Investigating the effect of intra-oral LED device and low level laser therapy on the rate of orthodontic maxillary canine movement compared with control group: a randomized clinical trial
assessment of the effect of low level laser therapy & LED light on the rate of orthodontic maxillary canine movement
Design
randomized clinical trial with control group, three arm parallel , with blinded outcome assessor
Settings and conduct
Hamadan university of medical sciences, dental school
canine retraction with coil spring and investigating the effect of biolight and laser therapy on the rate of tooth movement
control group was blinded by a similar light device with a protective coating
Participants/Inclusion and exclusion criteria
Inclusion criteria:
orthodontic treatment plan that needs extraction of maxillary first premolar unilaterally or bilaterally, presence of maxillary canine, second premolar and first molar at the side of extraction of first premolar
exclusion criteria:
canine root dilacerations, long-term consuming nonstroidal anti inflammatory drugs and hormonal supplements, parafunctional habits, crossbite in canine area, poor periodontal health, pregnancy and lactating, history of previous fixed orthodontic treatment
Intervention groups
Intervention group number one: Low-level laser-therapy with Ga Al As laser with a wavelength of 810 nm four times in two months
Intervention group number 2: using biolight device 5 minutes a day throughout the study course
control group: using a similar light device with a protective coating four times in two months
Main outcome variables
rate of tooth movement, pain, tooth rotation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120220009086N4
Registration date:2019-06-01, 1398/03/11
Registration timing:prospective
Last update:2019-06-01, 1398/03/11
Update count:0
Registration date
2019-06-01, 1398/03/11
Registrant information
Name
Nasrin Farhadian
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1835 4017
Email address
farhadian@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-10, 1398/03/20
Expected recruitment end date
2020-01-20, 1398/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of intra-oral LED device and low level laser therapy on the rate of orthodontic maxillary canine movement compared with control group: a randomized clinical trial
Public title
Investigating the effect of intra-oral LED device and low level laser therapy on the rate of orthodontic maxillary canine movement compared with control group: a randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
orthodontic treatment plan that needs extraction of maxillary first premolar unilaterally or bilaterally
presence of maxillary canine, second premolar and first molar at the side of extraction of first premolar
Exclusion criteria:
canine root dilaceration
long-term consuming nonsteroidal anti inflammatory drugs a and hormonal supplements
parafunctional habits
crossbite in canine area
poor periodontal health
pregnancy and lactating
history of previous fixed orthodontic treatment
Age
From 15 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into 4 classes (gender-based and bracket-based) randomized block randomization methods. The size of the blocks is variable and is determined by the software.
This randomization is coordinated by an individual outside the research team in all cases.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients are blinded to intervention. Patients in the control group use a light-curing device with a protective coating in place of radiation, and radiation is done on days 0, 3, 30, and 60 according to the laser protocol.
In this research, the person who collects the data, as well as the statistical advisor, are not aware of the allocation of groups, LED lasers and controls.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Sciences
Street address
in front of Mardom park, Shahid Fahmideh street, Hamadan
City
hamadan
Province
Hamadan
Postal code
6517838741
Approval date
2019-05-06, 1398/02/16
Ethics committee reference number
IR.UMSHA.REC.1398.079
Health conditions studied
1
Description of health condition studied
Anomalies of tooth position of fully erupted teeth
ICD-10 code
M26.3
ICD-10 code description
Anomalies of tooth position of fully erupted tooth or teeth
Primary outcomes
1
Description
rate of tooth movement
Timepoint
at start of study, 1,2 and 3 months after intervention
Method of measurement
3D scanner and software
2
Description
pain
Timepoint
two weeks after intervention
Method of measurement
modified McGill questionair
3
Description
rotation of the canine
Timepoint
at start of study, 1,2 and 3 months after intervention
Method of measurement
3D scanner and software
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: Laser therapy is performed using the China Gigaa laser machine (dental diode laser Gigaa). The laser used is Ga Al As laser with a wavelength of 810 nm and a power of 100 μW. Diameter of laser tip in contact with tissue is 3.1 mm. Energy density is 4 Jules per square centimeter. Therapy is performed on days 0 and 3 and then on the day of spring activation (monthly) for 4 months (days 0, 3, 30 and 60) for 2 months. The laser is projected to 3 points at the buccal surface of the canine teeth, a point in the cervical, one point in the apical region, and one point in the middle region of root, at each point for 3 seconds. Similarly, 3 regions on the palatal surface of the canine also will be be irradiated.
Category
Treatment - Devices
2
Description
Intervention group2: The patients are trained in this group and they are advised to use the biolight device for 5 minutes everyday for two months. This intra-oral LED device is made up of 640 nm wavelength and 20 mw / cm2 power diodes. The device consists of 2 pairs of LEDs on the right or left that are located in the canine area of the tooth space.
Category
Treatment - Devices
3
Description
Control group: For patients in the control group, a similar light device with a protective coating is used , and radiation is performed on days 0, 3, 30 and 60 according to the laser protocol.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan university of medical sciences
Full name of responsible person
Amirfarhang Miresmaeili
Street address
in front of Mardom park, Shahid Fahmideh street, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838741
Phone
+98 81 3838 1059
Fax
+98 81 3838 1085
Email
dentistry@umsha.ac.ir
Web page address
http://dentistry.umsha.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeid Bashirian
Street address
in front of Mardom park, Shahid Fahmideh street, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838741
Phone
+98 81 3838 1059
Fax
+98 81 3838 1085
Email
dentistry@umsha.ac.ir
Web page address
http://dentistry.umsha.ac.ir/
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
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
Mozhde Borjali
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
in front of Mardom park, Shahid Fahmideh street, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838741
Phone
+98 81 3838 1059
Fax
+98 81 3838 1085
Email
mozhde.borjali@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mozhde Borjali
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
in front of Mardom park, Shahid Fahmideh street, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838741
Phone
+98 81 3838 1059
Fax
+98 81 3838 1085
Email
mozhde.borjali@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mozhde Borjali
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
in front of Mardom park, Shahid Fahmideh street, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838741
Phone
+98 81 3838 1085
Fax
+98 81 3838 1085
Email
mozhde.borjali@yahoo.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
laser versus LED light groups rate of tooth movement data set
all collected deidentified IPD are to be shared
When the data will become available and for how long
starting 6 months after publication, the data will be available for 20 years
To whom data/document is available
the data will be available only for people working in academic institutions
Under which criteria data/document could be used
no types of analyses on the documents is allowed
From where data/document is obtainable
the preferred way of communication is via email
mozhde.borjali@yahoo.com
the postal address is, Hamadan dental school, in front of Mardom park, Shahid Fahmideh street, Hamadan
telephone number is +98 81 3838 1059
fax number is +98 81 3838 1085
the contact person is Mozhde Borjali
What processes are involved for a request to access data/document
the requests will be discussed and the data would be available in three months