Generally local anesthethic injection is one of the dental procedure that makes the most negative respond in the children and reduce the pain of this is one of the big challenge in the children dentidtry. 40 volunteer children that need bilaterall inferior alveolar injection with similar treatment indication in 2 side of mandible will participate in this study. The inferior alveolar block injection will be performed by cold needle and needle with room temperature in 2 side of mandible. In half of children randomly in first session will used needle with room temperature and for the other half vice versa. For preparation of cold needle, needles will put in the freezer in -7°c . the selection of the side of injection ( right or left) and kind of first injection ( with cold needle or needle with room temperature ) will be randomly. Injection will performed by specialist in pediatric dentistry that will be same for all and the constant assistant ( student) who will help the injector in dental procedures and evaluate the intensity of the pain injection by sound, eyes and movement of children. . before the injection will be used the benzocain gel for 30 second. the interval between the session will be 1 week. Criteria for Pain Scale: sound scale, eyes, movements (SEM) are part of the behavioural -assessments of pain scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013050413218N1
Registration date:2013-05-19, 1392/02/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-05-19, 1392/02/29
Registrant information
Name
Elham Hosseini
Name of organization / entity
Zahedan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 937 203 9978
Email address
drelhamhosseini@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research and Technology Assistance of Zahedan University of Medical Science
Expected recruitment start date
2013-04-06, 1392/01/17
Expected recruitment end date
2013-05-28, 1392/03/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of needle temperature on the intensity of pain due to inferior alveolar nerve block injection of children 5-10 years old.
Public title
evaluation of cold needle on anesthetic injection pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children 5-10 years old who needs bilateral inferior alveolar injection with similar treatment indication in 2 side of mandible and those who will be in cooperative group (frankle 3-4). Exclusion criteria: children with systemic disease, mental retardation, history of dental treatment, Sensitivity to anesthetics, Taking medicines that affect pain and any abscess and fistula in the desired area.
Age
From 5 years old to 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
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
Zahedan University of Medical Science
Street address
Zahedan University of Medical Science, Dr. Hesabi square
City
Zahedan
Postal code
9817699693
Approval date
2013-04-13, 1392/01/24
Ethics committee reference number
61-92
Health conditions studied
1
Description of health condition studied
injection pain
ICD-10 code
R52.0
ICD-10 code description
Acute pain
Primary outcomes
1
Description
injection pain
Timepoint
during injection
Method of measurement
sum of the points of voice, eye and movement according to SEM parameters. point 3(minimum pain intensity) to 12(maximum pain intensity).
Secondary outcomes
empty
Intervention groups
1
Description
needle with room temperature
Category
Other
2
Description
cold needle
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric Department, Zahedan Dental School
Full name of responsible person
Mitra Zare
Street address
Dental School, east Azadegan street.
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research and Technology Assistance of Zahedan University of Medical Science
Full name of responsible person
Dr. Hamid Reza Mahmoodzade Sagheb
Street address
Zahedan University of Medical Science, Dr. Hesabi square
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research and Technology Assistance of Zahedan University of Medical Science
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
Zahedan University of Medical Science
Full name of responsible person
Mitra Zare
Position
Dental Student
Other areas of specialty/work
Street address
Bozorgmehr 36
City
Zahedan
Postal code
Phone
+98 54 1241 0411
Fax
Email
zare.m19@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Science
Full name of responsible person
Elham Hosseini
Position
Specialist in Pediatric Dentistry
Other areas of specialty/work
Street address
Dental school, east Azadegan street
City
Zahedan
Postal code
Phone
+98 54 1244 1824
Fax
Email
drelhamhosseini@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Science
Full name of responsible person
Mitra Zare
Position
Dental student
Other areas of specialty/work
Street address
Bozorgmehr 36
City
Zahedan
Postal code
Phone
+98 54 1241 0411
Fax
Email
zare.m19@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)