Protocol summary

Study aim
The effect of low level laser on tooth sensivity after orthodontic resection.
Design
This study is a randomized clinical trial with a parallel design and a control group. This randomized study will be performed on 28 patients. For randomization, Random numbers will be generated online and participants are assigned to two 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.At each point, the surface of the mucosa dries, and the laser probe, which is covered with disposable nylon foam, adheres vertically to the mucosa and presses until the mucosa surface is partially white.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 18 to 22 years; Informed consent; People who needed orthodontics. 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
Intervention groups
The first intervention group will receive a 200-wavelength laser (at each buccal or lingual surface, two dots, one 5 mm from the gingival margin and one point near the apex, apply the laser probe for 4 seconds). The second intervention group will receive a laser with a wavelength of 300 (in each buccal or lingual surface, two points, one at a distance of 5 mm from the gingival margin and one point near the apex, the laser probe is applied for 4 seconds). The control group will not receive a laser.
Main outcome variables
Tooth sensitivity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130812014333N181
Registration date: 2022-02-09, 1400/11/20
Registration timing: prospective

Last update: 2022-02-09, 1400/11/20
Update count: 0
Registration date
2022-02-09, 1400/11/20
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
2022-02-28, 1400/12/09
Expected recruitment end date
2022-05-30, 1401/03/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of low level laser on tooth sensitivity after orthodontic resection
Public title
The effect of low level laser on tooth sensitivity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 to 22 years Informed consent People who needed orthodontics.
Exclusion criteria:
Dependence on psychotropic drugs and narcotics 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
Age
From 18 years old to 22 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 28
Randomization (investigator's opinion)
Randomized
Randomization description
Production of random numbers online in Kitset Website. Divided quadrants will be drawn on 28 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.1400.756

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
Tooth sensitivity
Timepoint
6 days after the start of the intervention
Method of measurement
Inspection

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group will receive a 200-wavelength laser (at each buccal or lingual surface, two dots, one 5 mm from the gingival margin and one point near the apex, apply the laser probe for 4 seconds).
Category
Treatment - Other

2

Description
The second intervention group will receive a laser with a wavelength of 300 (in each buccal or lingual surface, two points, one at a distance of 5 mm from the gingival margin and one point near the apex, the laser probe is applied for 4 seconds).
Category
Treatment - Other

3

Description
The control group will not receive a laser.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Specialized clinic of the School of Dentistry
Full name of responsible person
Dr. Navid Razaei
Street address
Faculty of Dentistry, Shariati Ave
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
navidrezaie24@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. Navid Razaei
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
navidrezaie24@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Navid Razaei
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
navidrezaie24@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Navid Razaei
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
navidrezaie24@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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