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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05515016
Other study ID # Maamouri Teaching hospital
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2015
Est. completion date October 2019

Study information

Verified date August 2022
Source Mohamed Tahar Maamouri University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date October 2019
Est. primary completion date October 2017
Accepts healthy volunteers No
Gender All
Age group 45 Years to 52 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Mohamed Tahar Maamouri University Hospital

References & 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. — View Citation

Strauss RA, Abubaker AO. Genioplasty: a case for advancement osteotomy. J Oral Maxillofac Surg. 2000 Jul;58(7):783-7. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 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). At 6 months after the surgical procedure
Secondary 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). At 12 months after the surgical procedure
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