Comparison of the Effectiveness of Topical Anesthesia Gel and Relaxation Training Exercise on Pain Perception during Infiltration Injection in the Anterior Maxilla
Determination Pain Perception On During Infiltration Injection In the Anterior Maxilla In Relaxation Training Exercise
Determination Pain Perception On During Infiltration Injection In the Anterior Maxilla In Topical Anesthetic Gel
Comparison Pain Perception On During Infiltration Injection In the Anterior Maxilla In Relaxation Training Exercise And Topical Anesthetic Gel
Design
Clinical Trial Without Control Group
Settings and conduct
Children In Kermanshah Dental School Was Applied Topical Anesthetic Gel Before Infiltration Injection In the Anterior Maxilla In 1Visit And After 3 Days Was Applied Bubble Breath Before Infiltration Injection in the Anterior Maxilla In The Other Side
Participants/Inclusion and exclusion criteria
Good Systemic Health And Requiring Dental Treatment Under Maxillary Anterior Infiltration Anesthesia and written Informed Consent from the Parents and Written Informed Assent from the Children ؛ acute pain And Requiring Emergency Dental Treatment And Illness Requiring Special Medical Care
Intervention groups
Comparison Effect Of Banzocaine Gel And Relaxation Training Exercise In Children Before Injection In the Anterior Maxilla
Main outcome variables
Severity Of Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191121045465N1
Registration date:2019-12-14, 1398/09/23
Registration timing:prospective
Last update:2019-12-14, 1398/09/23
Update count:0
Registration date
2019-12-14, 1398/09/23
Registrant information
Name
ُُShahrzad Nematollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 4332 2071
Email address
sh.nematollahi.30@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-31, 1398/10/10
Expected recruitment end date
2020-02-28, 1398/12/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Topical Anesthesia Gel and Relaxation Training Exercise on Pain Perception during Infiltration Injection in the Anterior Maxilla
Public title
Comparison of the Effectiveness of Topical Anesthesia Gel and Relaxation Training on Pain Injection
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Good Systemic Health
Requiring Dental Treatment Under Maxillary Buccal Infiltration Anesthesia
Following Written Informed Consent from the Parents and Written Informed Assent from the Children
Exclusion criteria:
presenting with acute pain
suffering from any illness requiring special medical care
requiring emergency dental treatment
Age
From 10 years old to 12 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Taleghani Dormitory
City
Kermanshah
Province
Kermanshah
Postal code
68618-41619
Approval date
2019-11-05, 1398/08/14
Ethics committee reference number
IR.KUMS.REC.1398.760
Health conditions studied
1
Description of health condition studied
The study on the effect of topical anesthesia gel and relaxation training exercise on pain perception during infiltration injection in the anterior maxilla
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Severity of Pain
Timepoint
Application of Topical Anesthesia Gel And After 3 Days Application Relaxation Training Exercise
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:in Visit 1 Application Topical Anesthesia Gel With Sterile Cotton Applicator 2Minutes at the Height of the Mucobuccal fold over the Target Tooth Before infiltration injection in the anterior maxilla . in Visit 2 Use of the Bubble Breath Exercise as a Relaxation Strategy Before infiltration injection
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermanshah Dental School
Full name of responsible person
Shahrzad Nematollahi
Street address
Taleghani Dormitory
City
Kermanshah
Province
Kermanshah
Postal code
68618_41619
Phone
+98 66 4332 2071
Email
sh.nematollahi.30@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Frid Najafi
Street address
Kermanshah University of Medical Sciences, Building 2, Shahid Beheshti Boulevard, Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
68618_41619
Phone
+98 83 3836 0016
Email
farid_n32@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Shahrzad Nematollahi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Taleghani Dormitory
City
Kermanshah
Province
Kermanshah
Postal code
68618_41619
Phone
+98 66 4332 2071
Email
sh.nematollahi.30@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Shahrzad Nematollahi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Taleghani Dormitory
City
Kermanshah
Province
Kermanshah
Postal code
68618_41619
Phone
+98 66 4332 2071
Email
sh.nematollahi.30@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Shahrzad Nematollahi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Taleghani Dormitory
City
Kermanshah
Province
Kermanshah
Postal code
68618_41619
Phone
+98 66 4332 2071
Email
sh.nematollahi.30@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