- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03974373
Postoperative Evaluation of the Intraoral Technique of Buccal Fat Pad Removal
June 3, 2019 updated by: CAIO VINICIUS GONÇALVES ROMAN TORRES, Universidade Metropolitana de Santos
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
SP
-
Santos, SP, Brazil, 11015001
- Caio Vinicius Gonçalves Roman Torres
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: BFP removal
this will be the group evaluated in this study, individuals who performed the BFP removal procedure.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
90 days
|
|
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.
|
90 days
|
|
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
|
90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: CAIO VINICIUS GONÇALVES R TORRES, Universidade Metropolitana de Santos
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2016
Primary Completion (Actual)
December 30, 2017
Study Completion (Actual)
May 5, 2019
Study Registration Dates
First Submitted
May 25, 2019
First Submitted That Met QC Criteria
June 3, 2019
First Posted (Actual)
June 4, 2019
Study Record Updates
Last Update Posted (Actual)
June 5, 2019
Last Update Submitted That Met QC Criteria
June 3, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SantosMU5
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
the study participants allowed the use of data only for this study and for this researcher
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Facial Expression
-
Arkansas Children's Hospital Research InstituteCompletedFacial ExpressionUnited States
-
University of Nove de JulhoRecruitingWrinkle | Facial ExpressionBrazil
-
Assistance Publique - Hôpitaux de ParisNot yet recruitingSmile | Smile EstheticsFrance
-
Mohamed Hayder Oleish SalihCompletedGlabellar Frown Lines | Wrinkle | Facial Expression | RhytidesEgypt
-
University of OxfordMedical Research Council; P1vital Products LimitedCompletedEmotion | Bright Light Treatment | Facial Expression RecognitionUnited Kingdom
-
Seoul National University Bundang HospitalRecruitingPain, Postoperative | Analgesia | Artificial Intelligence | Facial ExpressionKorea, Republic of
-
Suez Canal UniversityCompletedPostoperative Pain | Facial Expressions | Root Canal Treatment in Children Primary Molars | Facial Emotions | Artificial Intelligence Mobile Application | Sonic ActivationEgypt
-
Second Affiliated Hospital of Nanchang UniversityRecruitingSmall-incision Lenticule Extraction (SMILE) Surgery | Corneal Higher-order Wavefront Aberrations | Residual LenticuleChina
-
University Hospital, BrestCompletedDry Eye | Dry Eye After LASIK-Laser in Situ KeratomileusisFrance
-
Laval UniversityCompleted
Clinical Trials on BFP removal
-
VA Office of Research and DevelopmentCompletedSchizophreniaUnited States
-
NYU Langone HealthCompletedBreast CancerUnited States
-
Nuh Naci Yazgan UniversityActive, not recruiting
-
Charite University, Berlin, GermanyUniversity Medicine Greifswald; Rheinisch-Westfälische Technische Hochschule...Unknown
-
Fudan UniversityNot yet recruitingInguinal Hernia Repair | Mesh Infection
-
Cukurova UniversityRecruitingPulp Exposure, Dental | Deep Dental CariesTurkey (Türkiye)
-
IRCCS San RaffaeleCompletedPancreatic Fistula | Complication,Postoperative | PROMs | Pancreas DiseaseItaly
-
Peking Union Medical College HospitalPeking University First Hospital; Cancer Institute and Hospital, Chinese Academy... and other collaboratorsCompletedDrainage | PancreaticoduodenectomyChina
-
Peking Union Medical College HospitalUnknownPancreatectomy | Post Procedural DischargeChina
-
Vanderbilt UniversityUnited States Surgical CorporationCompletedObesity | Dyslipidemia | Hypercholesterolemia | Diabetes Mellitus Type 2United States