This study aims to compare the pain after root canal preparation using Mtwo(NiTi) rotary files and hand K-Files in single-visit endodontic treatment. The Inclusion criteria includes: single canaled teeth needing root canal therapy because of irreversible pulpitis with moderate to severe pain (VAS 4-10). The Exclusion criteria includes: teeth with acute apical periodontitis; teeth with necrotic pulp; patient presenting with abscess or cellulitis. This study is performed on the patients from the Department of Endodontics, Dentistry School, Babol University of Medical Sciences. A sample size of sixty patients is considered. After selected, the patients are randomly assigned into two groups; Group A: root canals are prepared with Mtwo rotary files (Mtwo, VDW, Germany). Group B: root canals are prepared with hand K-files using step-back method. َVAS (Visual Analogue Scale) is explained for the patients and the patients are asked to quantify preoperative pain on VAS scale. After the treatment is done the patient is instructed to quantify the pain intensity on VAS scale in 4, 8, 12 and 24 hour intervals if he or she feels pain, and return after 48 hours for assessment.
The subjects of this study are not aware of which treatment method they receive, thus this is a single-blinded study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014031216973N1
Registration date:2015-06-02, 1394/03/12
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-02, 1394/03/12
Registrant information
Name
Mohammad Kashefinejad
Name of organization / entity
Faculty of Dentistry, Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1229 1408
Email address
m.kashefi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Scienses
Expected recruitment start date
2014-11-21, 1393/08/30
Expected recruitment end date
2015-06-21, 1394/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of post-operative pain after root canal preparation using Mtwo (NiTi) rotary and hand K-File in single visit enododontic treatment
Public title
Comparison of the pain after root canal therapy between the traditional method and a modernized method
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: single canaled teeth needing root canal therapy because of irreversible pulpitis with moderate to severe pain (VAS 4-10)
Exclusion criteria: teeth with acute apical periodontitis; teeth with necrotic pulp; patient presenting with abscess or cellulitis
Age
From 14 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Babol University of Medical Sciences
Street address
University Sq., Ganj Afrooz Ave.
City
Babol
Postal code
Approval date
2015-02-07, 1393/11/18
Ethics committee reference number
305121/ژ/پ
Health conditions studied
1
Description of health condition studied
Irrevesible pulpitis
ICD-10 code
K04.0
ICD-10 code description
Pulpitis
Primary outcomes
1
Description
Pain
Timepoint
4 hours, 8 hours, 12 hours, 24 hours after invention
Method of measurement
VAS scale
Secondary outcomes
empty
Intervention groups
1
Description
Root canals prepared with Mtwo (NiTi) rotary files(VDW, Germany)
Category
Treatment - Other
2
Description
Root canals prepared with hand K-Files(Mani, Japan)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dentistry School
Full name of responsible person
Mohammad Saeed Eram
Street address
Felestin Ave., Velayat Sq.
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Headship of Dental Material Study Center
Street address
Felestin Ave., Velayat Sq.
City
Babol
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
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
Babol University of Medical Sciences
Full name of responsible person
Dr. Mohammad Kashefinejad
Position
Endodontics dept. professor
Other areas of specialty/work
Street address
University Sq., Ganj Afrooz Ave.
City
Babol
Postal code
Phone
+98 11322914089
Fax
Email
m.kashefi@mubabol.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mohammad Saeed Eram
Position
Dental student
Other areas of specialty/work
Street address
Felestin Ave., Velayat Sq.
City
Babol
Postal code
Phone
+98 11322914089
Fax
Email
saeederam69@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mohammad Saeed Eram
Position
Dental student
Other areas of specialty/work
Street address
Felestin Ave., Velayat Sq.
City
Babol
Postal code
Phone
00
Fax
Email
saeederam69@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)