This study was carried out to answer the question whether low - level laser therapy can affect the acceleration of canine movement during a fixed orthodontic movement.
If the response is positive, the length of orthodontic treatment will decrease and thus the bad effects of long - term treatment such as gingival recession, root resorption, tooth decay will be reduced.
Design
Randomized clinical trial with intervention and placebo group and split mouth design, parallel group and single blind. Randomization was done by flipping a coin with 15 patients.
Settings and conduct
The study will evaluate adult patients who receive fixed orthodontic treatment and need bilateral extractions of maxillary first premolars. After alignment and in canine retraction phase, low level laser therapy will apply in 3weeks intervals. Results will evaluate after 12weeks by intra oral scanner.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age above 18, presence of all permanent maxillary teeth except third molar,requiring of maxillary premolar extraction at both sides, the possibility of ligating the brackets to all maxillary teeth, absence of any systemic disease, good oral hygiene.
Exclusion criteria: severe dental displacement ( such as ectopic canine ) and patients who report taking drug during treatment, any problem with the spring, brackets debonding, irregular visits.
Intervention groups
1) Intervention group: low level laser irradiation canine area at intervention side
2) control group: non irradiation at control side
Main outcome variables
Rate of canine movement
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221018056237N1
Registration date:2022-11-02, 1401/08/11
Registration timing:prospective
Last update:2022-11-02, 1401/08/11
Update count:0
Registration date
2022-11-02, 1401/08/11
Registrant information
Name
Fatemeh Shirini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4411 0127
Email address
aisashirini@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-22, 1401/09/01
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of low level laser therapy at canine movement in fixed orthodontic treatment among adult
Public title
The effect of low level laser therapy in fixed orthodontic treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient should be older than 18 years
Patient should have all permanent teeth (except third molar)
There should be a possibility of placing brackets to all of the maxillary teeth
Requiring extraction of premolars bilaterally in the maxillary arch
Patient should have good oral hygiene
Exclusion criteria:
History of orthodontic treatment
Presence of systemic disease
Severe dental displacement
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
15
More than 1 sample in each individual
Number of samples in each individual:
2
One side of the mouth is the intervention group and laser radiation will be done and the other side of the mouth is the control group.
Randomization (investigator's opinion)
Randomized
Randomization description
The design of the study is split mouth and the side of the intervention ( laser radiation) and control
side ( placebo ) in the mouth will be determined by simple randomization .The random sequence
will be carried out by an independent person by flipping the coin .The side of the radiation and the
non - radiation for each patient will be placed in a letter and will be opened directly before the laser
irradiation starts .
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants ( patients ) are completely unaware which side, laser will be radiated and
which side is placebo.
Placebo
Used
Assignment
Parallel
Other design features
split mouth design
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of the Dental branch of Tehran Azad Islamic University
Street address
No9, Dental branch of Islamic Azad University, 9th Neyestan, Pasdaran Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1946853314
Approval date
2022-10-03, 1401/07/11
Ethics committee reference number
IR.IAU.DENTAL.REC.1401.080
Health conditions studied
1
Description of health condition studied
Low level laser therapy and canine movement during fixed orthodontic treatment
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Rate of canine movement
Timepoint
T0 (before laser therapy), after 6weeks, after 9weeks, after 12 weeks
Method of measurement
Intra oral scanner
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After alignment of teeth, in retraction phase, at intervention side, irradiation of GA-AL-AS diode laser (Ilase, USA) will be done with 3 weeks intervals ( for 9weeks). Laser will operate at 940 nm wavelength in a continuous mode. Irradiation will deliver through the 0.04 cm2 diameter optical fiber tip in light contact with the oral mucosa.( 5 points at buccal and 5 points at palatal). The target area will irradiate on these sites, for 3seconds in each point. ( Mesial and distal to the cervical area of the canine, Mesial and distal to the apical area of the canine, One point in the middle of the root). The power output set at 100 mW for 3 sec at each point made the cumulative of 7.5 J/cm2 energy density.
Category
Treatment - Devices
2
Description
Control group: After alignment phase laser will not irradiate at placebo side and just red marker of laser will be on.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental branch of Islamic Azad University Tehran Medical Sciences
Full name of responsible person
Fatemeh Shirini
Street address
No.9, dental brcanch of Tehran Islamic Azad University, 9th Neyestan, Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
aisashirini@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Arash Azizi
Street address
No.9, dental brcanch of Tehran Islamic Azad University, 9th Neyestan, Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
aisashirini@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Fatemeh Shirini
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No1, west 16th, South Vahid Ave, Sazman barnameh Ave, Hejazi Blv, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1484986517
Phone
+98 21 4411 0127
Fax
Email
aisashirini@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Shirini
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No1, west 16th, South Vahid Ave, Sazman barnameh Ave, Hejazi Blv, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1484986517
Phone
+98 21 4411 0127
Fax
Email
aisashirini@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Shirini
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No1, west 16th, South Vahid Ave, Sazman barnameh Ave, Hejazi Blv, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1484986517
Phone
+98 21 4411 0127
Fax
Email
aisashirini@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
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
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The total data will be shared. (all collected unidentified IPD)
When the data will become available and for how long
Access will start from 2023 .
To whom data/document is available
For researchers who working at academic institutions.
Under which criteria data/document could be used
In order to use in the scientific research, data can be used.