Evaluation of low level laser therapy on acceleration of anterior teeth movement in the first phase of orthodontic treatment among patients referred to orthodontic department of dentistry Faculty
Use a non-invasive method to accelerate tooth movement and shorten orthodontic treatment time
Design
Clinical trial with control group with parallel groups, one-way blind, third phase of the trial, randomized on 14 patients by block randomization method with 4 blocks.
Settings and conduct
This study is performed on patients undergoing orthodontic treatment at the School of Dentistry. The anterior teeth of one side of the patient are irradiated with a low-level diode laser, which emits an infrared wave with a wavelength of 810 nm. A laser tip is placed on the other side of the patient's mouth, but laser radiation is not performed. The patient does not know which side is irradiated.
Laser therapy is performed in each session until the anterior teeth are fully aligned. The final result is evaluated as the difference in the time of alignment of the anterior teeth on both sides.
Participants/Inclusion and exclusion criteria
Patients with permanent teeth in the age range of 15 to 30 years who need comprehensive orthodontic treatment. With a degree of dental malformation, Little is larger than 4 mm and less than 8 mm, and the treatment plan is without tooth extraction.
Patients who are systemically healthy. They have good oral health and healthy periodontal status.
Exclsuion criteria: Uncontrolled periodontal problems with bone resorption
Gingival resorption greater than 2 mm
Smoker
Bone metabolism is altered as a result of illness or medication
Physical or mental disability
Pregnancy
Intervention groups
1- Intervention group: One side of the patient, right or left, is randomly selected as the experimental group and is regularly irradiated with laser during orthodontic treatment.
2- Control group: A laser tip is placed on the other side of the patient's mouth, but laser radiation is not performed.
Main outcome variables
Accelerate tooth movement in orthodontic treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211203053265N1
Registration date:2022-02-26, 1400/12/07
Registration timing:prospective
Last update:2022-02-26, 1400/12/07
Update count:0
Registration date
2022-02-26, 1400/12/07
Registrant information
Name
Mahboobe Hoseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3373 7193
Email address
mahboobe.hoseini67@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-03, 1401/01/14
Expected recruitment end date
2022-10-22, 1401/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of low level laser therapy on acceleration of anterior teeth movement in the first phase of orthodontic treatment among patients referred to orthodontic department of dentistry Faculty
Public title
Evaluation of low level laser therapy on acceleration of anterior teeth movement in the first phase of orthodontic treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with permanent dentition aged between 15 to 30 years old that need orthodontic treatment.
Little Irregularity Index score between 4 to 8 millimeters
Healthy systemic patients
Good oral hygiene and healthy periodontal status
Exclusion criteria:
Uncontrolled periodontal problems with bone loss
Gum recession more than 2 millimeters
Smoking
Altered bone metabolism due to disease or drug use
Physical or mental disability
Pregnancy
Age
From 15 years old to 30 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
28
More than 1 sample in each individual
Number of samples in each individual:
2
The patient's central, lateral, and canine teeth are on the right or left side
Randomization (investigator's opinion)
Randomized
Randomization description
To randomize the treatment between the left and right mouth, a block randomization method with 4 blocks will be used (block size: 4, actual list length: 14). Considering the time of entry into the study, group A indicates receiving laser treatment on the right side and group B indicates receiving laser treatment on the left side of the mouth and the other side is considered as control. It is an individual randomization unit. Randomization tool is SAS statistical software version 9.
How to build a randomization sequence:
Block ID, block size, sequence within the block, treatment
for example:
• 1, 4, 1, Group B.
• 1, 4, 2, Group A.
....
Blinding (investigator's opinion)
Single blinded
Blinding description
patients are unaware about the test group because tip of the device will be put on the control side but radiation will not be done.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Ahmadzade Ave, Amini Alley, 107 apartment
City
Rasht
Province
Guilan
Postal code
4174734681
Approval date
2021-11-25, 1400/09/04
Ethics committee reference number
IR.GUMS.REC.1400.407
Health conditions studied
1
Description of health condition studied
Anomalies of tooth position
ICD-10 code
K07.3
ICD-10 code description
K07.3 Anomalies of tooth position
Primary outcomes
1
Description
Accelerate tooth movement in orthodontic treatment
Timepoint
At the end of the time the anterior teeth become aligned
Method of measurement
Number of days for the patient's teeth to be aligned
Secondary outcomes
1
Description
Reduce pain during orthodontic treatment
Timepoint
After each replacement of the archwire. Normally 3 times during treatment
Method of measurement
After each archwire replacement, each patient's pain is measured on a visual analogue scale 24 hours after the visit.
Intervention groups
1
Description
Intervention group: Central, lateral and canine teeth on one side of the patient are exposed to laser radiation. The laser in this study is a low-power gallium arsenide diode (model THOR LX2) that emits an infrared wave with a wavelength of 810 nm. The radiation is continuous with a power of 200 mW. Laser therapy is repeated on days 3, 7, 14 and every month to achieve complete alignment and leveling of the anterior teeth.
Category
Treatment - Other
2
Description
Control group: Central, lateral and canine teeth on the opposite side of the patient. To blind the tip of the laser device is placed on the teeth of this part, but laser radiation is not done.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
dentistry faculty of Guilan university of medical science
Full name of responsible person
Faeghe Gholinia
Street address
Lacan 2 km Saravan Road to Fouman, School of Dentistry
City
Rasht
Province
Guilan
Postal code
4188794755
Phone
+98 13 3348 6406
Email
dental@gums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Faeghe Gholinia
Street address
Faculty of Dentistry, Guilan University of Medical Sciences, Ring Fooman, Lacan Road
City
Rasht
Province
Guilan
Postal code
4194173774
Phone
+98 13 1326 3622
Email
f.gholinia@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Faeghe Gholinia
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Guilan University of Medical Sciences, Ring Fooman, Lacan Road
City
Rasht
Province
Guilan
Postal code
4188794755
Phone
+98 13 1326 3622
Email
f.gholinia@gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Faeghe Gholinia
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Guilan University of Medical Sciences, Ring Fooman, Lacan Road
City
Rasht
Province
Guilan
Postal code
4194173774
Phone
+98 13 1326 3622
Email
f.gholinia@gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Faeghe Gholinia
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Guilan University of Medical Sciences, Ring Fooman, Lacan Road
City
Rasht
Province
Guilan
Postal code
4194173774
Phone
+9813263622
Email
f.gholinia@gums.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
Undecided - It is not yet known if there will be 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
Evaluation of low level laser therapy on acceleration of anterior teeth movement in the first phase of orthodontic treatment among patients referred to orthodontic department of Guilan dentistry Faculty
When the data will become available and for how long
Start the access period 6 months after publishing the results
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Researchers working in academic institutions
From where data/document is obtainable
gholiniaf@gmail.com
What processes are involved for a request to access data/document