Comparison of Two Methods: Infiltration anesthesia and inferior Alveolar Block anesthesia in Controlling Pulpotomy’s Pain in First Primary Mandibular Molars
Introduction: Pain control is an important issue in dentistry. Anaesthetic injection is perhaps the hardest part of treatment in children. The most common method used in mandible area is the inferior alveolar nerve block. As the block injection has a lasting anaesthetic effect in children and could cause traumatic injury to the soft tissue, a substitute injection technique is needed. This study compared two infiltration and block techniques in pain control for pulpotomy in primary first mandibular molars. Materials and methods: In this clinical trial study forty children age between 5 and 8 years were invited to participate. They had the required conditions for the pulpotomy of the mandibular primary first molars. bilaterally. This study used cross over design. The patients were randomly divided into two groups of A and B. The patients in group A received an Infiltration injection in the first right molar and a Block injection on the other side in the first and the second sessions respectively. The patients in group B received a Block injection in first left molar and an Infiltration injection on the other side in the first and the second sessions respectively. The patient’s pain was recorded at the instance of injection and the entering the pulp on the based on SEM (Sound Eye Motor) scale. The data was analyzed by "Man whitney U" & "wilcoxon signed rank" tests at 95% confidence level (P‹0.05).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201009084714N1
Registration date:2010-12-14, 1389/09/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-12-14, 1389/09/23
Registrant information
Name
Davoud ghasemi
Name of organization / entity
Islamic Azad University Khorasgan Branch
Country
Iran (Islamic Republic of)
Phone
+98 31 1535 4053
Email address
d.ghasemi@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2009-02-19, 1387/12/01
Expected recruitment end date
2009-06-05, 1388/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Two Methods: Infiltration anesthesia and inferior Alveolar Block anesthesia in Controlling Pulpotomy’s Pain in First Primary Mandibular Molars
Public title
Comparison of Two Methods: Infiltration anesthesia and inferior Alveolar Block anesthesia in Controlling Pulpotomy’s Pain in First Primary Mandibular Molars
Purpose
Treatment
Inclusion/Exclusion criteria
1) age between 5 and 8 2) having the required conditions for the pulpotomy of the mandibular primary first molars bilaterally 3) Not having systemic diseases 4) willing to participate in the study
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)
Single blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad University of Khorasgan
Street address
Islamic Azad University of Khorasgan- Dental school - Arghavanieh -Jey St
City
Isfahan
Postal code
Approval date
2007-07-21, 1386/04/30
Ethics committee reference number
638/p
Health conditions studied
1
Description of health condition studied
pulp therapy in primary dentition
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain
Timepoint
pulp chamber removal - anesthetic injection
Method of measurement
SEM scale (Sound eye motor)
Secondary outcomes
empty
Intervention groups
1
Description
Infiltration: Injection of anaesthetic solution next to the root of the teeth; pulpotomy: removal of the coronal portion of the pulp in primary teeth
Category
Treatment - Other
2
Description
Mandibular block injection: Injection of anaesthetic solution next to the inferior alveolar nerve- pulpotomy: removal of the coronal portion of the pulp in primary teeth
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Professional Dental Clinics in Isfahan
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isalamic Azad university of Khorasgan Branch
Full name of responsible person
Isalamic Azad university of Khorasgan Branch- Dental School
Street address
Isalamic Azad university of Khorasgan Branch- Dental School- Jey St - Arghavnieh
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isalamic Azad university of Khorasgan Branch
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 - Dental School
Full name of responsible person
Davood Ghasemi
Position
Assistant Professor of Pediatric Dentistry
Other areas of specialty/work
Street address
Islamic Azad University - Dental School- Jey St - Arghavnieh
City
Isfahan
Postal code
Phone
+98 31 1535 4053
Fax
Email
d.ghasemi@khuisf.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University of Khorasgan
Full name of responsible person
Davood Ghasemi
Position
Assistant Professor of Pediatric Dentistry
Other areas of specialty/work
Street address
Islamic Azad University - Dental school- Jey St - Arghavnieh
City
Isfahan
Postal code
Phone
+98 215354053
Fax
Email
d.ghasemi@khuisf.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University of Khorasgan
Full name of responsible person
Davood Ghasemi
Position
Assistant Professor of Pediatric Dentistry
Other areas of specialty/work
Street address
City
Postal code
Phone
+98 31 1535 4053
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)