effect of low level laser acustimulation on gag reflex
Design
this parallel group single blind phase 2-3 randomised trialwas performed on 30 - allocated by site to case and control groups - .
Settings and conduct
30 patients were enrolled from Mashhad Dental School . before impression gag reflex severity was measured by GPI ( GAG PREVENTION INDEX) including :
1- tolerance of alginate tray until complete setting
2- tolerance of alginate tray just in initial placement
3- tolerance of empty tray
4- intolerance of tray in oral cavity
to asses subjective gag reflex severity VAS(Visual Analog Scale) was used . in a ruler numbering 0 to 10 . zero representing no gag reflex and 10 representing the worst gag reflex even experienced. number of vomiting cycles also was registered . in intervention group low level laser (Ga-Al-As) 810nm was irradiated foe 1 minute to cv 24 and P6 acupuncture points . after irradiation impression was achieved in 3 mins and severity of gag reflex was registered .in control group all steps were similar except that laser was switched off.this was performed to assess placebo effect.
Participants/Inclusion and exclusion criteria
patients admitted to Mashhad Dental school needing alginate impression for prostodontic or orthodontic treatment ,20 to 60 years old suffering from severe gag reflex
Intervention groups
in intervention group GaAlAs 810 nm,200Mw low level laser was apllied on P6,Cv24 acupuncture points for 1 minute. the skinn was dis infected by alcohol and the laser prob was applied on 1 cm distance from skin . in control group all situation was similar except that laser was switched off.
Main outcome variables
gag reflex severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080906001216N4
Registration date:2020-11-29, 1399/09/09
Registration timing:retrospective
Last update:2020-11-29, 1399/09/09
Update count:0
Registration date
2020-11-29, 1399/09/09
Registrant information
Name
Pegah Mosannen Mozaffari
Name of organization / entity
research center of Mashhad dental faculty,Mashhad University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 513882950115
Email address
mosannenp@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
2017-09-23, 1396/07/01
Actual recruitment end date
2018-05-22, 1397/03/01
Trial completion date
2018-06-22, 1397/04/01
Scientific title
comparison of low level laser acustimulation and no intervention on gag reflex management on patients undergoing maxillary impression
Public title
effect of low level laser acustimulation on gag reflex management
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
patient admitted to Mashhad Dental School
suffering severe Gag reflex
need Alginate impression for denture fabrication or orthodontic treatment
Exclusion criteria:
disagreement to participate in trial
Age
From 20 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
allocation to two groups by ttp://www.randomizer.org (two groups A and B
Blinding (investigator's opinion)
Single blinded
Blinding description
patient was blind about sham laser
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences-Research Ethics Committee
Street address
Vakil Abad BLV
City
Mashhad
Province
Razavi Khorasan
Postal code
911735984
Approval date
2018-09-12, 1397/06/21
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1397.047
Health conditions studied
1
Description of health condition studied
gag reflex
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
gag reflex management
Timepoint
just after intervantion
Method of measurement
GPI = gag prevention index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in this group low level laser acustimulation on accumuncture points for controlling gag reflex (cv24 ,pc6) was performed before obtaining maxillary impression
Category
Prevention
2
Description
Control group: in this group sham laser (placebo)was placed on accumuncture points for controlling gag reflex (cv24 ,pc6) before obtaining maxillary impression.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Dental School
Full name of responsible person
Pegah Mosannen Mozafari
Street address
Vakil Abad Blv
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Fax
+98 51 8882 9500
Email
mosannenp@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Vakil Abad Blv
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
tafaghodiM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Pegah Mosannen Mozafari
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Vakil Abad BLV
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
mosannenp@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Pegah Mosannen Mozafari
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Vakil Ababd BLV, Front of Mellat Park, Mashhad Dental School
City
Mashhad
Province
Razavi Khorasan
Postal code
911735984
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
mosannenp@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
pegah Mosannen Mozafari
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Vakil Ababd BLV
City
Mashhad
Province
Razavi Khorasan
Postal code
911735984
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
mosannenp@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
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
data including demographic data signs and symptoms and intervention results will be released
When the data will become available and for how long
2 months after article publication
To whom data/document is available
academic staff
Under which criteria data/document could be used
the data can be used in further studies with citation to main article
From where data/document is obtainable
pegah mosannen mozafari
What processes are involved for a request to access data/document
email communication , the data will be sent in 4 weeks