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A Fatty Flap Taken From the Double Chin for Chin Enhancement: a New Surgical Technique

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ClinicalTrials.gov Identifier: NCT05515016
Recruitment Status : Completed
First Posted : August 25, 2022
Last Update Posted : August 25, 2022
Sponsor:
Information provided by (Responsible Party):
Imen Turki Mehri, MD, Mohamed Tahar Maamouri University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Adiposity Micrognathism Procedure: chin enhancement with a fatty flap sculpted from the double chin Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: A Fatty Flap Sculpted From the Double Chin for a Better Face Profile: an Original Technique
Study Start Date : July 2015
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2019
Arms and Interventions
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Arm Intervention/treatment
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.
 Procedure: chin enhancement with a fatty flap sculpted from the double chin
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 Name: submental fatty flap treating the double chin and correcting the micrognathia


Outcome Measures
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Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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.

  5. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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).


Eligibility Criteria
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Ages Eligible for Study:   45 Years to 52 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05515016


Sponsors and Collaborators
Mohamed Tahar Maamouri University Hospital
Investigators
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Principal Investigator: IMEN T MEHRI TURKI, Dr Teaching hospital Mohamed Tahar Maamouri, nabeul
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Imen Turki Mehri, MD, Principal investigator, Mohamed Tahar Maamouri University Hospital
ClinicalTrials.gov Identifier: NCT05515016    
Other Study ID Numbers: Maamouri Teaching hospital
First Posted: August 25, 2022    Key Record Dates
Last Update Posted: August 25, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imen Turki Mehri, MD, Mohamed Tahar Maamouri University Hospital:
Retrognathia
Mandibular advancement
Adipose tissue
Cervicoplasty
Additional relevant MeSH terms:
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Micrognathism
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Maxillofacial Abnormalities
 Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic Diseases
Stomatognathic System Abnormalities
Congenital Abnormalities