NCT05515016

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 25, 2022

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2022

Enrollment Period

2.3 years

First QC Date

August 18, 2022

Last Update Submit

August 23, 2022

Conditions

Keywords

RetrognathiaMandibular advancementAdipose tissueCervicoplasty

Outcome Measures

Primary Outcomes (5)

  • 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).

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

  • 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).

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

  • 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).

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

  • 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.

    At 6 months after the surgical procedure

  • 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.

    At 12 months after the surgical procedure

Secondary Outcomes (2)

  • The evaluation of the surgical scar

    At 6 months after the surgical procedure

  • The evaluation of the surgical scar

    At 12 months after the surgical procedure

Study Arms (1)

A surgical technique for double chin treatment and chin advancement

OTHER

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

Interventions

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.

Also known as: submental fatty flap treating the double chin and correcting the micrognathia
A surgical technique for double chin treatment and chin advancement

Eligibility Criteria

Age45 Years - 52 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

Related Links

MeSH Terms

Conditions

ObesityMicrognathismRetrognathia

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsJaw AbnormalitiesJaw DiseasesMusculoskeletal DiseasesMaxillofacial AbnormalitiesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesStomatognathic DiseasesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMandibular Diseases

Study Officials

  • IMEN T MEHRI TURKI, Dr

    Teaching hospital Mohamed Tahar Maamouri, nabeul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 18, 2022

First Posted

August 25, 2022

Study Start

July 1, 2015

Primary Completion

October 1, 2017

Study Completion

October 1, 2019

Last Updated

August 25, 2022

Record last verified: 2022-08