Protocol summary
-
Study aim
-
The aim of this study is to evaluate post instrument pain after cleaning and shaping using Gentelfile(Tornado) system and comparing with Mtwo system.
-
Design
-
The patients are devided in 2 groups randomly by using a random number table. Each patient is assigned a 4-digit code, if the end digit on the right is 2.7,9, the patient is in Mtwo group, and if the final digit is 3,5,6, the patient is in Gentlefile group. The total sample size is 30 and the phase does not apply in this study.
-
Settings and conduct
-
The study population is people who visit Dr Reza Hatam office (endodontist) for molar root canal treatment. In this study, patients are evaluated for inclusion and exclusion criteria. Blindness is performed for the pain assessor and the patient. They have no information about the cleaning and shaping system.The assessor calls patients at specified intervals after treatment and asks them about post-treatment pain and taken analgesics(Ibuprofen 400mg).
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria is age 18 to 60 years old. Exclusion criteria is internal and external resorption,periodontal disease,retreatment cases,necrotic tooth,tooth with calcified canals,immature roots,systemic problems which have contraindication for root canal treatment.
-
Intervention groups
-
patients are randomly divided into 2 groups. Each group is treated with one of the Gentlefile(Tornado), Mtwo system. Each patient is assigned a code. Codes are kept in envelopes. The patient randomly selects one of the envelopes before entering. The specialist chooses the cleaning and shaping system based on the codes. The treatment steps in all 2 groups are exactly the same.The only difference is in the cleanning and shaping system used.
-
Main outcome variables
-
The amount of post endodontic treatment pain
General information
-
Reason for update
-
In this study, it was decided to compare three study groups and three interventions. These interventions included clearing and shaping the root canal with Mtwo rotary system, cleaning and shaping the root canal with Rotaper Gold rotary system, and cleaning and shaping the root canal with Gentlefile (Tornado) rotary system.Unfortunately, due to the corona epidemy and the decrease in the number of patients referred to the dental office and
On the other hand, due to the lack of equipment for cleaning and shaping the root canal with Protaper Gold system, the group of researchers decided to remove the Protaper Gold group at the discretion of the Research Council of the School of Dentistry. Patient treatment is ongoing for the remaining two interventions. However, the intervention of cleaning and shaping the root canal with the Protaper Gold rotary system has been eliminated.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20200707048043N1
Registration date:
2020-09-08, 1399/06/18
Registration timing:
prospective
Last update:
2020-12-19, 1399/09/29
Update count:
1
-
Registration date
-
2020-09-08, 1399/06/18
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2020-09-30, 1399/07/09
-
Expected recruitment end date
-
2021-01-30, 1399/11/11
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Evaluation of post instrument pain after cleaning and shaping using Gentelfile(Tornado) system and comparing with Mtwo rotary system(double blinded clinical trial).
-
Public title
-
Evaluation of post instrument pain using Gentelfile(Tornado) system and comparing with Mtwo system.
-
Purpose
-
Supportive
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
age between 18 to 60 years old
Exclusion criteria:
external root resorption
internal root resorption
periodontal disease
retreatment cases
necrotic tooth
tooth with calcified canals
immature roots
systemic problems which have contraindication for root canal treatment such as uncontrolled diabets ,osteoradio necrosis ,uncontrolled blood presure
-
Age
-
From 18 years old to 60 years old
-
Gender
-
Both
-
Phase
-
N/A
-
Groups that have been masked
-
- Participant
- Outcome assessor
-
Sample size
-
Target sample size:
30
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
A random number table is used for randomization. Each patient is assigned a 4-digit code, if the end digit on the right is 2.7,9, the patient is in the Mtwo group, and if the final digit is 3,5,6, the patient is in the Gentlefile group. All codes are recorded on paper and stored in specific envelopes. The envelopes are arranged randomly and the patient selects them. The total sample size is 45 and the phase does not apply in this study.
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
In this study both the patient and the outcome assessor will be blinded.The patients won`t have any information about cleaning and shaping system. Pain assessor will have no information about division of patients in groups.
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2020-08-21, 1399/05/31
-
Ethics committee reference number
-
IR.KUMS.REC.1399.474
Health conditions studied
1
-
Description of health condition studied
-
post endodontic treatment pain
-
ICD-10 code
-
-
ICD-10 code description
-
Primary outcomes
1
-
Description
-
patient`s pain levels in Visual Analogue Scale
-
Timepoint
-
The pain is evaluated 2,4,8,12,24,48,72 hours and one week after treatment.
-
Method of measurement
-
Visual Analogue Scale
Secondary outcomes
1
-
Description
-
Number of Ibuprofen 400 mg taken by the patient
-
Timepoint
-
Every 6 hours after endodontic treatment
-
Method of measurement
-
Visual Analogue Scale
Intervention groups
1
-
Description
-
The first comparison group is the group in which the cleaning and shaping process is done with the Gentlefile (Tornado) system.
-
Category
-
Treatment - Devices
2
-
Description
-
The second comparison group is the group in which the cleaning and shaping process is done with the Mtwo system.
-
Category
-
Treatment - Devices
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Kermanshah 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
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Yes - There is a plan to make this available
-
Study Protocol
-
Yes - There is a plan to make this available
-
Statistical Analysis Plan
-
Yes - There is 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
-
Undecided - It is not yet known if there will be a plan to make this available
-
Title and more details about the data/document
-
After completing the study and deidentifying the information of the participants, the main outcome of the study will be shared through Kermanshah University of Medical Sciences.
-
When the data will become available and for how long
-
Documents will be available 6 months after publication.
-
To whom data/document is available
-
Ducuments will be available to researchers working at academic institutions.
-
Under which criteria data/document could be used
-
Researchers can use the documents of the current study to conduct systematic review and meta-analysis studies.
-
From where data/document is obtainable
-
To access the documents, you can go to the following postal address: Postal Code: 671584714, Room 4, First floor, Vice Chancellor for Research and Technology, Building No. 2, Kermanshah University of Medical Sciences, Shahid Beheshti Boulevard,Kermanshah or Or by telex:083-38393158 or Email address: src_research@kums.ac.ir.
-
What processes are involved for a request to access data/document
-
Documents can be accessed by referring to the mentioned addresses and introducing the relevant university institution.
-
Comments
-