- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05515016
A Fatty Flap Taken From the Double Chin for Chin Enhancement: a New Surgical Technique
A Fatty Flap Sculpted From the Double Chin for a Better Face Profile: an Original Technique
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
the surgical technique was performed on 10 participants. written informed consent was obtained from all the participants.
Description of the surgical technique:
The investigators began by delineating the undesirable subplatysmal fat located in the submental region, just below the subcutaneous fat. The skin redundancy assessed by the pinch test was excised. Under general anesthesia, an incision was made behind the submental crease followed by the excision of the skin excess. The subplatysmal fatty compartment was individualized through a subcutaneous dissection. Then, the lower part of the subplatysmal fat was cut to start its separation from the platysma muscle, thus obtaining a real vascularized fatty flap. This flap could be folded on itself, then easily turned over to be fixed on the thin layer of the pre-muscular fat overlying the chin. Hemostasis was performed correctly avoiding the establishment of drainage.
chin projection and submental rejuvenation were obtained. The advancement of the chin ranged from 3,5 to 12 millimeters. The stability of the translated fat was observed after surgery for more than two years.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- the presence of a "double chin" with slightly redundant skin and a "receding chin" causing a fleshy appearing neck, and a disproportion in the face profile
Exclusion Criteria:
- any history of a precedent surgery on the neck, the presence of a traumatic or a burn scar on the cervical region.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: A surgical technique for double chin treatment and chin advancement
the same surgical technique was performed on 10 participants with their consent.
Subplatysmal fat, of the submental region, was dissected from the subcutaneous plan and the platysma muscle, then elevated as a flap to be plicated and turned, then fixed on the muscular layer of the chin.
This technique provides both double chin treatment and chin advancement.
It improves the profile of the face.
|
Under general anesthesia, an incision was made behind the submental crease followed by the excision of the skin excess.
The preplatysmal fatty compartment was individualized through a subcutaneous dissection.
Then, the lower part of the preplatysmal fat was cut to start its separation from the platysma muscle, thus obtaining a real vascularized fatty flap.
This flap could be folded on itself, then easily turned over to be fixed on the muscular layer of the chin.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chin advancement measure
Time Frame: The change of chin projection at 6 months after the surgical procedure
|
For the objective evaluation: Chin advancement was evaluated by measuring, with a Vernier caliper, the distance between the submental crease and the soft tissue at the pogonion.
This distance was taken before and after the surgical procedure.
The advancement of the chin ranged from 3,5 to 12 millimeters (mm).
This measurement was taken by the investigator during the follow-up appointments.
For the subjective evaluation: The results were evaluated on patient reviews and photographic studies (before and after surgery).
|
The change of chin projection at 6 months after the surgical procedure
|
Chin advancement measure
Time Frame: The change of chin projection at 12 months after the surgical procedure
|
For the objective evaluation: Chin advancement was evaluated by measuring, with a Vernier caliper, the distance between the submental crease and the soft tissue at the pogonion.
This distance was taken before and after the surgical procedure.
The advancement of the chin ranged from 3,5 to 12 millimeters (mm).
This measurement was taken by the investigator during the follow-up appointments.
For the subjective evaluation: The results were evaluated on patient reviews and photographic studies (before and after surgery).
|
The change of chin projection at 12 months after the surgical procedure
|
Chin advancement measure assessing the stability of the result
Time Frame: The change of chin projection at 24 months after the surgical procedure
|
For the objective evaluation: Chin advancement was evaluated by measuring, with a Vernier caliper, the distance between the submental crease and the soft tissue at the pogonion.
This distance was taken before and after the surgical procedure.
The advancement of the chin ranged from 3,5 to 12 millimeters (mm).
This measurement was taken by the investigator during the follow-up appointments.
For the subjective evaluation: The results were evaluated on patient reviews and photographic studies (before and after surgery).
|
The change of chin projection at 24 months after the surgical procedure
|
Fat deposits removal in the submental region
Time Frame: At 6 months after the surgical procedure
|
This outcome was evaluated on photos (face and profile) before and after surgery.
A questionnaire including three levels of satisfaction (not satisfied, satisfied, very satisfied) was completed by the participants concerning the surgical outcomes including the submental change and the chin advancement.
|
At 6 months after the surgical procedure
|
Fat deposits removal in the submental region
Time Frame: At 12 months after the surgical procedure
|
This outcome was evaluated on photos (face and profile) before and after surgery.
A questionnaire including three levels of satisfaction (not satisfied, satisfied, very satisfied) was completed by the participants concerning the surgical outcomes including the submental change and the chin advancement.
|
At 12 months after the surgical procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The evaluation of the surgical scar
Time Frame: At 6 months after the surgical procedure
|
The aspect of the scar was evaluated by the investigator by two parameters: the pigmentation (normal colored, hypopigmentation, hyperpigmentation) and the throphycity (hypertrophic, depressive, adequate trophicity).
|
At 6 months after the surgical procedure
|
The evaluation of the surgical scar
Time Frame: At 12 months after the surgical procedure
|
The aspect of the scar was evaluated by the investigator by two parameters: the pigmentation (normal colored, hypopigmentation, hyperpigmentation) and the throphycity (hypertrophic, depressive, adequate trophicity).
|
At 12 months after the surgical procedure
|
Collaborators and Investigators
Investigators
- Principal Investigator: IMEN T MEHRI TURKI, Dr, Teaching hospital Mohamed Tahar Maamouri, nabeul
Publications and helpful links
General Publications
- Shamban AT. Noninvasive Submental Fat Compartment Treatment. Plast Reconstr Surg Glob Open. 2016 Dec 14;4(12 Suppl Anatomy and Safety in Cosmetic Medicine: Cosmetic Bootcamp):e1155. doi: 10.1097/GOX.0000000000001155. eCollection 2016 Dec.
- Strauss RA, Abubaker AO. Genioplasty: a case for advancement osteotomy. J Oral Maxillofac Surg. 2000 Jul;58(7):783-7. doi: 10.1053/joms.2000.7266.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Maamouri Teaching hospital
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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