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AdiposityNCT05515016

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

A study testing chin enhancement with a fatty flap sculpted from the double chin in people with Adiposity and Micrognathism, run by Mohamed Tahar Maamouri University Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 52 years
Conditions the study is for
Adiposity, Micrognathism
What is being tested?
chin enhancement with a fatty flap sculpted from the double chin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
No sites listed yet
Study dates
Jul 2015to Oct 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 52 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • any history of a precedent surgery on the neck, the presence of a traumatic or a burn scar on the cervical region.

About this study

Official title: A Fatty Flap Sculpted From the Double Chin for a Better Face Profile: an Original Technique

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.

Read the 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.

Being tested
chin enhancement with a fatty flap sculpted from the double chin
Keywords
Retrognathia, Mandibular advancement, Adipose tissue, Cervicoplasty
Medical subject headings
Obesity, Micrognathism, Retrognathia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • chin enhancement with a fatty flap sculpted from the double chinProcedure or surgery

    Also called submental fatty flap treating the double chin and correcting the micrognathia

    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.

Study groups in NCT05515016
Study groupRoleWhat they receive
A surgical technique for double chin treatment and chin advancementOtherthe 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.
Receives: Procedure: chin enhancement with a fatty flap sculpted from the double chin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: The change of chin projection at 6 months after the surgical procedure

  2. 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).

    Measured: The change of chin projection at 12 months after the surgical procedure

  3. 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).

    Measured: The change of chin projection at 24 months after the surgical procedure

  4. 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.

    Measured: At 6 months after the surgical procedure

  5. 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.

    Measured: At 12 months after the surgical procedure

Secondary outcomes (2)

  1. 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).

    Measured: At 6 months after the surgical procedure

  2. 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).

    Measured: At 12 months after the surgical procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2022
  2. Study startJul 2015
  3. Primary completionOct 2017
  4. Study completionOct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05515016
Sponsor's protocol ID
Maamouri Teaching hospital
Status last verified
Aug 2022
First submitted
18 Aug 2022
Last updated
25 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 28018773

  • 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.

    PubMed 10883694

Questions about this trial

What is this clinical trial studying?

A study testing chin enhancement with a fatty flap sculpted from the double chin in people with Adiposity and Micrognathism, run by Mohamed Tahar Maamouri University Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Chin advancement measure (time frame: The change of chin projection at 6 months after the surgical procedure). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05515016, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022.

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