Determination of the effect of using ocular coating on dental surgery on patients' anxiety in impacted molar surgery
Design
the third molar third molar will be surgically implanted using a patient's eye cover and anterior tooth in a different session without using the cover. The first 25 patients will attend the first eye surgeon session and the next session without covering the surgical procedure. The second one will be covered in the first session without covering the eyes and will be covered with a surgical covering at the next session.
Settings and conduct
A study is conducted on persons referred to a private clinic in Isfahan for third molar surgery. The instrument of this study is a standard DAS questionnaire and a visual analog scale (VAS) questionnaire. In this study, the analyst was unaware of which patient was belonging to. It will therefore be blindfolded.
Participants/Inclusion and exclusion criteria
This study is conducted on individuals who are referred to a private clinic for treating third molars . Inclusion criteria for the same degree of impaction for the third molar upper or lower third molar surgery, Class I Patient health status (ASA), lack of mental and mental illness, non-use of any sedative and psychotherapy And having anxiety is modest and reasonable(DAS between 9-14).After the test, the patient will be informed with informed consent based on the Helsinki Statement, and those who are not willing to participate in the study are excluded.
Intervention groups
Individuals referring to a private clinic in Isfahan for treating third molars maxilla or mandible or both
Main outcome variables
The findings of this research project will help in selecting the appropriate preparation protocol for patients requiring third molar surgery. These results can be helpful in choosing the right strategy to reduce dental anxiety in this group.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180312039060N1
Registration date:2018-04-12, 1397/01/23
Registration timing:registered_while_recruiting
Last update:2018-04-12, 1397/01/23
Update count:0
Registration date
2018-04-12, 1397/01/23
Registrant information
Name
Alireza Ebrahimpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4326 0653
Email address
alireza.ebrahimpour.1996@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-03, 1397/01/14
Expected recruitment end date
2018-05-04, 1397/02/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of eye-coverage on anxiety in patients requiring surgical removal of third molars referred to a private office
Public title
Effect of eye-coverage on anxiety in patients requiring surgical removal of wisdom teeth
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The same degree of impaction for surgery of third molar upper or lower teeth
Class I is the patient's health status in the ASA classification
Lack of mental illness
Not taking any kind of sedative and psychotherapy
داشتن اضطرابی در حد متوسط و معقول
Moderate Anxiety Patients (DAS Between 9 and 14)
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
49
Randomization (investigator's opinion)
Randomized
Randomization description
by using coin flip method
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jereyb St., Isfahan University of Medical Sciences and Health Services
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Approval date
2017-12-26, 1396/10/05
Ethics committee reference number
395701
Health conditions studied
1
Description of health condition studied
impacted wisdom tooth
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
patients' anxiety
Timepoint
Before and after surgery
Method of measurement
Dental Anxiety Scale(DAS) questionnaire and Visual Analog Scale(VAS)questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The third molar third molar will be operated by a patient's eye cover and a second-side tooth in a different session without using the cover. The first 25 patients will attend the first eye surgeon session at the next session without covering the surgery. Twenty-two will be covered in the first session without covering the eye, and at the next session will be covered with surgery.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
a private clinic
Full name of responsible person
Dr Amirhossein Moaddabai's clinic
Street address
Street of Sattar Khan - Enghelab 5- Building of Oysters
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3792 6589
Email
alireza.ebrahimpour.1996@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Tahereh Changiz
Street address
Hezar Jereyb St., Isfahan University of Medical Sciences and Health Services
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Mazandaran University of Medical Sciences
Full name of responsible person
mehran ebrahimzadeh
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Blv khazar. faculty of dentistry
City
Sari
Province
Mazandaran
Postal code
۳۳۹۷۱-۴۸۱۵۷
Phone
+98 11 3448 4800
Email
alireza.ebrahimpour.1996@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
mehran ebrahimzadeh
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
blv khazar, faculty of dentistry
City
sari
Province
Mazandaran
Postal code
45632-45698
Phone
+98 11 3356 8974
Email
alireza.ebrahimpour.1996@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
alireza ebrahimpour
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
blv khazar, faculty of dentistry
City
sari
Province
Mazandaran
Postal code
12345-56987
Phone
+98 11 3355 6698
Email
alireza.ebrahimpour.1996@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available