To assess the effect of needle gauge on pain during injection of infiltration in buccal maxillary incisor teeth
Design
This is a crossover randomized clinical trial, in which 38 eligible patients will be randomly assigned to the intervention 1 and 2 groups.
Settings and conduct
The eligible children needing to the treatment of buccal maxillary incisor teeth referring to the School of Dentistry in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention 1 and 2 groups through the drawing of lots.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 5 to 7 years,
Need to treat two similar incisor teeth on both sides of the maxilla,
Having positive behavior based on the Frankel scale
Exclusion criteria:
Abscesses, cellulite or oral infections
Intervention groups
Intervention group 1:
Injection of infiltration in buccal maxillary incisor teeth with needle number 30 for the first time and then after 14 days injection of infiltration in buccal maxillary incisor teeth with needle number 27
Intervention group 2:
Injection of infiltration in buccal maxillary incisor teeth with needle number 27 for the first time and then after 14 days injection of infiltration in buccal maxillary incisor teeth with needle number 30
Main outcome variables
Primary outcome:
Pain in the injection site
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N365
Registration date:2020-08-24, 1399/06/03
Registration timing:prospective
Last update:2020-08-24, 1399/06/03
Update count:0
Registration date
2020-08-24, 1399/06/03
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-06, 1399/06/16
Expected recruitment end date
2021-03-15, 1399/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of needle gauge on pain during injection of infiltration in buccal maxillary incisor teeth: A crossover randomized clinical trial
Public title
Effect of needle gauge on pain during injection of infiltration in buccal maxillary incisor teeth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 5 to 7 years,
Need to treat two similar incisor teeth on both sides of the maxilla,
Having positive behavior based on the Frankel scale
Exclusion criteria:
Abscesses, cellulite or oral infections
Age
From 5 years old to 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the right and left sides of the patients to the intervention 1 and 2 groups through the drawing of lots. To do this, we prepare two sheets and write "right" on one sheet and "left" on another. Then, by referring to every patient, one of the sheets will be randomly taken. According to whether the sheet is taken right or left is assigned to the interventions-1 group and the other side to the interventions-2 group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2020-07-26, 1399/05/05
Ethics committee reference number
IR.UMSHA.REC.1399.410
Health conditions studied
1
Description of health condition studied
Tooth Decay
ICD-10 code
K03.81
ICD-10 code description
Cracked tooth
Primary outcomes
1
Description
Pain in the injection site
Timepoint
On the first and 14th days
Method of measurement
Using Wong-Baker FACES scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Injection of infiltration in buccal maxillary incisor teeth with needle number 30 for the first time and then after 14 days injection of infiltration in buccal maxillary incisor teeth with needle number 27
Category
Treatment - Devices
2
Description
Intervention group 2: Injection of infiltration in buccal maxillary incisor teeth with needle number 27 for the first time and then after 14 days injection of infiltration in buccal maxillary incisor teeth with needle number 30
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry in Hamadan city
Full name of responsible person
Atefeh Jamshidi
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
ati123jamshidi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
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
Hamedan University of Medical Sciences
Full name of responsible person
Atefeh Jamshidi
Position
Student of Dentistry
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
ati123jamshidi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Zahra Khosravi
Position
Pediatric Dentist
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
zahrakhosrav@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
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