Pain control is of significant importance in all dentistry fields. Anesthetic is perhaps the hardest part of treatment in children. The most common method in causing anesthesia in mandibule is the inferior alveolar nerve block. As the block injection has a lasting anesthesia effect in children and also could cause traumatic injury to soft tissues a substitute injection technique is needed. This study compared the two infiltration and block techniques for extraction of mandibular primary first molars.
Materials and methods: in this clinical experimental study forty children aging 5 to 8 years were chosen having the required conditions for the extraction of mandibular primary first bilateral molars. This study was conducted based on cross over desigen. The patients were received a block injection in first right molar and then received an infiltration injection on the other side at the second session respectively. The patient pain was recorded at the instance of injection and extraction on based on SEM scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013052012710N2
Registration date:2013-06-11, 1392/03/21
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-06-11, 1392/03/21
Registrant information
Name
Zeinab Jafary
Name of organization / entity
Dental Iniversity of Khorasgan
Country
Iran (Islamic Republic of)
Phone
+98 31 1778 2855
Email address
z.jafari@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Personal
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2013-07-23, 1392/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of "Infiltration" and "Block" Technique in Control of Extraction Pain of First Primary Mandibular Molars in 5-8 Years Old Children
Public title
Comparison of two local anesthesia techniques for primary dentition extraction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: children aging 5-8 years old; body health and not illness or pain; frankle + or ++ ; need to extraction of mandibular primary first bilateral molars and the inspection of minimum root length.
Exclusion criteria: not referral patient and the erosion of tooth root.
Age
From 5 years old to 8 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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Dental school of Islamic Azad University of khorasgan
Street address
Dental school,Islamic Azad University of khorasgan,arghavanieh boulevard,Khorasgan ,Isfahan
City
isfahan
Postal code
Approval date
2009-05-30, 1388/03/09
Ethics committee reference number
88030905501
Health conditions studied
1
Description of health condition studied
Local anesthesia
ICD-10 code
Y48.3
ICD-10 code description
Local anaesthetics
Primary outcomes
1
Description
Pain
Timepoint
After intervention
Method of measurement
Sound Eye Motor
Secondary outcomes
1
Description
Treatment acceptance
Timepoint
After intervention
Method of measurement
Visual
Intervention groups
1
Description
Use of Block Technique
Category
Treatment - Other
2
Description
Use of infiltration technique
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan professinal clinics
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dental Faculty, Islamic Azad University Khorasgan isfahan
Full name of responsible person
Benyamin Modarres
Street address
Dental school,Islamic Azad University of khorasgan,arghavanieh boulevard,Khorasgan ,Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dental Faculty, Islamic Azad University Khorasgan isfahan
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
Islamic Azad University Khorasgan
Full name of responsible person
Zeinab Jafary
Position
Resident of pediatric dentistry
Other areas of specialty/work
Street address
Dental faculty, Islamic Azad University Khorasgan, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1535 4001
Fax
Email
dr_zjafary82@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University Khorasgan
Full name of responsible person
Zeinab Jafary
Position
Resident of pediatric dentistry
Other areas of specialty/work
Street address
Dental faculty, Islamic Azad University Khorasgan, Isfahan
City
Isfahan
Postal code
Phone
+98 31 1535 4001
Fax
Email
dr_zjafary82@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University of Khorasgan
Full name of responsible person
zeinab jafary
Position
resident of pediatric dentistry
Other areas of specialty/work
Street address
Dental faculty of islamic azad university of khorasgan,isfahan,iran
City
Isfahan
Postal code
Phone
+98 31 1535 4001
Fax
Email
dr_zjafary82@yahoo,com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)