“Studying effect of acupuncture in controlling (reducing) the gag reflex in patients requiring an upper alginate impression in female students of islamic azad dental university ”
1) Considering pronounced gag reflex during dental impression and according to the side effects of conventional techniques for controlling the gag reflex , this study was carried out in 1392, with the aim of examining the effect of acupuncture on those who experience nausea during upper alginate impression.
2) The study was done by clinical trial method of Cross-Over type and the case study consisted of female students of the faculty of dentistry who experienced gag reflex during upper alginate impression
3) The degree of reflex was determined and recorded by GSI (Gagging severity index) and GPI (Gagging Preventive index) on objective form by operator and also by VAS (Visual analogue scale) standard on Subjective form by patients.
4) The patients with GSI≥3 (patients with GSI 1&2) were excluded and those who have signed the consent form were included in the study and were put into three categories based on the severity of their initial reflex.
5) In the control group without acupuncture and in the experimental group 1, acupuncture was carried out on LI4 point with chi sensation and in the experimental group 2, acupuncture was carried out on (shenmen, stomach, throat) points on ear.
6) By considering the nature of the study and groups, sixty samples were taken from 20 people. GSI/GPI VAS
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014042917484N1
Registration date:2014-06-11, 1393/03/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-06-11, 1393/03/21
Registrant information
Name
Samane Noroozi
Name of organization / entity
Azad university
Country
Iran (Islamic Republic of)
Phone
+98 21 2296 5362
Email address
ahmadnoroozi@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2013-10-02, 1392/07/10
Expected recruitment end date
2013-10-12, 1392/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
“Studying effect of acupuncture in controlling (reducing) the gag reflex in patients requiring an upper alginate impression in female students of islamic azad dental university ”
Public title
“Studying effect of acupuncture in controlling (reducing) the gag reflex"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All of whom have had gag reflex of type 3 or more based on both indexes(GSI & VAS)
and they Signed a consent form
Age
From 23 years old to 33 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Islamic Azad university dental branch
Street address
Pasdaran street, Neyestan 10 alley .
City
Tehran
Postal code
Approval date
2013-07-08, 1392/04/17
Ethics committee reference number
د/160/پ
Health conditions studied
1
Description of health condition studied
Acupuncture
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Gag reflex
Timepoint
Before and after intervention
Method of measurement
GSI/GPI &VAS
Secondary outcomes
empty
Intervention groups
1
Description
In sham group acupuncture were carried out on LI4 point with chi sensation
Category
Treatment - Other
2
Description
In case group acupuncture were carried out on (shenmen,stomach,throat) points in ear.
Category
Treatment - Other
3
Description
In control group without acupuncture
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Islamic Azad University, School of Dentistry of Tehran
Full name of responsible person
Investigator
Street address
Pasdaran street Neyestan 10 alley
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Tehran azad University of Medical Sciences,dental branch
Full name of responsible person
Dr Azizi Arash
Street address
Pasdaran street Neyestan 10
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Tehran azad University of Medical Sciences,dental branch
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University, School of Dentistry of Tehran
Full name of responsible person
Investigator
Position
Student
Other areas of specialty/work
Street address
Pasdaran street Neyestan 10 alley
City
Tehran
Postal code
Phone
+98 21 2296 5362
Fax
Email
noroozisamane@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University, School of Dentistry of Tehran
Full name of responsible person
Noroozi Samane
Position
Student
Other areas of specialty/work
Street address
Pasdaran street Neyestan 10 alley
City
Tehran
Postal code
Phone
+98 21 2296 5362
Fax
Email
noroozisamane@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)