Determine the effect of low power laser on pain control caused by elastomeric separators in orthodontic patients
Design
A clinical trial with a control group with parallel, two-blind, randomized groups
Settings and conduct
Place of study: The office of Dr. Seyed Amir Hossein Mirhashemi and The Dr. Seyed Reza Rasouli.
Method of study: In this double blind study, the patient and the observer are not informed on which study groups they are in. The data analyser is not involved in the laser procedure. The samples are randomly allocated to the study groups by means of block random method (blocks of size 4) using the Excel software. The last two samples are assigned to the study groups by means of simple randomization method.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 25 volunteer patients who are candidate for orthodontic treatment, both male and female, age between 18 and 30 years old.
Non-inclusion criteria: Having specific systemic disease, having specific mental problem, having specific dental or periodontal problem, using specific medication
Intervention groups
Intervention group : laser radiation in one quadrant of mouth, 810 nm diode laser will be radiated in 3 dose in three different times on patients. The patient's pain will be measured using the VAS method based on self-perception at different times and recorded the data and the amount of pain between the two groups are compared.
Control group : non-radiation laser in opposite side of the same jaw in the same person
The control group receives an inactive radiation as placebo. The method of measuring pain and radiation times is as same as intervention group.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190610043853N1
Registration date:2020-01-14, 1398/10/24
Registration timing:retrospective
Last update:2020-01-14, 1398/10/24
Update count:0
Registration date
2020-01-14, 1398/10/24
Registrant information
Name
Seyed Amirhossein Mirhashemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7793 4596
Email address
mirhashemi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-22, 1398/04/31
Expected recruitment end date
2019-08-22, 1398/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of low-level laser therapy on pain control caused by Elastomeric Separators in Orthodontic patients
Public title
Evaluation Of the effect of Low-level laser therapy on pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Twenty-five volunteer patients who are eligible for orthodontic treatment
Both male and female
Age between 18 and 30 years old
Exclusion criteria:
Having specific Systemic disease
Having specific Mental problem
Having specific Dental or Periodontal problem
Using specific Medication
Age
From 18 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Randomized
Randomization description
The samples were randomly allocated to the study groups by using block random method (blocks of size 4) using in Excel software. The last two samples were assigned to the study groups by simple randomization method.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the patient and the observer (data collector) are not informed about which study groups they are placed in. In regards to blinding, the patient in the non-radiation group receives a palcebo light, which is not a laser type and can be a light cure device. The person who does data analysis is not involved in the intervention procedure.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Faculty of Dentistry, Not reaching the Hakim highway, above the Atomic Energy Organization, End of the North Amirabad St, Kargar Ave.
City
Tehran
Province
Tehran
Postal code
1439955991
Approval date
2019-01-28, 1397/11/08
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1397.167
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
R52
ICD-10 code description
Pain, not elsewhere classified
Primary outcomes
1
Description
pain
Timepoint
0hours, 2 hours, 6hours, 24hours, 72hours and 5 days after laser
Method of measurement
visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: laser radiation in one quadrant of mouth The study is Split-mouth design so the intervention group and the control group are both in the same person. One side of patient (one half jaw) is as the intervention group and the other half as the control group which receiving placebo radiation. 24 hours before placing separators on the upper first molar, the first dose of low power 810 nm diode laser with a power of 0.3 W and energy of 3.75 J / cm2 and spot area = 0.8 cm2 and a continuous 10 seconds will be radiated on the location of radiation. The second radiation will be done at the time of placement and the third dose in 24 hours after the separators are placed. The patient's pain will be measured using the VAS method based on self-perception at 0, 2, 6, 24, 72 hours and 5 days after placement of separators, and recorded the data and the amount of pain between the two groups are compared.
Category
Prevention
2
Description
Control group: non-radiation laser in opposite side of the same jaw in the same person. The control group receives an inactive radiation as placebo at times like the intervention group. The method of measuring pain is as same as intervention group.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Seyed Amirhossein Mirhashemi Office
Full name of responsible person
Seyed AmirHossein Mirhashemi
Street address
Unit 23, Second floor, No. 107, Between Shirazi and Sheikh Bahai, Mulla Sadra St.
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8821 1640
Email
shiva_shahii@yahoo.com
2
Recruitment center
Name of recruitment center
Dr. Seyed Reza Rasouli
Full name of responsible person
Seyed Reza Rasouli
Street address
Unit 6- Second floor- No. 104- nwxt to the Ghobadian St.- Jordan St.
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8878 6343
Email
shiva_shahii@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahrayian
Street address
Tehran University of Medical Sciences, Faculty of Dentistry, before the Hakim highway, after the Atomic Energy Organization, at the end of the North Amirabad street, Kargar street.
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5950
Email
mirhashemi@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Seyed Amirhossein Mirhashemi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tehran University of Medical Sciences, Faculty of Dentistry, Not reaching the Hakim highway, above the Atomic Energy Organization, End of the North Amirabad St, Kargar Ave.
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5950
Email
mirhashemi@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed Amirhossein Mirhashemi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tehran University of Medical Sciences, Faculty of Dentistry, Not reaching the Hakim highway, above the Atomic Energy Organization, End of the North Amirabad St, Kargar Ave.
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5950
Email
mirhashemi@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed Amirhossein Mirhashemi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tehran University of Medical Sciences, Faculty of Dentistry, Not reaching the Hakim highway, above the Atomic Energy Organization, End of the North Amirabad St, Kargar Ave.
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8801 5950
Email
mirhashemi@tums.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
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 received after the receipt of the article resulting from the study can be shared
When the data will become available and for how long
Access 4 months after the publication of the paper resulting from the research
To whom data/document is available
Researchers working in academic and academic institutions
Under which criteria data/document could be used
All analyzes that do not need to identify samples and re-access them to data can be done
From where data/document is obtainable
Refer to the author of the article
What processes are involved for a request to access data/document
Perform correspondence with the submitter and send the information file