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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
Mohamed Tahar Maamouri University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adiposity focused on measuring Retrognathia, Mandibular advancement, Adipose tissue, Cervicoplasty

Eligibility Criteria

45 Years - 52 Years (Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 18, 2022
    Last Updated
    August 23, 2022
    Sponsor
    Mohamed Tahar Maamouri University Hospital
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    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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