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Effect of different photobiomodulation laser therapy in orthodontic pain reduction caused by elastic separator: randomized control trial

Protocol summary

Study aim
Effect of different photobiomodulation laser therapy in orthodontic pain reduction caused by elastic separator: randomized control trial
Design
This study is a randomized clinical trial with a parallel design and a control group. This randomized study will be performed on 24 patients. For randomization, online software for generating random numbers is used and participants are assigned to three intervention groups and one control group.
Settings and conduct
This study, which will be performed in the specialized dental clinic of Kermanshah University of Medical Sciences, is double-blind. In this double-blind study, researchers and patients are kept blind as to what type of treatment they will receive. Also, researchers and participants have no role in the process of randomization and assignment of intervention groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: In both jaws, all teeth are fully erupted by the second molar before treatment, and the second premolars, first and second molars are in contact, allowing 2 elastic separator in the mesial and distal of the first four molars. Exclusion criteria: Dependence on psychotropic drugs; History of anticonvulsant and antidepressant use; Chronic systemic diseases such as liver, lung, heart and kidney diseases etc...; History of neuropathic disorders, glossopharyngeal neuralgia, etc...; Diabetes and metabolic diseases
Intervention groups
In the first intervention group, a laser quadrant unit is turned on; Apply the laser for the first quarter of 120 seconds (60 seconds for each buccal or lumbar). In the second intervention group, 60 seconds lingual or palatal, and we reduce the time by half (that is, 30 seconds for each buccal or lumbar).In the third intervention group, a silent laser is used. Laser is not performed in the control group.
Main outcome variables
Pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130812014333N180
Registration date: 2022-02-08, 1400/11/19
Registration timing: prospective

Last update: 2022-02-08, 1400/11/19
Update count: 0
Registration date
2022-02-08, 1400/11/19
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-01, 1400/12/10
Expected recruitment end date
2022-05-31, 1401/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of different photobiomodulation laser therapy in orthodontic pain reduction caused by elastic separator: randomized control trial
Public title
Effect of different photobiomodulation laser therapy in orthodontic pain reduction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 30 years In both jaws, all teeth are fully erupted by the second molar before treatment, and the second premolars, first and second molars are in contact, allowing to put 2 elastic separators in the mesial and distal of the first four molars.
Exclusion criteria:
Dependence on psychotropic drugs History of taking anticonvulsants and antidepressants History of chronic systemic diseases such as liver, lung, heart and kidney diseases, etc. History of neuropathic disorders, glossopharyngeal neuralgia, etc.). Diabetes and metabolic diseases Infectious diseases, autoimmune diseases, immune defects, AIDS Pregnancy Symptoms of infection or periodontal disease History of tooth extraction from 2 weeks ago
Age
From 18 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
Generate random numbers using online software. Divided quadrants will be drawn on 24 sheets of paper (in the number of patients) and random numbers will be written on each quadrant. Then, each of the papers will be placed in an envelope. Each patient removes an envelope and based on that, the method of placement of elastic seperator will be done in each quadrant. The production of random numbers and allocation concealment will be done by an impartial observer.
Blinding (investigator's opinion)
Double blinded
Blinding description
Laser light with a wavelength of 940 nm is not visible to the human eye and no heat is generated. Therefore, both the patient and the operator were blind (on or off) when using the laser. The laser radiation will be performed by the dentist's assistant. The operator will not know which quadrant is treated with the laser on and which is treated with the laser off. However, complete blinding of the patient will not be possible, and only blinding for laser on or off will be possible.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2022-01-10, 1400/10/20
Ethics committee reference number
IR.KUMS.REC.1400.755

Health conditions studied

1

Description of health condition studied
Orthodontic Pain
ICD-10 code
Z51.8
ICD-10 code description
Encounter for other specified aftercare

Primary outcomes

1

Description
Pain
Timepoint
0, 1, 6, 12, 24, 48 hours after Separator placement
Method of measurement
Using Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
In the first intervention group, a laser quadrant unit is turned on; Apply the laser for the first quarter of 120 seconds (60 seconds for each buccal or lumbar). At each buccal or lingual surface, two points, one point 5 mm from the gingival margin and one point near the apex, the laser will be applied.
Category
Treatment - Other

2

Description
In the second intervention group, 60 seconds lingual or palatal, and we reduce the time by half (that is, 30 seconds for each groceries). At each buccal or lingual surface, two points, one point 5 mm from the gingival margin and one point near the apex, the laser will be applied.
Category
Treatment - Other

3

Description
In the third intervention group, a silent laser is used. At each buccal or lingual surface, two points, one point 5 mm from the gingival margin and one point near the apex, the laser will be applied.
Category
Treatment - Other

4

Description
Laser is not performed in the control group.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Specialized clinic of the School of Dentistry
Full name of responsible person
Dr. Amin Golshah
Street address
Faculty of Dentistry, Shariati Ave
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
amin.golshah@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Reza Khodarahmi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
rkhodarahmi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Amin Golshah
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Shariati Ave
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
amin.golshah@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Amin Golshah
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Shariati Ave
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
amin.golshah@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Amin Golshah
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Orthodontist
Street address
Faculty of Dentistry, Shariati Ave
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
amin.golshah@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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