Comparison of pain after single-visit root canal treatment following different irrigant
Design
Clinical trial with parallel, randomized groups.The randomization method is simple and using RandList1.2 software. 51 people of each groups will be divided into three 17 people groups. Irrigants serum, sodium hypochlorite and chlorhexidine will be used for the each groups of tooth type during root canal treatment . Finally, the amount of pain in the groups will be measured and compared.
Settings and conduct
The study will be performed in the endodontics department of Tabriz Dental School. 153 patients will be selected. In order to evaluate the effects of different detergents, sterile serum, sodium hypochlorite and chlorhexidine gluconate will be used in different groups. Pain intensity will be recorded daily in VAS form for one week. Participants as well as the evaluating researcher are unaware of the type of treatment performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1.No facial paraesthesia
2.No history of trauma
8.Absence of pathological envelope during probing
9.Completing the ethical questionnaire and willingness to participate in the study
Exclusion criteria:
2.Pain for no reason before treatment
3.Pregnancy and lactation
4.Severe periodontal disease
5.Overfilling the root canal space
6.Teeth that can not be separated by a rubber barrier
7.Root canal calcification
8. Roots and teeth that are not suitable for further restoration
9. Use drugs or special medication
Intervention groups
Group 1: Use of sterile serum as a irrigant
Group 2: Use of 2.5% sodium hypochlorite as a irrigant
Group 3: Use of chlorhexidine gluconate 2% as a irrigant
Main outcome variables
The amount of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101108005141N8
Registration date:2020-11-24, 1399/09/04
Registration timing:retrospective
Last update:2020-11-24, 1399/09/04
Update count:0
Registration date
2020-11-24, 1399/09/04
Registrant information
Name
Shahriar Shahi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41133559659
Email address
shahis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-05, 1399/06/15
Expected recruitment end date
2020-10-06, 1399/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of pain after single-visit root canal treatment following different irrigants; randomized clinical trial
Public title
Comparison of pain after root canal treatment following different irrigants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Systemically healthy patient
Patient age 65_18 years
No allergy to chlorhexidine, sodium hypochlorite
No facial paresthesia
not taking any painkillers 6 hours before treatment
not taking any medication that interferes with anesthesia
No history of trauma
Absence of pathological pocket during probing
Completion of the ethical questionnaire and willingness to participate in the study
The patient who needs root canal treatment
Exclusion criteria:
Pain for no reason before treatment
Pregnancy and lactation
Severe periodontal disease
Overfilling the root canal space
Teeth that can not be isolated by a rubber dam
Root canal calcification
Roots and teeth that are not suitable for further restoration
Use of a specific drug or medication
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
153
Randomization (investigator's opinion)
Randomized
Randomization description
153 patients selected in this study will be selected by available sampling method. The study will be performed in three different groups on necrotic - symptomatic and asymptomatic molars . In order to investigate the effects of different irrigants in each of the dental groups (necrotic - asymptomatic - symptomatic) 51 people in each group will be placed randomly using Rand list 1.2 software in three groups with 17 people each . In each of these 17 groups, one of the irrigans chlorhexidine - sodium hypochlorite or serum will be used.
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
Ethics committe of Tabriz University of Medical Sciences
Street address
3rd floor, No2 Centeral Building , Tabriz University of Medical Sciences, ,Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2020-08-31, 1399/06/10
Ethics committee reference number
IR.TBZMED.REC.1399.562
Health conditions studied
1
Description of health condition studied
Dental caries
ICD-10 code
K02.5
ICD-10 code description
Caries with pulp exposure
Primary outcomes
1
Description
The amount of pain
Timepoint
Daily for a week
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Using sterile serum as a irrigant during root canal treatment in symptomatic, asymptomatic, necrotic molars.The volume of irrigant between each instrumentation will be 2 ml
Category
Treatment - Other
2
Description
Intervention group 2: Use 2.5% sodium hypochlorite as a irrigantduring root canal treatment in symptomatic, asymptomatic , necrotic molars.The volume of irrigant between each instrumentation will be 2 ml
Category
Treatment - Other
3
Description
Intervention group 3: Use chlorhexidine gluconate 2% as a irrigant during root canal treatment in symptomatic, asymptomatic , necrotic molars.The volume of irrigant between each instrumentation will be 2 ml
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences
Full name of responsible person
Shahriar Shahi
Street address
3rd floor, No2 Centeral Building , Tabriz University of Medical Sciences, ,Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
sshahriar32@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samiei
Street address
3rd floor, No2 Centeral Building , Tabriz University of Medical Sciences, ,Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
sshahriar32@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Shahriar Shahi
Position
Professor of Endodontics
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
3rd floor, No2 Centeral Building , Tabriz University of Medical Sciences, ,Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
sshahriar32@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Shahriar Shahi
Position
Professor of Endodontics
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
3rd floor, No2 Centeral Building , Tabriz University of Medical Sciences, ,Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
sshahriar32@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Shahriar Shahi
Position
Professor of Endodontics
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
3rd floor, No2 Centeral Building , Tabriz University of Medical Sciences, ,Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
sshahriar32@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