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Postoperative Evaluation of the Intraoral Technique of Buccal Fat Pad Removal

Primary Purpose

Bichat's Fat Pad Atrophy, Facial Expression

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
BFP removal
Sponsored by
Universidade Metropolitana de Santos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bichat's Fat Pad Atrophy focused on measuring Buccal mucosa

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Caio Vinicius Gonçalves Roman Torres

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BFP removal

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
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

Secondary Outcome Measures

Full Information

First Posted
May 25, 2019
Last Updated
June 3, 2019
Sponsor
Universidade Metropolitana de Santos
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1. Study Identification

Unique Protocol Identification Number
NCT03974373
Brief Title
Postoperative Evaluation of the Intraoral Technique of Buccal Fat Pad Removal
Official Title
Postoperative Evaluation of the Intraoral Technique of Buccal Fat Pad Removal
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2016 (Actual)
Primary Completion Date
December 30, 2017 (Actual)
Study Completion Date
May 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Metropolitana de Santos

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The investigators 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 buccal fat pad 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. The surgical procedure was performed using the technique with intrabuccal access, already consecrated in the literature (Materasso, 2006). The buccal fat pad 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. Patients were adequately medicated with analgesics and anti-inflammatories and antibiotics for 5 days. Kinesio therapy tapes were applied and placed towards the origin for insertion of the muscles involved in the region, and exchanged after 4, 7, and 10 days. Severe bilateral cryotherapy in the areas of extraoral surgery for 24 to 48 hours was performed. The first return was 4 days after the procedure and the next 7, 10, 15, 30, and ninety days, where physical, clinical, standardized photos and oral opening measurements were performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bichat's Fat Pad Atrophy, Facial Expression
Keywords
Buccal mucosa

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BFP removal
Arm Type
Experimental
Arm Description
this will be the group evaluated in this study, individuals who performed the BFP removal procedure.
Intervention Type
Procedure
Intervention Name(s)
BFP removal
Intervention Description
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.
Primary Outcome Measure Information:
Title
Limitation of mouth opening after the surgical procedure
Description
to evaluate during the post-operative period the limitation of mouth opening, by means of manual pachymeter, and measured in millimeters.
Time Frame
90 days
Title
presence of local edema
Description
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.
Time Frame
90 days
Title
The facial contour was modified in the malar region after the surgical procedure.
Description
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
Time Frame
90 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patients with constant lesions caused by bites on the jugal mucosa patients who are dissatisfied with the facial contour. Exclusion Criteria: any systemic problem altered blood tests presence of oral infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CAIO VINICIUS GONÇALVES R TORRES
Organizational Affiliation
Universidade Metropolitana de Santos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Caio Vinicius Gonçalves Roman Torres
City
Santos
State/Province
SP
ZIP/Postal Code
11015001
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
the study participants allowed the use of data only for this study and for this researcher
Citations:
PubMed Identifier
19338917
Citation
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.
Results Reference
background
PubMed Identifier
31073600
Citation
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.
Results Reference
result

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Postoperative Evaluation of the Intraoral Technique of Buccal Fat Pad Removal

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