Comparison of the effect of using children's protaper rotary file and manual file in reducing the amount of Enterococcus faecalis bacteria and pain in the treatment of necrotic deciduous molar
Comparison of the effect of using children's protaper rotary file and manual file in reducing the amount of Enterococcus faecalis bacteria and pain in the treatment of necrotic deciduous molar
Design
This is a randomized, non-blinded clinical trial with a parallel design. This randomized study will be conducted on 36 children with necrotic Mollerdum deciduous teeth in the lower jaw. A simple randomization method is used for randomization and the participants are assigned to two intervention groups.
Settings and conduct
This study, which will be conducted in a dental office in Isfahan city, is not blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consent; Milk molar tooth with necrotic pulp; Necrotic second molar teeth
Exclusion criteria:External and internal analysis of teeth; A clear lesion of the furca of the second molar
Intervention groups
In the first intervention group, the canals are prepared using children's Protiper rotary files. Children's rotary files are filed with numbers 20, 25, and 30. After complete filing, a sample is taken from the distal canal again using a paper cane number 40 and transferred to the normal saline environment. Ten dilutions are prepared from each sample and 100 microliters of each dilution is cultured in the blood agar medium. In the second intervention group, we used manual files to clean the channels. In this way, first using the manual file number 15 and after determining the length of the channels from the graph, the cleaning of the channels starts with the filing movement. Then it ends with files number 20, 25, and 30, respectively, of cleaning the channels.
Main outcome variables
The Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N208
Registration date:2023-08-26, 1402/06/04
Registration timing:prospective
Last update:2023-08-26, 1402/06/04
Update count:0
Registration date
2023-08-26, 1402/06/04
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-11, 1402/06/20
Expected recruitment end date
2023-11-11, 1402/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of using children's protaper rotary file and manual file in reducing the amount of Enterococcus faecalis bacteria and pain in the treatment of necrotic deciduous molar
Public title
Comparison of the effect of using two methods of preparation in reducing the amount of bacteria and pain in the treatment of milk teeth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent
Milk molar tooth with necrotic pulp
Necrotic second molar teeth
Age between 5 - 10 years
Exclusion criteria:
External and internal analysis of teeth
..
A clear lesion of the furca of the second molar
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:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done in a simple random method, after identifying eligible patients, they will be randomly assigned a three-digit dedicated code. The last digit on the right determines the patient group. If this number is 0, 1, 2, 3, 4, it will be assigned in the first intervention group, and if this number is 5, 6, 7, 8, 9, it will be assigned in the second intervention group
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University, Khorasgan branch
Street address
Vice Chancellor for Research Affairs, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Approval date
2023-08-15, 1402/05/24
Ethics committee reference number
IR.IAU.KHUISF.REC.1402.169
Health conditions studied
1
Description of health condition studied
Necrotized primery molars
ICD-10 code
K02.5
ICD-10 code description
Caries with pulp exposure
Primary outcomes
1
Description
The pain
Timepoint
The beginning of the study and the end of the study
Method of measurement
Based on visual pain scale
Secondary outcomes
empty
Intervention groups
1
Description
In the first intervention group, the canals are prepared using children's Protiper rotary files. Children's rotary files are filed with numbers 20, 25 and 30. After complete filing, a sample is taken from the distal canal again using a paper cane number 40 and transferred to the normal saline environment. Ten dilutions are prepared from each sample and 100 microliters of each dilution is cultured in the blood agar medium.
Category
Treatment - Other
2
Description
In the second intervention group, we use manual files to clean the channels. In this way, first using the manual file number 15 and after determining the length of the channels from the graph, the cleaning of the channels starts with the filing movement. Then it ends with files number 20, 25 and 30, respectively, of cleaning the channels.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadouq Clinic
Full name of responsible person
Shadi Shirmardi
Street address
41 Alley, Between Sheikh Mofid Three Roads and Nikbakht Crossroads,
City
Isfahan
Province
Isfehan
Postal code
۷۱۹۳۶۱۳۳۱۱
Phone
+98 31 3660 0700
Email
m.zare@khuisf.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University of Isfahan, Khorasgan branch
Full name of responsible person
Dr. Majid Meshkini
Street address
Vice Chancellor for Research Affairs, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
meshkini@miums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University of Isfahan, Khorasgan branch
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
Islamic Azad University of Isfahan, Khorasgan branch
Full name of responsible person
Shadi Shirmardi
Position
Dental student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
m.zare@khuisf.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University of Isfahan, Khorasgan branch
Full name of responsible person
Dr. Parisa Ranjbarian
Position
University faculty member
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
m.zare@khuisf.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University of Isfahan, Khorasgan branch
Full name of responsible person
Shadi Shirmardi
Position
Dental student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
m.zare@khuisf.ac.ir
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