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

NCT ID: NCT03747822

Last Updated: 2018-11-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-28
• Study Completion Date: 2020-06-30

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

Conditions

Patients With Deficient Chin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

autogenous fat

autogenous fat augmentation in deficient chin will be harvested from lower abdomen,inner or outer thigh

Group Type: ACTIVE_COMPARATOR

fat filler,PEEK,sliding genioplasty

Intervention Type: PROCEDURE

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.

PEEK

Will use onlay PEEK augmentation in deficient chin.Virtual planning will be done using mimics software. A virtual osteotomy of the chin will be performed at the inferior border of the mandible same alignments as sliding genioplasty, then segmentation of the chin area will be done and according to the soft tissue analysis adjustment will be performed.

Group Type: ACTIVE_COMPARATOR

fat filler,PEEK,sliding genioplasty

Intervention Type: PROCEDURE

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.

Osseous sliding genioplasty

Under general anesthesia, the preparation and the incision line will be performed same as PEEK augmentation .After complete exposure of the bone repositioning of the chin will be performed. Finally fixation will be obtained using x shape titanium plate.

Group Type: OTHER

fat filler,PEEK,sliding genioplasty

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

asmaa mohmed helmy

assisstant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

20687

Identifier Type: -

Identifier Source: org_study_id