Bichat's Fat Pad AtrophyNCT03974373
Postoperative Evaluation of the Intraoral Technique of Buccal Fat Pad Removal
A study testing BFP removal in people with Bichat's Fat Pad Atrophy and Facial Expression, run by Universidade Metropolitana de Santos at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bichat's Fat Pad Atrophy, Facial Expression
- What is being tested?
- BFP removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2016to 5 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients with constant lesions caused by bites on the jugal mucosa
- patients who are dissatisfied with the facial contour.
Who cannot join
- any systemic problem
- altered blood tests
- presence of oral infection
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Bichat's Fat Pad Atrophy, Facial Expression
- Being tested
- BFP removal
- Keywords
- Buccal mucosa
- Medical subject headings
- Facial Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BFP removalProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| BFP removal | Experimental | this will be the group evaluated in this study, individuals who performed the BFP removal procedure. Receives: Procedure: BFP removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start1 Apr 2016
- Primary completion30 Dec 2017
- Study completion5 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bichat's Fat Pad AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Metropolitana de Santos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CAIO VINICIUS GONÇALVES ROMAN TORRES, Universidade Metropolitana de Santos
- Investigators
- CAIO VINICIUS GONÇALVES R TORRES, Principal investigator, Universidade Metropolitana de Santos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03974373
- Sponsor's protocol ID
- SantosMU5
- Status last verified
- Jun 2019
- First submitted
- 25 May 2019
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the study participants allowed the use of data only for this study and for this researcher
Publications
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.
PubMed 19338917Matarasso 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.
PubMed 31073600
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Evaluation of the Intraoral Technique of Buccal Fat Pad Removal
- ClinicalTrials.gov ID
- NCT03974373
- Acronym / sponsor ID
- SantosMU5
- Conditions
- Bichat's Fat Pad Atrophy, Facial Expression
- Keywords
- Buccal mucosa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidade Metropolitana de SantosUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 5 May 2019 (actual)
- First posted
- 4 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| BFP removal | Experimental | Procedure: BFP removalthis will be the group evaluated in this study, individuals who performed the BFP removal procedure. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- patients with constant lesions caused by bites on the jugal mucosa
- patients who are dissatisfied with the facial contour.
Key exclusion criteria (3 listed)
- any systemic problem
- altered blood tests
- presence of oral infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BFP removalThe 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. | Procedure or surgery | BFP removal |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
- Background: PubMed 19338917Matarasso 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 publication: PubMed 31073600Matarasso 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.
- Individual participant dataSharing planned: No. the study participants allowed the use of data only for this study and for this researcher
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CAIO VINICIUS GONÇALVES R TORRES principal investigator
Universidade Metropolitana de Santos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BFP removal in people with Bichat's Fat Pad Atrophy and Facial Expression, run by Universidade Metropolitana de Santos at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Limitation of mouth opening after the surgical procedure (time frame: 90 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03974373, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2019.