Clinical trial with control group (opposite side of the individual) with parallel groups of 26 people. In this study, no randomization is chosen and all individuals with Gag reflex are being involved in the study. Each person receives a low-level laser at right side of the body and on the left side, colored laser light as a placebo is given to the participants
Settings and conduct
This clinical trial study was performed on 26 dentist patients aged 20 to 40 years who were referred to the dental radiology center using XCP
Participants/Inclusion and exclusion criteria
Patients between the age of 20 and 40 who are referred for intraoral radiographs experience nausea / health / consent to participate in the study
Intervention groups
In this study, 26 people who need to have a dental radiography and feel gag reflex will be involved. After obtaining written and informed consent, each person will be compared with himself, so that this study is based on 26 people who have a gag reflex and have referred to the radiography department of the dental school.Initially, the GAG reflex is measured before the intervention. Low level diode laser (Elexxion) with continuous wavelength of 810 nm and 400 µm fiber is being utilized on the right side of the body (with a diameter of 1.1 cm) with a power of 300 mW for 60 seconds. It will be used at the PC6 point and then dental radiography will be taken, the severity of nausea (CGP) and the Gag reflex are measured. In the next step, on the left side of the body, only the colored laser light is used as a placebo and a dental radiography is taken and the Gag reflex is determined again.
Main outcome variables
Gag reflex
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191008045033N1
Registration date:2021-01-30, 1399/11/11
Registration timing:retrospective
Last update:2021-01-30, 1399/11/11
Update count:0
Registration date
2021-01-30, 1399/11/11
Registrant information
Name
mahya farsadeghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3345 0571
Email address
mahyafarsadeghi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-28, 1398/06/06
Expected recruitment end date
2019-09-28, 1398/07/06
Actual recruitment start date
2019-09-01, 1398/06/10
Actual recruitment end date
2019-10-05, 1398/07/13
Trial completion date
2019-10-12, 1398/07/20
Scientific title
Efficacy of low-level Diode laser therapy (810nm) in controlling the gag reflex in dental radiography
Public title
Efficacy of low-level Diode laser therapy (810nm) in controlling the gag reflex in dental radiography
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who require dental radiography
Exclusion criteria:
All patients who had normal Gag reflex
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
26
Actual sample size reached:
26
Randomization (investigator's opinion)
N/A
Randomization description
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
Zanjan University of Medical Sciences
Street address
Azadi Ave.,Jomhoriye Eslami Blvd.,Zanjan town
City
Zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2018-08-28, 1397/06/06
Ethics committee reference number
IR.ZUMS.REC.1897.78
Health conditions studied
1
Description of health condition studied
Gag reflex
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Gag reflex
Timepoint
Before & after laser therapy
Method of measurement
Presence or severity of gag reflex
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: In this study, 26 people who need to take a dental radiography and feel gag reflex will be involved. After obtaining informed consent each person will be compared to himself. Continuous wavelength of 810 nm diode laser with 400-µm fiber is placed on the target site (with a diameter of 1.1 cm) and with a power of 300 mW will be projected on the PC6 point for 60 seconds.
Category
Treatment - Devices
2
Description
Control group: In this study, the opposite side of the individuals is control group. After low level laser radiation and receiving dental radiography, the opposite side of the same person receives only red colored laser light (placebo effect) and then dental radiography is taken and the gag reflex intensity will be measured.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Zanjan University of Medical Sciences
Full name of responsible person
Mohsen Alavi
Street address
Haj Ahmad Mahdavi Ave., Shahrak Karmandan., Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3314 8100
Email
dentist@zums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Mina Mohebbian
Street address
Shahrak Karmandan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3314 8100
Email
dentist@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Mahya Farsadeghi
Position
Dentist
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Shahrak Karmandan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
00 98 24 3348100
Email
mahyafarsadeghi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Robab Noormohammadi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahrak karmandan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3314 8100
Email
robab.noormohammadi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mahya Farsadeghi
Position
dentist
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Shahrak Karmandan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3314 8100
Email
mahyafarsadeghi@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
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
after intervention reports
When the data will become available and for how long
1400
To whom data/document is available
Researchers
Under which criteria data/document could be used
email
From where data/document is obtainable
Co responding author
What processes are involved for a request to access data/document