clinical comparison of two rotary file systems with manual instrumentation in root canal preparation of primary molars
Objectives:
1. Determination of the time of canal preparation for two rotary file systems (FKG iRace plus and M3-immatural) and hand file (K-file)
2. Determination of the time of obturation for two rotary file systems (FKG iRace plus and M3-immatural) and hand file (K-file)
3. Determination of patient cooperation during the canal preparation with rotary file systems (FKG iRace plus and M3-immatural) and hand file (K-file)
4. Determination of intensity and duration of pain immediately after the treatment and during the 6, 12, 24, 48, and 72 hours and 1 week after treatment
5, 6. Determination of clinicaland radiographic success rate for two rotary file systems (FKG iRace plus and M3-immatural) and hand file (K-file) during the 6, 12 and 18 months after treatment.
Design
Randomised, parallel group trial, double-blinded, randomised with randomisation application
Settings and conduct
Pediatric Dentistry Department
Participants/Inclusion and exclusion criteria
children with systemic diseases or with special healthcare needs
Children with poor oral hygiene or periodontal disease
radiographic signs of internal or external root resorption, root canal calcification, non-restorabale teeth
Intervention groups
group 1: root canal preparation with hand files (Control group)
group 2: root canal preparation with rotary file system (M3-immatural, G. T. A., China)
group 3: root canal preparation with rotary file system (FKG, iRace Plus)
Main outcome variables
time of canal preparation and obturation, patient cooperation, pain duration and intensity, clinical and radiographic success
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110823007402N8
Registration date:2022-03-04, 1400/12/13
Registration timing:prospective
Last update:2022-03-04, 1400/12/13
Update count:0
Registration date
2022-03-04, 1400/12/13
Registrant information
Name
Mahtab Memarpour
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1626 3192
Email address
memarpour@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-03, 1401/01/14
Expected recruitment end date
2022-06-21, 1401/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two rotary file systems with manual instrumentation for root canal preparation in primary teeth: a randomized clinical trial
Public title
Rotary file system in primary teeth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
clinical examination reveals carious lesion in primary molar without extension to the root
vital signs during the intervention will be checked and only vital teeth are included in the study
All cases report signs of irreversible pulpitis with chief complaint of spontaneous pain in the past few days. This pain is exacerbated with clod or warm stimuli and the patient requires analgesic consumption.
minimum of two thirds of root remainings
Children of 5-8 years old
Exclusion criteria:
children with systemic diseases or with special healthcare needs
Children with poor oral hygiene or periodontal disease
radiographic signs of internal or external root resorption, root canal calcification, non-restorabale teeth
Age
From 5 years old to 8 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Patient selection is based on the block randomization method with the use of randomization application. For the concealment, Sequentially numbered, sealed, opaque envelopes are used.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient and the two researches who record the time of canal preparation and obturation, pain intensity, and child cooperation during the intervention and also the researcher who interprets the quality of obturation, clinical and radiographic success are blind to the group allocation.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz Dental School
Street address
Shiraz Dental School, Qom Abad street, Qasrodasht avenue
City
Shiraz
Province
Fars
Postal code
7196515878
Approval date
2022-01-05, 1400/10/15
Ethics committee reference number
IR.SUMS.DENTAL.REC.1400.130
Health conditions studied
1
Description of health condition studied
Primary second molar with irreversible pulpitis
ICD-10 code
K04.0
ICD-10 code description
Pulpitis
Primary outcomes
1
Description
measurement of time of canal preparation with chronometer
Timepoint
From initiation to the end of filing
Method of measurement
with chronometer
2
Description
measurement of time of canal obturation with chronometer
Timepoint
From initiation to the end of obturation
Method of measurement
with chronometer
3
Description
patient cooperation
Timepoint
during intervention
Method of measurement
Frankel and FLACC criteria for patient cooperation
4
Description
Intensity and duration of pain
Timepoint
6, 12, 24, 48, 72 hours and 1 week after intervention
Method of measurement
four point pain intensity
5
Description
clinical success
Timepoint
3, 6, 12, and 18 months after treatment
Method of measurement
without signs of pain, abscess, redness, tenderness, mobility, swelling, sinus tract, and pus are considered successful
6
Description
radiographic success
Timepoint
3, 6, 12, and 18 months after treatment
Method of measurement
absence of pathologic findings, radiolucency in furca or periapical
Secondary outcomes
empty
Intervention groups
1
Description
Control group: After access cavity preparation, the root canal will be prepared with hand file. Sodium hypochlorite and normal saline and EDTA (if needed) is used for canal irrigation and lubrication. Each file will be used for 4 teeth maximum. The prepared canals are then dried with paper cones (size 30-35) and filled with Endoflas (Sanlor and Cia. S. en C.S., Cali, Colombia) 1-2 mm shorter than the working length using injection method with Navitip (Ultradent, USA)
Category
Treatment - Devices
2
Description
Intervention group: After access cavity preparation, the root canal will be prepared with rotary file m3-immatural. Sodium hypochlorite and normal saline and EDTA (if needed) is used for canal irrigation and lubrication. Each file will be used for 4 teeth maximum. The prepared canals are then dried with paper cones (size 30-35) and filled with Endoflas (Sanlor and Cia. S. en C.S., Cali, Colombia) 1-2 mm shorter than the working length using injection method with Navitip (Ultradent, USA)
Category
Treatment - Devices
3
Description
Intervention group: After access cavity preparation, the root canal will be prepared with Rotary file iRace plus. Sodium hypochlorite and normal saline and EDTA (if needed) is used for canal irrigation and lubrication. Each file will be used for 4 teeth maximum. The prepared canals are then dried with paper cones (size 30-35) and filled with Endoflas (Sanlor and Cia. S. en C.S., Cali, Colombia) 1-2 mm shorter than the working length using injection method with Navitip (Ultradent, USA)
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Pediatric Dentistry, Shiraz Dental School
Full name of responsible person
Dr. Mahtab Memarpour
Street address
Qomabad street, Qasrodasht avenue
City
Shiraz
Province
Fars
Postal code
7196515878
Phone
+98 912 337 4680
Email
memarpour@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mahtab Memarpour
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
memarpour@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mahtab Memarpour
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
7196515878
Phone
+98 71 3628 0118
Email
memarpour@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahtab Memarpour
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Qomabad street, qasrodasht avenue
City
Shiraz
Province
Fars
Postal code
7196515878
Phone
+98 71 3628 0118
Email
memarpour@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahtab Memarpour
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
qomabad street, qasrodasht avenue
City
shiraz
Province
Fars
Postal code
7196515878
Phone
+98 71 3628 0118
Email
memarpour@sums.ac.ir
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