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Postoperative Evaluation of the Intraoral Technique of Buccal Fat Pad Removal

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ClinicalTrials.gov Identifier: NCT03974373
Recruitment Status : Completed
First Posted : June 4, 2019
Last Update Posted : June 4, 2019
Sponsor:
Information provided by (Responsible Party):
CAIO VINICIUS GONÇALVES ROMAN TORRES, Universidade Metropolitana de Santos

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.

Condition or disease Intervention/treatment Phase
Bichat's Fat Pad Atrophy Facial Expression Procedure: BFP removal Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Postoperative Evaluation of the Intraoral Technique of Buccal Fat Pad Removal
Actual Study Start Date : April 1, 2016
Actual Primary Completion Date : December 30, 2017
Actual Study Completion Date : May 5, 2019

Arm Intervention/treatment
Experimental: BFP removal
this will be the group evaluated in this study, individuals who performed the BFP removal procedure.
Procedure: BFP removal
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 Measures :
  1. Limitation of mouth opening after the surgical procedure [ Time Frame: 90 days ]
    to evaluate during the post-operative period the limitation of mouth opening, by means of manual pachymeter, and measured in millimeters.

  2. presence of local edema [ Time Frame: 90 days ]
    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.

  3. The facial contour was modified in the malar region after the surgical procedure. [ Time Frame: 90 days ]
    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



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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974373


Locations
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Brazil
Caio Vinicius Gonçalves Roman Torres
Santos, SP, Brazil, 11015001
Sponsors and Collaborators
Universidade Metropolitana de Santos
Investigators
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Principal Investigator: CAIO VINICIUS GONÇALVES R TORRES Universidade Metropolitana de Santos

Publications of Results:
Other Publications:
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Responsible Party: CAIO VINICIUS GONÇALVES ROMAN TORRES, Professor, Universidade Metropolitana de Santos
ClinicalTrials.gov Identifier: NCT03974373     History of Changes
Other Study ID Numbers: SantosMU5
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: the study participants allowed the use of data only for this study and for this researcher

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by CAIO VINICIUS GONÇALVES ROMAN TORRES, Universidade Metropolitana de Santos:
Buccal mucosa

Additional relevant MeSH terms:
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Atrophy
Pathological Conditions, Anatomical