The effectiveness of photobiomodulation compared to the elastomeric wafer on the perception of pain during debonding of metal orthodontic brackets
Design
This study is a one-blinded clinical trial. The study population will include all patients referring to the dental department of Kermanshah Dental School. 112 eligible patients will be selected conveniently and randomly assigned to four groups (three intervention groups and one control group).
Settings and conduct
This study, which will be conducted at the Kermanshah School of Dentistry, is one- blinded one, that patients will be kept blind to the allocation of study groups and treatment methods. At the beginning of the study, the amount of pain is recorded in a checklist
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having all permanent teeth; People who are undergoing fixed upper and lower jaw orthodontic treatment with a type of bracket; People who have finishing Archwire for at least two months
Exclusion criteria: Taking the drug periodically or taking the medication for 24 hours before the study; Have a cleft lip or cleft palate; Smokers or alcoholics; People who have taken antibiotics for the past 6 months or who have had periodontal treatment in the past year
Intervention groups
In the first intervention group, the elastomeric wafer of silicon wafers is used that placed between the arches and the patient is told to bite it firmly during debonding. In the second intervention group, they are treated with a low-power laser for at least 30 seconds to one minute before debonding, in which the laser is irradiated with 16 joules/ cm2 of energy in the buccal and palate region. In the third intervention group, the laser used is off.The control group will not receive any intervention.
Main outcome variables
Perception of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N149
Registration date:2020-04-26, 1399/02/07
Registration timing:prospective
Last update:2020-04-26, 1399/02/07
Update count:0
Registration date
2020-04-26, 1399/02/07
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
2020-04-28, 1399/02/09
Expected recruitment end date
2020-07-30, 1399/05/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of photobiomodulation compared to the elastomeric wafer on the perception of pain during debonding of metal orthodontic brackets
Public title
The effectiveness of photobiomodulation compared to the elastomeric wafer on the perception of pain during debonding of metal orthodontic brackets
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having all permanent teeth
People who are undergoing fixed upper and lower jaw orthodontic treatment with a type of bracket
People who have finishing Archwire for at least two months
Exclusion criteria:
Taking the drug periodically or taking the medication for 24 hours before the study
have a cleft lip or cleft palate
Smokers or alcoholics
People who have taken antibiotics for the past 6 months or who have had periodontal treatment in the past year
People with an index plate above 4
Age
From 13 years old to 21 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
Balanced block randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients have been kept blind about the allocation of study groups and treatment methods.
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
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2020-02-03, 1398/11/14
Ethics committee reference number
ir.kums.rec.1399.051
Health conditions studied
1
Description of health condition studied
metal orthodontic
ICD-10 code
Z46.4
ICD-10 code description
Encounter for fitting and adjustment of orthodontic device
Primary outcomes
1
Description
Perception of pain
Timepoint
At baseline, Immediately after debonding on each tooth and 1 week after removing the brackets
Method of measurement
Using visual scale of pain (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
In the first intervention group, the elastomeric wafer of silicon wafers is used that placed between the arches and the patient is told to bite it firmly during debonding.
Category
Treatment - Other
2
Description
In the second intervention group, they are treated with a low-power laser for at least 30 seconds to one minute before debonding, in which the laser is irradiated with 16 joules/ cm2 of energy in the buccal and palate region
Category
Treatment - Other
3
Description
In the third intervention group, the laser used is off.
Category
Treatment - Other
4
Description
The control group will not receive any intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry
Full name of responsible person
Ermia Rezae Shirazi
Street address
Shariati St., School of Dentistry
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3722 7151
Email
ermia.rezae@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@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
Ermia Rezaea Shirazi
Position
School of Dentistry
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Shariati St., School of Dentistry
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3722 7151
Email
ermia.rezae@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Amin Golshah
Position
Faculty member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Orthodontic
Street address
Shariati St., School of Dentistry
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
0098833729659
Email
amin.golshah@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Ermia Rezae Shirazi
Position
medical student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Shariati St., School of Dentistry
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3722 7151
Email
ermia.rezae@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
6months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 15-day period, the documents will be sent e-mail