The effects of using Buccal Fat pad on dorsum changes
Design
This study is a single blind randomized clinical trial with control group. 20 patients will be randomly divided into two groups of intervention (I) or control (C).
Settings and conduct
This single blind study(The person who measures the outcome will be unaware of the groups) will be performed in Beast hospital of Hamadan to determine the effect of using Buccal Fat pad on dorsum changes In patients undergoing primary rhinoplasty
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patient satisfaction to participate in the study, age 18 - 40 years old, Class I according to the American Association of Anesthesiologists (ASA I) exclusion criteria: History of nose trauma, History of respiratory problems and History of previous rhinoplasty
Intervention groups
In patients undergoing primary rhinoplasty, after romoval of nasal bridge bone and before the suture of the nasal skin, with small incision in the oral cavity a small amount of buccal fat is removed and to be laid on the nasal dorsum and will be fixed to this area then skin will be sutured. In the control group, the skin is sutured without use of buccal fat.
Main outcome variables
Nasal bridge beauty change
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120531009926N8
Registration date:2020-03-25, 1399/01/06
Registration timing:retrospective
Last update:2020-03-25, 1399/01/06
Update count:0
Registration date
2020-03-25, 1399/01/06
Registrant information
Name
Mohammad Reza Jamalpour
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1826 0356
Email address
jamalpour@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-21, 1398/01/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of using Buccal Fat pad on dorsum changes.
Public title
The effects of using Buccal Fat pad on dorsum changes.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient satisfaction to participate in the study
age 18 - 40 years old
American Society of Anesthesiologists class I (ASA I)
Exclusion criteria:
History of nose trauma
History of respiratory problems
History of previous rhinoplasty
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
We made 20 cards and wrote letter I on 10 for intervention and on the other 10, letter C for the control group. Then we put them inside the envelope with aluminum wrap then we'll put it in the box. At the time of patient arrival, one of the envelopes will be randomly selected and opened. based on selected letter ( I or C), patients will be assigned to intervention or control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the individual who evaluating the outcome of the intervention will be unaware of the intervention and control groups, Therefore, the study will be single blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamedan University of medical sciences
Street address
Shahid Fahmideh
City
Hamadan
Province
Hamadan
Postal code
6517838677
Approval date
2018-04-13, 1397/01/24
Ethics committee reference number
IR.UMSHA.REC.1398.006
Health conditions studied
1
Description of health condition studied
Rhinoplasty
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Nasal bridge Beauty changes.
Timepoint
Immediately after splint removal and at 2, 4 and 6 months after surgery
Method of measurement
Patients' satisfaction of nasal dorsum with Visual Analogue Scale (VAS) and Facial Outcome Evaluation(FOE)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In intervention group open techniques for Primary Rhinoplasty will be used. with small incision in the maxillary vestibular area, buccal fat pad with tissues attached to it is retained to provide tissue nutrition during surgery and incision site will be sutured. After the end of the osteotomy and before the suture of the nasal skin, a layer of fat tissue removed from the mouth is inserted on the nasal dorsum and fixed.
Category
Treatment - Surgery
2
Description
Control group: In the control group, In this group, primary rhinoplasty surgery will be performed with open technique and after the end of the osteotomy, nasal skin will be immediately sutured without use of buccal fat
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Oral and Maxillofacial Surgery Clinic, Besat Hospital, Hamadan
Full name of responsible person
Dr.Mohammadreza Jamalpoor
Street address
Besat Hospital, Shahid Beheshti Blv, Hamedan
City
Hamedan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3264 0081
Email
Besat@Umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Vice-chancellor for research and technology, Shahid Fahmideh, Hamadan
City
Hamedan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3264 0081
Email
vc_research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
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
Hamedan University of Medical Sciences
Full name of responsible person
Dr Mohammadreza Jamalpoor
Position
Associate professor of Hamadan Dental School
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahid Beheshti Ave, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3264 0081
Email
jamalpour1972@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Mohammadreza Jamalpoor
Position
Associate Professor , Faculty of Dentistry, Hamadan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahid Beheshti Ave, Hamadan
City
Hamedan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3264 0081
Email
jamalpour1972@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Mohammadreza Jamalpoor
Position
Professor, Faculty of Dentistry, Hamadan University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahid Beheshti Ave, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3264 0081
Email
jamalpour1972@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
Proposal and method of conducting the study can be shared in areas specified by citing the source
When the data will become available and for how long
21/3/219 to 19/3/2020
To whom data/document is available
Oral and Maxillary Surgeons and Researchers
Under which criteria data/document could be used
To improve rhinoplasty surgical treatment
From where data/document is obtainable
Dr.mohammadreza jamalpoor
What processes are involved for a request to access data/document