The aim of this clinical trial study is evaluation of the effect of different methods of using anesthetics during impression making on the gag reflex in edentulous patients. Nausea is a defense mechanism in front is pharyngeal and throat stimulations and all dentists and a lot of dental students had this experience with patients who have a gag reflex. Many of the dentistry acts such as preparation of oral-radiography, impression, pharyngeal and throat examination and process of operative treatment close to posterior teeth cause stimulation of nausea. In this study 35 patients referred to the Prosthodontics Department of Dentistry Faculty with severe gag reflex symptoms in initial examination will selected and then will made impression. In first step when we preparing the alginate for impressions, lidocaine anesthetic will be added to mixture of alginate and water, and then will made impression of the patient's upper jaw according to the standard procedure. In another method before the impressions, the posterior areas of the patient's palate will be stained by gel-benzocaine anesthesia and after 3 minutes impression will be made. In the other method, the standard method of upper jaw impressions of the patient will be done. In all stages, a person who don’t have knowledge about study, will evaluate the items in the checklist and will note the intensity of the gag in each group. The collected data will be analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015062822947N1
Registration date:2015-08-30, 1394/06/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-30, 1394/06/08
Registrant information
Name
Vahid Fakhrzadeh
Name of organization / entity
Faculty of Dentistry, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3440 9387
Email address
fakhrzadeh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2015-04-04, 1394/01/15
Expected recruitment end date
2015-08-06, 1394/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of different methods of using anesthetics during impression making on the gag reflex in edentulous patients
Public title
Evaluation of the effect of using anesthetics during impression making on the gag reflex
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: willingness to participate in the study; signing the study informed consent; having severe gagging reflex according GSI(Gagging Severity Index). Exclusion criteria: being treated for other diseases and drug use; having the central or peripheral nervous lesions and oral lesions.
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
35
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht
City
Tabriz
Postal code
Approval date
2015-06-28, 1394/04/07
Ethics committee reference number
tbzmed.rec.1394.300
Health conditions studied
1
Description of health condition studied
Gag reflex
ICD-10 code
J39.2
ICD-10 code description
Reflex- hyperactive gag
Primary outcomes
1
Description
Gag reflex
Timepoint
Immediatly after trail
Method of measurement
Gagging Severity Index
Secondary outcomes
empty
Intervention groups
1
Description
lidocaine anesthetic will be added to mixture of alginate and water, and then will made impression of the patient's upper jaw according to the standard procedure.
Category
Prevention
2
Description
Before the impressions,the posterior areas of the patient's palate will be stained by gel-benzocaien anesthesia4% and after 3 minutes impression will be made.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental Faculty, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Vahid Fakhrzade
Street address
Dental Faculty, Tabriz University of Medical Sciences
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology
Full name of responsible person
Sarvar Alipur
Street address
Tabriz- Golgasht avenue -Vice Chancellor for Research and Technology
City
Tabriz
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 and Technology
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
Tabriz University of Medical Sciences
Full name of responsible person
Dr Vahid Fakhrzadeh
Position
PhD in prosthodontics
Other areas of specialty/work
Street address
Dental Faculty, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 3440 9387
Fax
Email
fakhrzadeh@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Vahid Fakhrzadeh
Position
PhD in prosthodontics
Other areas of specialty/work
Street address
Dental Faculty, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 3440 9387
Fax
Email
fakhrzadeh@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Bahman Hoseinpur
Position
Dentistry student
Other areas of specialty/work
Street address
Dental Faculty, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Phone
+98 41 3440 9387
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)