Evaluation of facial contour changes following buccal fat pad removal surgery
Design
A clinical non randomised trial, without controlled group, phase 2 on 15 patients, with postoperative care and outcome assessment
Settings and conduct
Location: Tehran Farhikhtegan Hospital
Preparation of preoperative images: 3-D scans, 2-D photography in frontal and left and right profile and left and right 45 degree view, Ultrasound from each site of the face
Method: injection of local anesthesia Lidocaine 2% in buccal area. Make an incision about 1cm between Parotid duct and buccal vestibula in the vicinity of upper 6 tooth, take out buccal fat pad without any external force, suturing of incision with resorbable suture 3_0.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Medium body size
Normal facial muscles function
Normal facial nerve function
Among 20 to 50 years old
Exclusion criteria:
Systemic diseases
An history of trauma in the face area
An history of surgery in the face area
An history of filler or botox injection in the face area
Using anticoagulant drugs
Intervention groups
Buccal fat pad removal surgery and its effect on facial buccal contour by using 3-D scanner device before and after of operation. There is no control group.
Main outcome variables
Facial buccal contour
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230909059385N1
Registration date:2023-09-18, 1402/06/27
Registration timing:prospective
Last update:2023-09-18, 1402/06/27
Update count:0
Registration date
2023-09-18, 1402/06/27
Registrant information
Name
Marjan Hosseinpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4482 1976
Email address
marjan.hosseinpour6623@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2023-10-07, 1402/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of facial contour changes following buccal fat pad removal surgery
Public title
Evaluation of Buccal fat pad removal surgery on facial contour
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Individuals applying buccal fat pad removal surgery
Medium body size
Individuals in between 20-50 years old
Normal facial muscles function
Normal facial nerve function
Exclusion criteria:
Lactating and pregnant mothers
Patients with acute and chronic diseases
History of trauma
Taking anticoagulant drugs
Masseter muscle hypertrophy
Mandibular angle hypertrophy
Weight changes during the study
Age
From 20 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
15
More than 1 sample in each individual
Number of samples in each individual:
2
Buccal face contour on each side of the face
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Using a 3_D scanning device in order to examin changes in facial contour
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran Azad University of Medical Sciences
Street address
Tehran Islamic Azad University of Medical Sciences, Khaghani Ave., Shariati Ave.
City
Tehran
Province
Tehran
Postal code
1916893813
Approval date
2023-06-12, 1402/03/22
Ethics committee reference number
IR.IAU.DENTAL.REC.1402.049
Health conditions studied
1
Description of health condition studied
Buccal fat pad
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Facial buccal contour
Timepoint
Before operation and 6 monthes after operation
Method of measurement
3-D scanner device and questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Buccal fat pad removal surgery
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Farhikhtegan Hospital
Full name of responsible person
Marjan hosseinpour
Street address
Farhikhtegan Hospital, Sattari Expy
City
Tehran
Province
Tehran
Postal code
1469856333
Phone
+98 912 226 9748
Email
Marjan.hosseinpour6623@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Masoud Parsania
Street address
Headquarters of Tehran Medical Science of Islamic Azad University, Gole Yakh Ave., Aeine Blvd., Shariati Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2264 0599
Fax
+98 21 2264 0599
Email
iuc@iautmu.ac.ir
Web page address
http://tms.iau.ir/research/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Marjan Hosseinpour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 19, East 17 Ave., 12 Bahman Ave., Simon Bolivar Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1469856333
Phone
+98 21 4482 1976
Email
Marjan.hosseinpour6623@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Marjan Hosseinpour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 19, East 17 Ave., 12 Bahman Ave., Simon Bolivar Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1469856333
Phone
+98 21 4482 1976
Email
marjan.hosseinpour6623@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Marjan Hosseinpour
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 19, East 17 Ave., 12 Bahman Ave., Simon Bolivar Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1469856333
Phone
+98 21 4482 1976
Email
marjan.hosseinpour6623@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Because of moral issues
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available