The effect of photobiomodulation on the perception of pain during orthodontic interproximal tooth reduction; a double-blinded randomized controlled trial
The effect of photobiomodulation on the perception of pain during orthodontic interproximal tooth reduction
Design
This is a randomized, double-blind clinical trial with a parallel design and a control group. Phase 2-3, this randomized study, will be conducted on 24 eligible patients. For randomization, simple random is used, and the participants are assigned to three groups (one intervention group and two control groups).
Settings and conduct
This study, which will be conducted in the clinic of the Faculty of Dentistry in Kermanshah, is a double-blinded. The patients and the operator are blinded to whether the laser light is on or off. Interproximal stripping will be done manually by an orthodontist using manual abrasive strips for all patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consent; Bolton dispute; Slight crowding in the lower incisor area; Mild misalignment between arches and a need for interproximal stripping; Centerline difference
Exclusion criteria: Patients with removable orthodontic appliances; History of taking anticonvulsant and antidepressant drugs; Active herpes simplex infection in the mouth (simplex and zoster); History of temporomandibular arthritis
Intervention groups
The intervention group includes orthodontic candidate patients who will receive low-power laser therapy at least 3 minutes before interproximal stripping, a diode laser (Epi X, Biolase, USA) with a wave length of 940 nm is used, and laser radiation with an energy of 32 J/cm2 (180 seconds) ) will be done to the labial and lingual areas. The first control group includes orthodontic candidate patients who will be subjected to off-laser. The second control group includes orthodontic candidate patients who will undergo interproximal stripping without using a laser.
Main outcome variables
The Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N192
Registration date:2023-01-18, 1401/10/28
Registration timing:registered_while_recruiting
Last update:2023-01-18, 1401/10/28
Update count:0
Registration date
2023-01-18, 1401/10/28
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
2023-01-10, 1401/10/20
Expected recruitment end date
2023-05-10, 1402/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of photobiomodulation on the perception of pain during orthodontic interproximal tooth reduction; a double-blinded randomized controlled trial
Public title
The effect of photobiomodulation on the perception of pain during orthodontic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent
Bolton dispute
Slight crowding in the lower incisor area
Mild misalignment between arches and a need for interproximal stripping
Centerline difference
Exclusion criteria:
Patients with removable orthodontic appliances
History of taking anticonvulsant and antidepressant drugs
Active herpes simplex infection in the mouth (simplex and zoster)
History of temporomandibular arthritis
Age
From 18 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Using the simple random method. The names of the participants are written on the card. The cards are put into a box that cannot be seen from outside. One of the colleagues of the plan is asked to remove one card from the container at a time. The names of the 8 cards that are selected first are placed in the first intervention group, the second 8 selected cards are placed in the first control group, and the remaining 8 in the second control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
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
2022-10-11, 1401/07/19
Ethics committee reference number
IR.KUMS.REC.1401.344
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
The pain
Timepoint
The first, second, fourth and seventh days after laser radiation
Method of measurement
Using a visual pain scale
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will receive low-power laser therapy at least 3 minutes before interproximal stripping, a diode laser (Epi X, Biolase, USA) with a wavelength of 940 nm is used, and laser radiation with an energy of 32 J/cm2 (180 seconds) ) will be done to the labial and lingual areas.
Category
Treatment - Other
2
Description
The first control group will be subjected to off-laser.
Category
Treatment - Other
3
Description
The second control group will undergo interproximal stripping without any use of a laser.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental faculty clinic
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. Cyrus Jalili
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
cjalili@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
Amin Golshah
Position
Member of the teaching faculty 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
Member of the teaching faculty 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
Member of the teaching faculty 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
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