Evaluation of the effect of Diode 940 nm on post-rhinoplasty nasal tip edema after 2 months
Design
A concealed with sealed Envelope, randomized by quadri-blocks, blinded, sham controled clinical trial with a paraallel group design of 30 patients.
Settings and conduct
Patients will be assigned to study and control groups via four blocks. Surgical technique in both groups is open( Transcolumellar incision+Bilateral marginal incision). All surgeries will be performed by a oromaxillofacial surgeon. 940 nm diode laser is continuously exposed to eight ereas of nose, around of the nose, two nostrils and Submandibular and jugular-digastric areas. radiations will be performed by the thesis student. Angle measurements will be done by Adobe Photoshop from photographies. The device will be turned off in control group and the handpiece will be moved on nose and nostrils. A headphone will be put on both groups of patients during radiation.
Participants/Inclusion and exclusion criteria
This study will be conducted on patient who is a primary rhinoplasty candidate and is in ASA I grade (with no history of systemic disease); Patients with nasal and lip cleft, patients undergoing drug therapy, patients with a history of previous nasal surgery, and patients who do not take post-operative photographies will be excluded.
Intervention groups
940nm diod laser( Biolase, USA) will be radiated on patient's face; on eight areas of the nose and around it and also on submandibular and jugular-digastric areas. Laser radiation will be continuous. ray will be exposed to each area for 91 seconds. In the control group (Sham laser group), the device will be turned off and the handpiece will be moved on the nose and nasal holes. Meanwhile, at the time of laser and sham laser radiation, headphones will be placed on the ears of the patient.
Main outcome variables
reduction of nose tip edema; no reduction of nose tip edema
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181216041994N1
Registration date:2019-03-20, 1397/12/29
Registration timing:prospective
Last update:2019-03-20, 1397/12/29
Update count:0
Registration date
2019-03-20, 1397/12/29
Registrant information
Name
Hanie Tavasoliara
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3822 6487
Email address
hanie_tavasoliara@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-09, 1398/01/20
Expected recruitment end date
2019-06-10, 1398/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Diode 940 nm laser on reduction of post-rhinoplasty nasal tip edema
Public title
Evaluation of the effect of Diode 940 nm on reduction of nasal tip edema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
primary rhinoplasty candidate
ASA I patients ( no systemic disease)
Exclusion criteria:
Patients with lip and nasal cleft
Patients under pharmaceutical treatment
Patients with the history of rhinoplasty
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly devided into Intervention and control group via quadri-blocks. concealment will be done through Sealed Envelope
Blinding (investigator's opinion)
Single blinded
Blinding description
In the control group (Sham laser group), the device will be turned off and the handpiece will be moved on the nose and nasal holes. Meanwhile, at the time of laser and sham laser radiation, headphones will be placed on the ears of the patients.
Placebo
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
Hamedan university of medical sciences, Shahid Fahmideh Blvd., Hamedan Town
City
Hamedan
Province
Hamadan
Postal code
6517838677
Approval date
2019-02-28, 1397/12/09
Ethics committee reference number
IR.UMSHA.REC.1397.877
Health conditions studied
1
Description of health condition studied
nose tip edema after rhinoplasty
ICD-10 code
R60.0
ICD-10 code description
Localized edema
Primary outcomes
1
Description
nose tip edema
Timepoint
8 days after surgery; every week until 2 months after surgery
Method of measurement
photoshop software
Secondary outcomes
1
Description
nose tip projection
Timepoint
8 days after surgery; every week until 2 months after surgery
Method of measurement
photoshop
2
Description
supratip depression
Timepoint
8 days after surgery; every week until 2 months after surgery
Method of measurement
photoshop
3
Description
amount of Columella exposure
Timepoint
8 days after surgery; every week until 2 months after surgery
Method of measurement
photoshop
4
Description
nose tip retraction
Timepoint
8 days after surgery; every week until 2 months after surgery
Method of measurement
photoshop
5
Description
nosal width in middle of Columella
Timepoint
8 days after surgery; every week until 2 months after surgery
Method of measurement
photoshop
6
Description
nasal width in pinnacle of nostrils
Timepoint
8 days after surgery; every week until 2 months after surgery
Method of measurement
photoshop
7
Description
nasal width between pinnacle of nostrils and nose tip
Timepoint
8 days after surgery; every week until 2 months after surgery
Method of measurement
photoshop
Intervention groups
1
Description
Intervention group: 940nm Diod laser( Biolase,USA) is radiated to patient's face on eight zones of nose and nasal nostrils and also on Submandibular and jugular-digastric. Laser radiation will be continuous. Energy density: 4 J/cm2, spot size: 2.27 cm2, outputpower: 0.1 mW and the ray is radiated to each zone for 91 seconds. energy in each zone is 9.08 j. power density: 44 mW/cm2
Category
Treatment - Devices
2
Description
Control group: In control group( Sham laser group) the device will be turned off and the handpiece will be moved on nose and nasal nostrils.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat hospital
Full name of responsible person
Dr Mohammadreza Jamalpour
Street address
No 20, Mazdaghine Street, Shahid Beheshti Street
City
Hamedan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3265 0030
Email
jamalpour1972@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellors of Research and Technology, Hamedan University of Medical Sciences
Full name of responsible person
Maryam Asgarinia
Street address
No. 14, Shahid Fahmideh street
City
Hamedan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 1086
Email
jamalpour1972@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellors of Research and Technology, 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
Hanie Tavasoliara
Position
University student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No 29, third Siahrang alley, Fatemie street, Saeedie Blvd., Hamedan Town
City
Hamedan
Province
Hamadan
Postal code
6516945381
Phone
+98 81 3822 6487
Fax
Email
Hanie_tavasoliara@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Reza Jamalpour
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
جراحی فک و صورت
Street address
Hamedan university of medical scinces, Shahid Fahmideh Blvd., Hamedan Town
City
Hamedan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 1059
Email
jamalpour1972@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Hanie Tavasoliara
Position
University student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No 29, third Siahrang Alley, Fatemie Street, Saeedie Blvd., Hamedan Town
City
Hamedan
Province
Hamadan
Postal code
6516945381
Phone
+98 81 3822 6487
Fax
Email
Hanie_tavasoliara@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available