Efficacy determination and comparison of manual and Race rotary files in root canal preparation of primary molars
Design
A randomized, double blinded, controlled clinical trial with a parallel group design of 20 patients.
Settings and conduct
Based on the population of 5 up to 9 years old children, needy to pulpectomy of infectious necrotic primary molars, in the pediatric dentistry department of Qazvin dental school, by the blindness of children, evaluators, and analyzer.
Participants/Inclusion and exclusion criteria
Children 5 up to 9 years old, needy to pulpectomy of infectious necrotic primary molar
Intervention groups
Based on age, Patients will divide into two strata. Each stratum will be grouped into pulpectomy by manual instrument or Race rotary file. Eventually, according to the preparation period, microbial evaluation and child cooperation, the efficacy of rotary and the manual instrument will be compared.
Main outcome variables
Duration of intervention by each of instrument; Cooperation scale of the child throughout intervention; The microbial load of the canal before and after chemomechanical preparation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180429039468N1
Registration date:2018-07-16, 1397/04/25
Registration timing:prospective
Last update:2018-07-16, 1397/04/25
Update count:0
Registration date
2018-07-16, 1397/04/25
Registrant information
Name
fatemeh pachenari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3332 3283
Email address
f.pachenari@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-06, 1397/07/14
Expected recruitment end date
2018-11-05, 1397/08/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy evaluation of manual and Race rotary files in root canal preparation of primary molars: an in vivo study
Public title
Efficacy of Race rotary files in root canal preparation of primary molars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
healthy child
none of a history of the chronic systemic disease
the cooperation basis on frankle criteria ( 3 and 4 groups)
the restorable tooth with the suitable structure for rubber dam
caries with the history of spontaneous and night pain
at least two-thirds of the root present
normal morphology
moderate root angulation (root curvature radius 10-20m, the angle of the curvature 25-39 degrees)
radiographic signs of pulp complication, consist of thin trabeculae, radiolucency of furcation and PDL widening
acute alveolar abscess and fistulae
Exclusion criteria:
physical or mental disability of the child
antibiotic receipt in two last weeks
former pulp therapy
inadequate root length
obstructed and calcified canal
fractured root
pathological internal or external root resorption
internal or external furcation perforation
severe bone resorption, affecting the permanent tooth crypt
type II canals
presence of two distally canals in mandibular molars
Age
From 5 years old to 9 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will select upon nonrandomization simple sampling (convenience sample), between those referred for primary molars pulpectomy to the pediatric dentistry department of Qazvin dental university. With Win Pepi software they will be randomly allocated into two stratifies, 5< up to 7 years and 7< up to 9 years.
Blinding (investigator's opinion)
Double blinded
Blinding description
After the description of intervention methods to parents/guardians, the kind of instrument will specify for the operator, upon software allocation.
The operator won't be blind, due to the different types of instrument.
Via lack of awareness of the investigation's aims, the child and the collector of time will be considered blind. The evaluator and collector of microbiologic data will be blind, through coded samples. By overlaying the monitor, the evaluator and collector of cooperation data will be blind. The analyzer will be blind, on coded patients.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Shahid Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
3419915315
Approval date
2017-08-18, 1396/05/27
Ethics committee reference number
IR.QUMS.REC.1396.224
Health conditions studied
1
Description of health condition studied
infectious necrotic primary molars
ICD-10 code
K04.1
ICD-10 code description
Necrosis of pulp
Primary outcomes
1
Description
Change of the microbial load of canal following instrumentation by manual or rotary file
Timepoint
Sampling before and after chemomechanical preparation of canal at the same session
Method of measurement
Count of colony forming units after aerobic and anaerobic bacterial culture
2
Description
Instrumentation time throughout the manual or rotary file
Timepoint
At the period of canal preparation by the manual or rotary file
Method of measurement
Chronometer
3
Description
Cooperation scale of the child throughout instrumentation
Timepoint
At the period of canal preparation by the manual or rotary file
Method of measurement
Ohio state university behavioral rating scale(OSUBRS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Canal preparation through Race rotary file 2% tapered
Category
Treatment - Devices
2
Description
Control group: Canal preparation through manual instrument 2% tapered
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric Department of Dental school of Qazvin University of Medical Sciences
Full name of responsible person
Seyedeh Fatemeh Pachenari
Street address
Shahid Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3333 6001
Email
pachenari.dds@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Amir Peymani
Street address
Shahid Bahonar Blvd
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3333 6001
Email
pachenari.dds@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
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
Qazvin University of Medical Sciences
Full name of responsible person
Seyedeh Fatemeh Pachenari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Unit 34,floor 3, west building, Aseman towers,maskan 1 St., felestin cross,
City
Qazvin
Province
Qazvin
Postal code
3413941613
Phone
+98 28 3332 3283
Email
pachenari.dds@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Anita Ebrahimi Khanghah
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Shahid Bahonar Blvd,Qazvin university of medical sciences
City
Qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3333 6001
Email
anita.ebrahimi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Seyedeh Fatemeh Pachenari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Unit 34,floor 3, west building, Aseman towers,maskan 1 St., felestin cross
City
Qazvin
Province
Qazvin
Postal code
3413941613
Phone
+98 33323283
Email
pachenari.dds@gmail.com
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