Effect of photo-biomodulation on recovery from neurosensory disturbances after genioplasty and LPRF insertion
Design
Triple blind randomized split mouth clinical trial for patients who are candidates for genioplasty .
One side was designated as a intervention side (accidentally chosen by computer) and the other as the control side. On the control side, the laser probe will be turned off and will be placed on the designated area.
To asses neurosensory recovery , five subjective and objective tests will be used included visual analog scales (VAS) for general sensitivity, directional discrimination, two point discrimination, pain discrimination and thermal discrimination 1-14-28-56 days post surgery by a clinician unaware of laser therapy.
Settings and conduct
Triple blind randomized split mouth clinical trial for patients who are candidates for genioplasty referred to Laleh hospital, Tehran, Iran, from July 2023 to August 2023.
Surgical approach:
The procedure will be performed under general anesthesia.
Then LPRF will be fixed by vicryl 4-0 sutures around bilateral mental nerves.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
All patients needed genioplasty.
Exclusion criteria:
Patients with history of previous trauma to mandible and chin region or mental nerve; History of previous BSSO or Genioplasty ;Patients who do not agree to participate the research.
Intervention groups
Photo-biomodulation therapy will be performed immediately post surgery and 4-6 weeks (twice weekly). On the control side, the laser probe will be turned off on the designated area.
To asses neurosensory recovery , five tests will be performed on 1-14-28-56 days post surgery by a clinician unaware of laser therapy.
Main outcome variables
It is proposed that neurosensory disturbances on control and intervention sides will be different.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230619058536N1
Registration date:2023-07-06, 1402/04/15
Registration timing:prospective
Last update:2023-07-06, 1402/04/15
Update count:0
Registration date
2023-07-06, 1402/04/15
Registrant information
Name
Parsa Behnia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2242 6454
Email address
parsabehnia1@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-11, 1402/04/20
Expected recruitment end date
2023-08-11, 1402/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Leukocyte Platelet-rich Fibrin And Low level laser on acceleration of neurosensory recovery following Genioplasty
Public title
Comparison of Leukocyte Platelet-rich Fibrin And Low level laser on acceleration of neurosensory recovery following Genioplasty
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient who are candidate for genioplasty
Exclusion criteria:
Patients who have a history of trauma in the mandible area, especially in the chin area
They were previously subjected to similar orthognathic surgery (SSO or Genioplasty).
Obvious nerve damage occurs during surgery or the nerve is not identified during surgery.
Patients who use psychiatric drugs.
People who do not want to participate in the study.
Nerve damage has occurred in the past for other reasons.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
16
Randomization (investigator's opinion)
Randomized
Randomization description
One side of the mandible is designated as intervention side and the other as the control side ,in the first patient right side will be chosen as intervention side and this will be continued in every other patient.
Blinding (investigator's opinion)
Triple blinded
Blinding description
On the control side, the laser probe will be turned off and will be placed on the designated area; the device will not be activated, so patients will not be aware of which side will being radiated by laser.
neurosensory evaluation will be performed by a person who is not aware of which side the laser will be radiated.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of AJA University of Medical Sciences
Street address
No. 3, 21 St, Velenjak Ave
City
Tehran
Province
Tehran
Postal code
1985878354
Approval date
2023-05-15, 1402/02/25
Ethics committee reference number
IR.AJAUMS.REC.1402.028
Health conditions studied
1
Description of health condition studied
Trauma to mental nerve ( following genioplasty )
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
To asses post trauma (genioplasty) neurosensory recovery of mental nerve
Timepoint
1-14-28-56 days post surgery by a clinician unaware of laser therapy.
Method of measurement
To asses neurosensory recovery , five subjective and objective tests will be used included Visual Analog Scales (VAS) for general sensitivity, directional discrimination, two point discrimination, pain discrimination and thermal discrimination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Photo-biomodulation therapy will be performed immediately post surgery and 4-6 weeks (twice weekly).
Category
Rehabilitation
2
Description
Control group: On the control side, the laser probe will be turned off and will be placed on the designated area.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Laleh hospital
Full name of responsible person
Parsa Behnia
Street address
South Falamak St , Simaye Iran St , Shahrak Gharb
City
Tehran
Province
Tehran
Postal code
1467684595
Phone
+98 21 8856 3020
Email
parsabehnia1@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Dr Reza Fekrazad
Street address
13 St , Ajoodanieh
City
Tehran
Province
Tehran
Postal code
1919141171
Phone
+98 21 2266 7637
Email
parsabehnia1@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh University of Medical Sciences
Proportion provided by this source
10
Public or private sector
Private
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
Artesh University of Medical Sciences
Full name of responsible person
Parsa Behnia
Position
Post-graduate student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 3, 21 St , Velenjak
City
Tehran
Province
Tehran
Postal code
1985838754
Phone
+98 21 2242 6454
Email
parsabehnia1@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Parsa Behnia
Position
Post-graduate student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 3, 21 St , Velenjak
City
Tehran
Province
Tehran
Postal code
1985838754
Phone
+98 21 2242 6454
Email
parsabehnia1@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Parsa Behnia
Position
Post-graduate student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 3, 21 St , Velenjak
City
Tehran
Province
Tehran
Postal code
1985838754
Phone
+98 21 2242 6454
Email
parsabehnia1@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
Yes - There is 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
Yes - There is 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
The data of all of the main variables of the split mouth designed research can be shared.
When the data will become available and for how long
6 months post publication the data may be released.
To whom data/document is available
Data will be shared with all researchers.
Under which criteria data/document could be used
Correct citation of the shared data and the name of all researchers in the future research using the data .
From where data/document is obtainable
Dr Parsa Behnia
Cell phone : 09122979748
Address : No.3 , 21 St , Velenjak , Tehran , Iran
1985878354
parsabehnia1@gmail.com
What processes are involved for a request to access data/document