Determination of the effectiveness of diode laser 940 nm in decreasing of oropharyngeal pain after bimaxillary orthognathic surgery
Design
A concealed, four blocks randomized, double-blinded, controlled clinical trial with 40 patients, enrolled between May 2019 and December 2019.
Settings and conduct
This clinical trial will be done in Hamadan Besat hospital.
Patients are allocated into two groups of control and intervention. Patients who have allocated in the intervention group will receive irradiation of 940 nm diode laser in the pharyngeal area immediately after Bimaxillary orthognathic surgery.
In the control group, no intervention will occur.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients who are candidates for bimaxillary orthognathic surgery
Exclusion criteriae: History of pain in the orofacial region before surgery; Taking analgesic, sedative, or corticosteroid before surgery; If surgery lasts more than 4 hours and less than 3 hours; If the intubation process repeats; If an anesthetic complication occurs; If a surgical complication occurs.
Intervention groups
Patients who have allocated in the intervention group will receive irradiation of 940 nm diode laser in the pharyngeal area immediately after Bimaxillary orthognathic surgery.
In the control group, no intervention will occur.
Main outcome variables
Pharyngeal region pain
Maxillary and/or mandibular regions pain
Pain during swallowing
Stridor
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120531009926N9
Registration date:2020-10-19, 1399/07/28
Registration timing:retrospective
Last update:2020-10-19, 1399/07/28
Update count:0
Registration date
2020-10-19, 1399/07/28
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
2019-05-10, 1398/02/20
Expected recruitment end date
2019-12-31, 1398/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determination of the Effectiveness of ِِDiode Laser 940 nm in Decreasing of Oropharyngeal Pain after Bimaxillary Orthognathic Surgery.
Public title
Effect of ِِDiode Laser 940 nm in Decreasing of Oropharyngeal Pain after Orthognathic Surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who are candidates for bimaxillary orthognathic surgery.
Exclusion criteria:
History of pain in the orofacial region before surgery
Taking analgesic, sedative, or corticosteroid before surgery
If surgery lasts more than 4 hours and less than 3 hours
If the intubation process repeats
If an anesthetic complication occurs
If a surgical complication occurs
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Each patient as a unit of randomization will be allocated in group A or B through four blocks. Concealment will be done by sealed envelope. The sequence of blocks will be determined with software.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
WHO International Clinical Trials Registry
Secondary trial Id
ACTRN1261600143646op " for ANZCTR
Registration date
2022-03-20, 1400/12/29
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan Medical Sciences University
Street address
Oral and Maxillofacial Surgery Department- Hamadan Medical Sciences University- Shahid Fahmideh Blv- Hamadan
City
Hamadan
Province
Hamadan
Postal code
65166852369
Approval date
2019-05-04, 1398/02/14
Ethics committee reference number
IR.UMSHA.REC.1398.096
Health conditions studied
1
Description of health condition studied
Pain in the oropharynx after simultaneous surgery of the two jaws
ICD-10 code
Code R07.0
ICD-10 code description
ICD-10-CM Diagnosis Code R07.0: Pain in throat
2
Description of health condition studied
Pain in the oropharynx after simultaneous surgery of the two jaws
ICD-10 code
Code R07.0
ICD-10 code description
ICD-10-CM Diagnosis Code R07.0: Pain in throat
Primary outcomes
1
Description
Oropharyngeal pain
Timepoint
ّFirst, second, third, fourth and fifth days after surgery
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Pain in maxillary and/or mandibular regions
Timepoint
ّFirst, second, third, fourth and fifth days after surgery
Method of measurement
Visual Analogue Scale
2
Description
Pain during swallowing
Timepoint
ّFirst, second, third, fourth and fifth days after surgery
Method of measurement
Visual Analogue Scale
3
Description
Stridor
Timepoint
ّFirst, second, third, fourth and fifth days after surgery
Method of measurement
Listening
Intervention groups
1
Description
Patients in the intervention group will be irradiated in the oropharyngeal region with 940 laser (Biolase, USA) immediately after surgery and before removal of the nasopharyngeal tube. Irradiation will be done continuously on all regions of oropharyngeal walls i.e posterior wall, lateral walls and posterior of the tongue. Irradiation will be fulfilled with a regular head and without contact to skin or mucosa. Output power is 100 w and spot size is 0.5 cm2. Irradiation time in each region is 20 s and power density is 0.2 w/ cm2.
Category
Treatment - Surgery
2
Description
Control group: In patients in the control group, after laser surgery of both jaws, no 940 diode laser radiation (Biolase, USA) is performed in the oropharynx.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Mohammad Reza Jamalpour
Street address
Shahid Beheshti street, Besat hospital
City
Hamadan
Province
Hamadan
Postal code
65166852369
Phone
+98 81 3832 3264
Email
jamalpour1972@gmial.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Reza Jamalpour
Street address
Pazhohesh street
City
Hamdan
Province
Hamadan
Postal code
65166852369
Phone
+98 81 3832 3264
Email
ghrrouhani@yahoo.co.uk
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
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
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Reza Jamalpour
Position
Associate professor of Oral and Maxillofacial surgery Department
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
pazhohesh street
City
Hamَdan
Province
Hamadan
Postal code
95166852369
Phone
+98 81 3832 3264
Email
jamalpour1972@gmail.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
Associate professor of Oral and Maxillofacial Surgery Department
Latest degree
Specialist
Other areas of specialty/work
Medical Education
Street address
Pazhohesh street
City
Hamadan
Province
Hamadan
Postal code
65166852369
Phone
+98 81 3832 3264
Email
jamalpour1972@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohammad Reza Jamalpour
Position
Associate Professor of Oral and Maxillofacial Surgery Department
Latest degree
Specialist
Other areas of specialty/work
Medical Education
Street address
Oral and maxillofacial surgery department, Dental faculty, Hamadan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
6517866589
Phone
+98 81 1826 0356
Fax
+98 81 1835 0126
Email
jamalpour@umsha.ac.ir
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
In the intervention group, a 940 nm diode laser is applied to the oropharynx after simultaneous surgery, and the pain in the oropharynx is measured after the operation.
When the data will become available and for how long
In the first to fifth days after surgery
To whom data/document is available
Doctors, assistants and students
Under which criteria data/document could be used
Merely the development of science and research
From where data/document is obtainable
surgery room
What processes are involved for a request to access data/document
1- Patient selection
2- Treatment plan
3- Anesthesia process
4- Surgery
5- Laser irradiation
6. Pain measurement