A Fatty Flap Taken From the Double Chin for Chin Enhancement: a New Surgical Technique
Primary Purpose
Adiposity, Micrognathism
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
chin enhancement with a fatty flap sculpted from the double chin
Sponsored by
About this trial
This is an interventional treatment trial for Adiposity focused on measuring Retrognathia, Mandibular advancement, Adipose tissue, Cervicoplasty
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
A surgical technique for double chin treatment and chin advancement
Arm Description
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.
Outcomes
Primary Outcome Measures
Chin advancement measure
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).
Chin advancement measure
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).
Chin advancement measure assessing the stability of the result
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).
Fat deposits removal in the submental region
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.
Fat deposits removal in the submental region
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.
Secondary Outcome Measures
The evaluation of the surgical scar
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).
The evaluation of the surgical scar
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).
Full Information
NCT ID
NCT05515016
First Posted
August 18, 2022
Last Updated
August 23, 2022
Sponsor
Mohamed Tahar Maamouri University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05515016
Brief Title
A Fatty Flap Taken From the Double Chin for Chin Enhancement: a New Surgical Technique
Official Title
A Fatty Flap Sculpted From the Double Chin for a Better Face Profile: an Original Technique
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mohamed Tahar Maamouri University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The double chin is a troublesome component of the lower third of the face. It gives an embarrassing and unpleasant facial appearance to both men and women leading them to ask for liposuction. Moreover, a "receding chin" causes blunting of the cervico-mental angle, a fleshy appearing neck, a disproportion in the profile line of the face with a prominent looking nose, and an irregular mandibular border. This study is about an innovative surgical procedure: Instead of doing liposuction of the double chin, the investigators used the fat of this area as a flap to improve a "receding chin". hence both the double chin and the receding chin are treated.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adiposity, Micrognathism
Keywords
Retrognathia, Mandibular advancement, Adipose tissue, Cervicoplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The same surgical procedure was performed on 10 participants. These participants had a double chin with skin redundancy and a receding chin. The result was evaluated with photos and chin advancement was measured with a Vernier caliper.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A surgical technique for double chin treatment and chin advancement
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
chin enhancement with a fatty flap sculpted from the double chin
Other Intervention Name(s)
submental fatty flap treating the double chin and correcting the micrognathia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Chin advancement measure
Description
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).
Time Frame
The change of chin projection at 6 months after the surgical procedure
Title
Chin advancement measure
Description
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).
Time Frame
The change of chin projection at 12 months after the surgical procedure
Title
Chin advancement measure assessing the stability of the result
Description
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).
Time Frame
The change of chin projection at 24 months after the surgical procedure
Title
Fat deposits removal in the submental region
Description
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.
Time Frame
At 6 months after the surgical procedure
Title
Fat deposits removal in the submental region
Description
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.
Time Frame
At 12 months after the surgical procedure
Secondary Outcome Measure Information:
Title
The evaluation of the surgical scar
Description
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).
Time Frame
At 6 months after the surgical procedure
Title
The evaluation of the surgical scar
Description
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).
Time Frame
At 12 months after the surgical procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
52 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
IMEN T MEHRI TURKI, Dr
Organizational Affiliation
Teaching hospital Mohamed Tahar Maamouri, nabeul
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
28018773
Citation
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.
Results Reference
result
PubMed Identifier
10883694
Citation
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.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/28018773/
Description
Noninvasive Submental Fat Compartment Treatment
URL
https://pubmed.ncbi.nlm.nih.gov/10883694/
Description
Genioplasty: a case for advancement osteotomy
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A Fatty Flap Taken From the Double Chin for Chin Enhancement: a New Surgical Technique
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