Comparison of severity of pain after three protaper, neolix, reciproc systems in endodontic treatment of patients admitted to Babol dental clinic in year 97
Design
This randomized clinical trial was performed and the sample size was calculated using the same articles as well as by a 90-member formula. Randomly, they were divided into three groups of three, and in each group
Settings and conduct
Patients referring to the special clinic of Babol dental school in randum were divided into 3 groups in the first group (n: 30) root canal therapy using rotated protaper files and in the second group (n: 30) using neolix files and in The third group (n: 30) will treat roots using reciproc files.First, for all patients with desirable anesthesia with lidocaine 2%, with epinephrine 1/80000, after the completion of the isolation access cavity with the ribbed, the length of the canals is determined using the root zx apex locator and radiography confirmed. Each group will be treated differently, and normal saline and sodium hypochlorite washers will be used. Finally, the canals are dried with paper syringe and obturation will be done by lateral condensation using Gutta Perca and AH26 sealer, and the tooth will be temporarily restored with dressing and the VAS questionnaire will be delivered to the patients. After five days, the questionnaire will be delivered to me
Participants/Inclusion and exclusion criteria
inclusion criteria:Patients aged between 20-65 years with irreversible pulpitis for upper and lower jaw molars;exclusion criteria: Patients with systemic conditions, with necrosis teeth or reversible pulpitis
Intervention groups
All 90 patients referred to three groups with three neolix, protaper,
wave one reciprocal are treated
Main outcome variables
Using this study, a suitable system for root canal therapy with less pain is identified
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190514043592N1
Registration date:2019-07-09, 1398/04/18
Registration timing:retrospective
Last update:2019-07-09, 1398/04/18
Update count:0
Registration date
2019-07-09, 1398/04/18
Registrant information
Name
Sanaz Solati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3452 6770
Email address
s.solati@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
2019-01-21, 1397/11/01
Actual recruitment end date
2019-03-16, 1397/12/25
Trial completion date
2019-03-17, 1397/12/26
Scientific title
Comparison of pain intensity after root canal therapy with three different instrumentation technique
Public title
Comparison of pain after root canal therapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 20 to 65 years
Patients with maxillary or mandibular molar that have irreversible pulpitis
Patients with low to moderate visual analog scale
Exclusion criteria:
Patients who have had previous root canal therapy
Patients who receive corticosteroids
Patients who have been using analgesics for 12 hours before root canal therapy
Patients who have a tooth root, calcification, or internal or external resorption or open apex or anatomical complexity (Curve greater than 25 degrees)
Patients whose teeth have any of the swelling and abscess , sensitivity to percusion and periodontal disease
Patients who are pregnant
Dissatisfaction patients to participate in the study
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
N/A
Randomization description
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
The Ethics Committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Street Ganj Afrooz, Babol city
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2019-01-19, 1397/10/29
Ethics committee reference number
IR.MUBABOL.HRI.REC.1397.240
Health conditions studied
1
Description of health condition studied
Irreversible pulpitis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain
Timepoint
4,24,48,72,96 hours after root canal therapy
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, root canal therapy of maxillary and mandibular molars was performed using a Neolix rotary system ( 1.5 N / cm torque and 300-500 rpm speed).
Category
Treatment - Devices
2
Description
Intervention group:In this group, root canal therapy of maxillary and mandibular molars was performed using Reciprocal wave one system ( 4 N / cm torque and 350 rpm speed).
Category
Treatment - Devices
3
Description
Control group: In this group, root canal therapy of maxillary and mandibular molars was performed using protaper rotary system ( 2.5 N / cm torque and 350-450 rpm speed).
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Special Clinic of Babol School of Dentistry
Full name of responsible person
Sanaz Solati
Street address
Babol University of Medical Sciences, Street Ganj Afrooz, Babol city
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9592
Fax
+98 11 3219 0181
Email
info@mubabol.ac.ir
Web page address
https://www.mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr Reza Ghadimi
Street address
Babol University of Medical Sciences, Street Ganj Afrooz, Babol city
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9592
Fax
+98 11 3219 0181
Email
info@mubabol.ac.ir
Web page address
http://www.mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
30
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
Babol University of Medical Sciences
Full name of responsible person
Sanaz Solati
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Aparteman toohid,ro be roye felestin 1 , khiaban felestin , khiaban Amir mazandarani, sari
City
Sari
Province
Mazandaran
Postal code
4851648659
Phone
+98 11 3452 6770
Fax
Email
s.solati@mubabol.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Sanaz Solati
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Aparteman toohid,ro be roye felestin 1 , khiaban felestin , khiaban Amir mazandarani, sari
City
Sari
Province
Mazandaran
Postal code
4851648659
Phone
+98 11 3452 6770
Fax
Email
s.solati@mubabol.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Sanaz Solati
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Aparteman toohid,ro be roye felestin 1 , khiaban felestin , khiaban Amir mazandarani, sari
City
Sari
Province
Mazandaran
Postal code
4851648659
Phone
+98 11 3452 6770
Fax
Email
s.solati@mubabol.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
Because of the privacy of patients
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Using the placement of a study in bookshops as well as submitting articles and publications in the Medical Journal
When the data will become available and for how long
Immediately after printing the results
To whom data/document is available
All medical colleagues
Under which criteria data/document could be used
No condition is considered
From where data/document is obtainable
Academic Library and Magazines
What processes are involved for a request to access data/document
Attend a library or ask for visits from reputable medical journals