Effect of low level laser therapy on pain control in initial stage of fixed orthodontic treatment
Design
Thirty-six patients were enrolled in this randomized, single-blind clinical trial. Using random allocation software, one quadrant in the patient's lower jaw was considered as the intervention group and the other quadrant in the same patient as the placebo group.
Settings and conduct
This single-blind study (patients) was performed orally in the orthodontics department of the School of Dentistry, Qazvin University of Medical Sciences, Iran. For patients with a pre-determined letter A, a laser is used in the right mandibular quadrant and the left mandibular quadrant is exposed to red light (placebo). In patients for whom the letter B was predetermined, the left quadrant of the mandible was irradiated and the right quadrant was irradiated with red light (placebo).
Participants/Inclusion and exclusion criteria
Admission: Patient with permanent dental system (premolars and permanent first and second molars have erupted); no history of taking analgesics in a recent week;
No systemic disease or chronic pain in the mouth and teeth;
Moderate and severe crowding based on Little’s irregularity index in mandible (4-9 mm)
No entry: taking painkillers after the initial archwire and laser radiation
Intervention groups
One quadrant in the patient's mandible was considered as the intervention group and the other quadrant as the placebo group. Laser irradiation was performed 5 minutes before the initial wiring and immediately after the initial wiring. On the intervention side, the laser was irradiated on the buccal and palatal surfaces for 15 seconds.
Main outcome variables
Pain during chewing after placing the initial wire for up to 7 days at the end of every 24 hours; Spontaneous pain after placing the initial wire for up to 7 days at the end of every 24 hours
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210404050846N1
Registration date:2021-12-21, 1400/09/30
Registration timing:retrospective
Last update:2021-12-21, 1400/09/30
Update count:0
Registration date
2021-12-21, 1400/09/30
Registrant information
Name
Rojin Khanmohammad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6640 3269
Email address
rojin.khanmohammad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-16, 1399/05/26
Expected recruitment end date
2021-06-20, 1400/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of low level laser therapy on pain control in initial stage of fixed orthodontic treatment
Public title
Effect of low level laser therapy on pain control in initial stage of fixed orthodontic treatment
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with permanent dentition
Patient without a history of taking painkillers in the last week
Patient with moderate and severe crowding based on Little’s irregularity index in mandible (4-9 mm)
Exclusion criteria:
Taking painkillers after the initial archwire and laser radiation
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
42
More than 1 sample in each individual
Number of samples in each individual:
2
One side of the mandible is considered as the intervention group and the other side is considered as the control group
Randomization (investigator's opinion)
Randomized
Randomization description
By allocation software random, one quadrant in the patient's mouth is randomly considered as the intervention group and the other quadrant as the placebo group
Blinding (investigator's opinion)
Single blinded
Blinding description
The study participant did not know which side of the jaw was exposed to the laser
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethice committee of Qazvin University of Medical Sciences
Street address
Qavin University of Medical Sciences,Shahid Bahonar Blv
City
Qazvin
Province
Qazvin
Postal code
3415759811
Approval date
2020-08-15, 1399/05/25
Ethics committee reference number
IR.QUMS.REC.1399.173
Health conditions studied
1
Description of health condition studied
Evaluation of low-intensity laser effect on orthodontic pain reduction after placement of first archwire
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Reduction of spontaneous pain and pain during chewing after placing the initial wire
Timepoint
Immediately after placing the initial wire and up to 1 week at the end of every 24 hours
Method of measurement
visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Right or left mandibular quadrant exposed to low intensity 940 nm laser with 100 mw power
Category
Treatment - Devices
2
Description
Control group: The right or left quadrant of the mandible, which is exposed only to low-intensity 940 nm laser red light
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Qazvin University of Medical Sciences
Full name of responsible person
Parviz Padisar
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Blv
City
Qazvin
Province
Qazvin
Postal code
3415759811
Phone
+98 28 3335 3061
Email
dentistry@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Parviz Padisar
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Blv
City
Qazvin
Province
Qazvin
Postal code
3415759811
Phone
+98 28 3335 3061
Email
dentistry@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Parviz Padisar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Orthodontics
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Blv
City
Qazvin
Province
Qazvin
Postal code
3415759811
Phone
+98 28 3335 3061
Email
drppadisar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Parviz Padisar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Orthodontics
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Blv
City
Qazvin
Province
Qazvin
Postal code
3415759811
Phone
+98 28 3335 3061
Email
drppadisar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Parviz Padisar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Orthodontics
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Blv
City
Qazvin
Province
Qazvin
Postal code
3415759811
Phone
+98 28 3335 3061
Email
drppadisar@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
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
The data will be available to researchers working in academia and in industry
Under which criteria data/document could be used
All scientific analyzes to advance science and technology are allowed on the data of this study.
From where data/document is obtainable
For any information, you can refer to this email address:
ppadisar@gmail.com
What processes are involved for a request to access data/document
To receive the documents, you can send your personal details and request to this email address:
ppadisar@gmail.com