as a reference line .Horizontal soft tissue changes will be recorded parallel to the FH line and perpendicular on the nasion vertical (NV), whereas the vertical soft tissue changes will be recorded parallel to the NV and perpendicular on the FH line.The advancement will be measured by the change in the position of point Pg preoperatively and postoperatively (T2) from the NV line.The points (Pg, Pg', Me, Me', and B) will be measured for vertical and horizontal movements by a line from each point and perpendicular to the NV and the FH |
Outcome results
None listed