Determining the effect of low power laser in reducing pain, edema and ecchymosis following rhinoplasty in the Department of Oral and Maxillofacial Surgery of Azad Islamic Dental School of Tehran in 1402
Design
The study is a single-blind randomized clinical trial phase3 with 44 patients with the rand option of Excel software using the method of 4 randomized blocks of two intervention and control groups.
Settings and conduct
The number of 44 patients eligible for rhinoplasty for cosmetic or functional reasons were treated in the hospitals of Tehran Islamic Azad University of Medical Sciences in a one-sided blind randomized manner by a statistician.
The person who measures the consequences of the intervention will be blind to the intervention.in intervention group patients will be divided into two control groups. The process of using the laser will be done in the private office of the supervisor. before and after surgery will be used
Participants/Inclusion and exclusion criteria
Inclusion criteria:surgery for cosmetic or functional reasons, absence of birth defects; Exclusion criteria: the presence of contraindications to the use of corticosteroids, hypertension and stomach ulcers, the presence of neurological and mental diseases, the presence of sensitivity or risk to the use of low-power lasers, a woman in the period of menopause.
Intervention groups
In all patients, 8 mg of dexamethasone will be used one hour before surgery, 24 hours and 48 hours after surgery, and antibiotic prophylaxis regimen including 500 mg of cephalexin will be used for 5 days, and only steroid analgesics will be Acetaminophen. The control group will only use the protocols mentioned above and in the intervention group, photobiomodulation therapy immediately after surgery and continue it 48 hours and 72 hours after surgery.
Main outcome variables
Reduction of edema, reduction of ecchymosis, reduction of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230515058195N1
Registration date:2023-05-29, 1402/03/08
Registration timing:prospective
Last update:2023-05-29, 1402/03/08
Update count:0
Registration date
2023-05-29, 1402/03/08
Registrant information
Name
Bardia Afshar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3669 3358
Email address
bardiaafshar123@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-10, 1402/03/20
Expected recruitment end date
2023-12-07, 1402/09/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Low Level Laser Therapy on edema ecchymosis and pain after Rhino plastic surgery
Public title
Evaluation of Low Level Laser Therapy on edema ecchymosis and pain after Rhino plastic surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients in demand for rhinoplasty for functional or cosmetic reasons
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into intervention and control groups by using the rand option of Excel software and by the method of 4 blocks
Blinding (investigator's opinion)
Single blinded
Blinding description
The data allocation process was done by the statistical methodology consultant and other researchers are not aware of this process
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics committees of Islamic Azad University, Dental Branch Tehran - Iran
Street address
Dental branch of Islamic Azad University of Tehran, 9th neyestan, Pasdaran, Tehran
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2023-05-14, 1402/02/24
Ethics committee reference number
IR.IAU.DENTAL.REC.1402.026
Health conditions studied
1
Description of health condition studied
Rhinoplasty
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Edema
Timepoint
7 day after surgery, 30 day after surgery
Method of measurement
Comparison of the distance between the two tips of the nose in the photos 7 and 30 days after the operation
2
Description
Echymosis
Timepoint
24 hours after surgery, 7 days after surgery, 30 days after surgery
Method of measurement
In the form of checking the distance between the eyelids in the photos before and after the operation and categorizing it as how much of the vertical line that passes through the eyelids and pupils is involved compared to the same before the operation.
3
Description
Pain
Timepoint
24 hours after surgery, 7 days after surgery, 30 days after surgery
Method of measurement
Using the Visual Analogue Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: They will begin the full course of photobiomodulation therapy (PBMT) immediately after surgery and continue it for 48 hours and 72 hours after surgery.
Category
Rehabilitation
2
Description
Control group: Without receiving a low level laser therapy
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
private practice
Full name of responsible person
Behnaz Poorian
Street address
next to Shariati Subway Station, Shariati
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 933 405 2223
Email
behnazpoorian@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Behnaz Poorian
Street address
Dental branch of Islamic Azad University of Tehran, 9th neyestan, Pasdaran, Tehran
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
behnazpoorian@gmail.com
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
1
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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Behnaz Poorian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental branch of Islamic Azad University of Tehran, 9th neyestan, Pasdaran, Tehran
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
behnazpoorian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Behnaz poorian
Position
Assistant Professor of Surgery Department, Azad Faculty of Dentistry, Tehran
Latest degree
Specialist
Other areas of specialty/work
Oral and maxio facial surgion
Street address
Dental branch of Islamic Azad University of Tehran, 9th neyestan, Pasdaran, Tehran
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
behnazpoorian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Behnaz poorian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental branch of Islamic Azad University of Tehran, 9th neyestan, Pasdaran, Tehran
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
benazpoorian@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 will be published after the completion of the trial and the conclusion
When the data will become available and for how long
After the trial is over, the results will be announced
To whom data/document is available
After the trial is over, the results will be announced
Under which criteria data/document could be used
The responsible author and the people conducting the research will be allowed to analyze and review the data, use the data for statistical analysis, or use the results to determine the volume of similar studies.
From where data/document is obtainable
Email to the corresponding author
email:
behnazpoorian@gmail.com
Address: Nistan 9th, Pasdaran, Tehran, Azad Islamic Faculty of Dentistry, Department of Oral, Maxillofacial Surgery
Postal code:
1946853314
Phone number:
009802122763460
What processes are involved for a request to access data/document
Calling and emailing the responsible author while specifying the reason for the data request along with determining how to use the results and specifying the type of analysis required for the requester.
If the requester is qualified, they will respond as soon as possible