The effect of LED 850 nm (intra oral ) on the perception of pain and speed rate of correction of the crowded Mandibular anterior teeth : A randomized controlled clinical trial
By conducting this research and determining the effects of using an intraoral LED device with light with a wavelength of 850 nm in accelerating the improvement of crowding of the mandibular anterior teeth and the amount of pain experienced if there are positive results, this technique can be used in clinical and Used to increase speed and reduce pain in orthodontic treatments
Design
Clinical trial of a two-way blind control group using stratified block randomization method was used
Settings and conduct
Patients are selected from the special clinic of Hamadan Dental School and the person analyzing the results is blind to which group the collected information belongs to.
Participants/Inclusion and exclusion criteria
inclusion : Patients aged 15-30 years require fixed orthodontic treatment
- Non-extraction treatment plan
Index of Dental Irregularities Larger Equals 2 mm and Less Equals 6 mm (Lower Anterior Crowding)
- Periodontal health and good oral hygiene (patients should not bleed from the gums during periodontal probe
exclusion :
Patients with periodontal problems, patients taking chronic drugs that affect bone metabolism (corticosteroids ...)
And if patients have a bracket failure and the bracket is not replaced within a week, they will be excluded from the study.
Intervention groups
In the test group,
The LED device with a wavelength of 850 nm is delivered to the patient to use it continuously for 5 minutes every day before going to bed. And charge the device once a week. In the control group, no radiation is performed.
Main outcome variables
rate of tooth movement
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120220009086N5
Registration date:2021-11-17, 1400/08/26
Registration timing:prospective
Last update:2021-11-17, 1400/08/26
Update count:0
Registration date
2021-11-17, 1400/08/26
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
2021-12-31, 1400/10/10
Expected recruitment end date
2022-03-30, 1401/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of LED 850 nm (intra oral ) on the perception of pain and speed rate of correction of the crowded Mandibular anterior teeth : A randomized controlled clinical trial
Public title
The effect of LED 850 nm (intra oral ) on the perception of pain and speed rate of correction of the crowded Mandibular anterior teeth : A randomized controlled clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with a grade of 2-6 mm with a small irregularity index are screened.
Exclusion criteria:
long-term consuming nonsteroidal anti inflammatory drugs a and hormonal supplements
poor periodontal health
Patients will be excluded from the study if the bracket fails and the bracket is not replaced within a week.
Age
From 15 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups of control and LED as a block randomization method.
Determines the order in which people are placed in groups. An envelope is selected and this person is placed in one of these groups
Blinding (investigator's opinion)
Double blinded
Blinding description
In this research, the person who collects the data, as well as the statistical advisor, are not aware of the allocation of groups, LED and controls
Placebo
Not 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
2021-10-18, 1400/07/26
Ethics committee reference number
IR.UMSHA.REC.1400.575
Health conditions studied
1
Description of health condition studied
Crowding of fully erupted teeth
ICD-10 code
M26.31
ICD-10 code description
Crowding of fully erupted teeth
Primary outcomes
1
Description
rate of tooth movement
Timepoint
At the beginning and end of the study
Method of measurement
study cast
2
Description
pain
Timepoint
two weeks after intervention
Method of measurement
modified McGill questionair
Secondary outcomes
empty
Intervention groups
1
Description
"Intervention group": All patients in the intervention group who have a fixed orthodontic appliance in their jaws are instructed to turn on the appliance for 5 minutes daily and put it in their mouth. This intraoral LED device is made of diodes with a wavelength of 850 nm, which are located in the area of the mandibular anterior teeth. And the patient turns it on and uses it by pressing a button embedded on the device. It should be noted that this device is delivered to the patient from the first session when the brackets and wires are placed on the anterior teeth of the mandible. These patients are visited on a monthly basis until the anterior crowding reaches below 1 mm, which is the end of use the device in this group.
Category
Treatment - Devices
2
Description
Control group: All patients with fixed orthodontic appliance in the mandible. These patients are not given any LED devices and are treated normally. These patients are visited monthly until the crowding in the anterior mandibular region reach below 1 mm.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan University of Medical Sciences
Full name of responsible person
Nasrin Farhadain
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
Saied 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
bashirian@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Hamadan 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
Yousef Ahmadpour
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
Email
chrika2020@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Yousef Ahmadpour
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
Email
chrika2020@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Yousef Ahmadpour
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
Email
chrika2020@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
Dental velocity data set can be shared in the light data group compared to the potential control group after unidentifiable individuals
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 chrika2020@gmail.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 yousef ahmadpour
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