NCT03974373

Brief Summary

In recent years there has been a growing number of procedures for the removal of the buccal fat pad (BFP) or as frequently referred to as bichectomy. Buccal fat pad removal can be used as part of the therapeutic procedure in cases of: sinus buco fistulas, peri-orbital defects, congenital palatal fissure, patients with severe bruxism, patients with constant lesions caused by bites on the jugal mucosa and in patients who are dissatisfied with the facial contour. In cases of thinning of the face, biting lesions and bruxism, total or partial of the BFP removal is performed, always taking into account a facial harmonization. The aim of the present study was to demonstrate the procedure of BFP removal and its respective postoperative period. A total of 40 BFP removal surgeries were performed between 2016 and 2017 with intraoral access technique. After the bichectomy procedure the subjects were followed for: 4, 7, 10, 15, 30, and 90 days. The postoperative period can be compared to that of a third molar extraction, and the use of analgesics and anti-inflammatories can adequately control the pain symptomatology. Edema and mouth opening limited for about 15 days were the most commonly found alterations in surgeries performed. The surgical technique is a simple and safe procedure provided by trained and experienced professionals. The bichectomy should be performed following a precise indication and the procedure is becoming a new area of practice for the dental surgeon, who can perform the procedure safely, reliably and with aesthetic and therapeutic results provided that with precise indications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2017

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2019

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 4, 2019

Completed
Last Updated

June 5, 2019

Status Verified

June 1, 2019

Enrollment Period

1.7 years

First QC Date

May 25, 2019

Last Update Submit

June 3, 2019

Conditions

Keywords

Buccal mucosa

Outcome Measures

Primary Outcomes (3)

  • Limitation of mouth opening after the surgical procedure

    to evaluate during the post-operative period the limitation of mouth opening, by means of manual pachymeter, and measured in millimeters.

    90 days

  • presence of local edema

    to evaluate in the post-operative period the presence of local edema. the presence of local edema will be verified through the patient's report, and the researcher's preservation through the photographs obtained in the preoperative period.

    90 days

  • The facial contour was modified in the malar region after the surgical procedure.

    photographs obtained before and after the surgical procedure will be placed in the PortraitPro 11 software and assessed for facial contour. The observed difference will be measured in millimeters

    90 days

Study Arms (1)

BFP removal

EXPERIMENTAL

this will be the group evaluated in this study, individuals who performed the BFP removal procedure.

Procedure: BFP removal

Interventions

BFP removalPROCEDURE

The surgical procedure was performed using the technique with intrabuccal access, already consecrated in the literature (Materasso 2006). The Bichat fat ball access was made by means of a small incision no more than 3 mm in length in the soft tissue located in the lower aspect of the zygomatic counterfoot, taking care to visualize and protect with the retractor the Stensen's conduit. With the aid of blunt-tipped or hemostatic scissors dissection was performed, taking care to preserve the membrane surrounding the ball of fat. After removal of one side, pressure was removed to remove air and the procedure was started on the opposite side, after the removal of the two sides was realized simple suture with silk thread. There were no formal indications for sending the samples for anatomic and / or histological examination.

BFP removal

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • patients with constant lesions caused by bites on the jugal mucosa
  • patients who are dissatisfied with the facial contour.

You may not qualify if:

  • any systemic problem
  • altered blood tests
  • presence of oral infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caio Vinicius Gonçalves Roman Torres

Santos, São Paulo, 11015001, Brazil

Location

Related Publications (2)

  • Matarasso A. Managing the buccal fat pad. Aesthet Surg J. 2006 May-Jun;26(3):330-6. doi: 10.1016/j.asj.2006.03.009.

    PMID: 19338917BACKGROUND
  • Matarasso A. Commentary on: Buccal Fat Pad Excision: Hydrodissection Technique. Aesthet Surg J. 2019 Sep 13;39(10):1046-1047. doi: 10.1093/asj/sjz086. No abstract available.

MeSH Terms

Conditions

Facial Expression

Condition Hierarchy (Ancestors)

Nonverbal CommunicationCommunicationBehavior

Study Officials

  • CAIO VINICIUS GONÇALVES R TORRES

    Universidade Metropolitana de Santos

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: We included in the present study 40 patients who sought the UNIMES Dentistry Clinic for the BFP removal procedure. All female, aged between 20 and 40 years and showing good general health. All the patients received information and had access to the informed consent form that after the necessary explanations was duly filled and signed. Clinical parameters such as periodontal indices (depth of probing, plaque index and gingival index), characteristics of the jugal mucosa, opening of the mouth, and the amount of fat removed were evaluated. After detailed anamnesis and verified the need to remove the fat ball by constant bite on the jugal mucosa or for aesthetic reasons of facial thinning the patients were instructed to perform the blood tests, fasting blood glucose and complete blood count. With the exams presenting normal levels and compatible with health status, the patients were scheduled to perform the proposed therapy.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 25, 2019

First Posted

June 4, 2019

Study Start

April 1, 2016

Primary Completion

December 30, 2017

Study Completion

May 5, 2019

Last Updated

June 5, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

the study participants allowed the use of data only for this study and for this researcher

Locations