Evaluation of low-level laser therapy on controling gag reflex while taking periapical radiographs
Design
In this study, for phase 2 of the clinical trial, 26 patients referred to the School of Dentistry of the Islamic Azad University of Isfahan were selected based on the inclusion criteria.
For randomization, 13 patients referred on the even day were in the intervention group and 13 patients referred on the odd day were placed in the control group.
The study was performed as a single-blind study and patients did not know whether the laser was turned on or off.
Settings and conduct
Prior to low-power laser treatment, the pressure from intraoral imaging was restored by imaging film in the posterior region of the mouth.
Patients then marked the amount of nausea felt on the prepared vas line
After 1 minute and drinking half a glass of water, the first group of patients underwent low power laser irradiation at pc-6
The second group of patients were treated with a silent laser and the laser radiation was simulated
Participants/Inclusion and exclusion criteria
Existence of severe gag reflex while taking periapical radiographs based on the report of the radiology department of the dental school
Patients with facial malignancy, a history of seizures, or a thyroid tumor or pregnancy are not included in the study.
Intervention groups
The intervention group was treated with low power laser
In the control group, all conditions for laser treatment were simulated, but laser irradiation was not performed
In both groups, VAS was measured 3 times before and after irradiation and 2 months later
Main outcome variables
The amount of gag reflex felt that was marked on the VAS line
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201104049262N1
Registration date:2020-12-14, 1399/09/24
Registration timing:retrospective
Last update:2020-12-14, 1399/09/24
Update count:0
Registration date
2020-12-14, 1399/09/24
Registrant information
Name
amin jafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3621 5001
Email address
drjafariamin@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-06, 1398/09/15
Expected recruitment end date
2020-06-19, 1399/03/30
Actual recruitment start date
2019-12-22, 1398/10/01
Actual recruitment end date
2020-05-02, 1399/02/13
Trial completion date
2020-07-03, 1399/04/13
Scientific title
Effect of low-level laser therapy on controling gag reflex while taking periapical radiographs
Public title
Eeffect of low-level laser therapy on controling gag reflex while taking periapical radiographs
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Existence of severe gag reflex while taking periapical radiographs based on the report of the radiology department of the dental school
Exclusion criteria:
Pregnancy
Malignancy in the facial area
History of seizures
Thyroid tumor
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
26
Actual sample size reached:
26
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, 13 patients referred on the even day were in the intervention group and 13 patients referred on the odd day were placed in the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patient does not know if the laser is on or off
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan Azad University
Street address
University Blvd, Arqavanieh, Jey Street
City
Isfahan
Province
Isfehan
Postal code
81551-39998
Approval date
2019-10-05, 1398/07/13
Ethics committee reference number
IR.IAU.KHUISF.REC1398.204
Health conditions studied
1
Description of health condition studied
Gag reflex
ICD-10 code
R11.0
ICD-10 code description
Nausea
Primary outcomes
1
Description
Grade of Gag reflex
Timepoint
At the beginning of the visit-After treatment-2 month later
Method of measurement
VAS line
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Use of Behsaz gostar low level laser with 660 nm wave length and power of 3 j on pc6 point
Category
Treatment - Other
2
Description
Control group:Placebo , Off laser
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Azad University Dental Clinic
Full name of responsible person
Amin Jafari
Street address
University Blvd, Arqavanieh, Jey Street
City
Isfahan
Province
Isfehan
Postal code
81551-39998
Phone
+98 31 3535 4060
Email
info@khuisf.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The Islamic Azad University of Isfahan
Full name of responsible person
Majid Toghiani
Street address
University Blvd, Arqavanieh, Jey Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
info@khuisf.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The Islamic Azad University of Isfahan
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
The Islamic Azad University of Isfahan
Full name of responsible person
Amin Jafari
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No.15,Salimian Ave,Movahedinia Blvd,Tohid St
City
Isfahan
Province
Isfehan
Postal code
8173944674
Phone
+98 31 3621 5001
Email
drjafariamin@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The Islamic Azad University of Isfahan
Full name of responsible person
Amin Jafari
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No.15,Salimian Ave,Movahedinia Blvd,Tohid St
City
Isfahan
Province
Isfehan
Postal code
8173944674
Phone
+98 31 3621 5001
Email
drjafariamin@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The Islamic Azad University of Isfahan
Full name of responsible person
Amin Jafari
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No.15,Salimian Ave,Movahedinia Blvd,Tohid St
City
Isfahan
Province
Isfehan
Postal code
8173944674
Phone
+98 31 3621 5001
Email
drjafariamin@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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Marked VAS of the patient
When the data will become available and for how long
Start of the access from year2020
To whom data/document is available
All researchers from universities
Under which criteria data/document could be used
All analyses are allowed
From where data/document is obtainable
Amin Jafari
mail :drjafariamin@gmail.com
00989133066331
What processes are involved for a request to access data/document
Written request by email
Review the application within a week
Share information by email