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
|Condition or disease||Intervention/treatment||Phase|
|Bichat's Fat Pad Atrophy Facial Expression||Procedure: BFP removal||Not Applicable|
|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)|
|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|
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.
- 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.
- 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.
- 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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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974373
|Caio Vinicius Gonçalves Roman Torres|
|Santos, SP, Brazil, 11015001|
|Principal Investigator:||CAIO VINICIUS GONÇALVES R TORRES||Universidade Metropolitana de Santos|