Assessment of intra-canal cryotherapy after final irrigant activation using XP endo finisher file effects on postoperative pain reduction after canal treatment in molars with irreversible pulpitis
The effect of intracanal cryotherapy and the final activation of the washing agent using the XP endo finisher file
Design
This study is a randomized clinical trial with a control group and a parallel design. This randomized study will be conducted on at least 60 eligible patients. Online random number generation software is used for randomization and participants are assigned to four intervention groups.
Settings and conduct
This study, which will be conducted in a private clinic in Isfahan, is non-blinded. Before starting the study, preparation of the root canals will be done to remove the smear layer
Participants/Inclusion and exclusion criteria
Inclusion criteria: Over 18 years of age; Having a lower or upper molar with irreversible pulpitis; The presence of bleeding in the pulp access cavity
Exclusion criteria:Presence of any systemic disease or allergic reactions; Use of any type of pain reliever or antibiotic within 3 days; History of previous root canal treatment; The presence of sinus tract/local swelling of the gums around the affected tooth; Severe periodontal disease; The presence of periodontal pockets > 3 mm in the affected tooth
Intervention groups
In the first intervention group, 5 ml of 5% EDTA is used for 1 minute and the final rinse is given with 20 ml of normal saline at a temperature of 2.5°C. In the second intervention group, 5 ml of 5% EDTA is used for 1 minute and the final wash is given with 20 ml of normal saline at room temperature. In the third intervention group, 5 ml of 5% EDTA is used for 1 minute and the final wash is given with 20 ml of normal saline at a temperature of 2.5°C. In the fourth intervention group, 5 ml of 5% EDTA is used for 1 minute and the final wash is given with 20 ml of normal saline at room temperature.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N222
Registration date:2024-07-21, 1403/04/31
Registration timing:prospective
Last update:2024-07-21, 1403/04/31
Update count:0
Registration date
2024-07-21, 1403/04/31
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-05, 1403/05/15
Expected recruitment end date
2024-10-06, 1403/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of intra-canal cryotherapy after final irrigant activation using XP endo finisher file effects on postoperative pain reduction after canal treatment in molars with irreversible pulpitis
Public title
Assesment of intra-canal cryotherapy after final irrigant activation by means of XP endo finisher file
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Over 18 years of age
Having a lower or upper molar with irreversible pulpitis
The presence of bleeding in the pulp access cavity
Exclusion criteria:
Presence of any systemic disease or allergic reactions
Use of any type of pain reliever or antibiotic within 3 days
History of previous root canal treatment
The presence of sinus tract/local swelling of the gums around the affected tooth
Severe periodontal disease
The presence of periodontal pockets > 3 mm in the affected tooth
Presence of periapical radiolucency
Bent roots
Root length too long or short
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Using online software to generate random numbers. Divided quadrants are drawn on 60 sheets of paper (as many patients) and random numbers are written on each quadrant. Then, each paper is placed in an envelope. Each patient takes an envelope, and based on that method, the elastic separator is placed in each quadrant. Random number generation and allocation concealment are performed by an impartial observer.
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 Committee of Islamic Azad University of Khorasgan branch
Street address
Vice Chancellor for Research Affairs, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Approval date
2024-05-25, 1403/03/05
Ethics committee reference number
IR.IAU.KHUISF.REC.1403.091
Health conditions studied
1
Description of health condition studied
Teeth with irreversible pulpitis
ICD-10 code
K04.9
ICD-10 code description
Other and unspecified diseases of pulp and periapical tissues
Primary outcomes
1
Description
Pain
Timepoint
6, 12 and 24 hours after treatment
Method of measurement
Using a visual pain scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
In the first intervention group, after the preparation of the root canals, 5 ml of 5% EDTA is used for 1 minute and the final rinse is given with 20 ml of normal saline at a temperature of 2.5°C for 1 minute.
Category
Treatment - Drugs
2
Description
In the second intervention group, 5 ml of 5% EDTA is used for 1 minute and the final wash is given with 20 ml of normal saline at room temperature for 1 minute.
Category
Treatment - Drugs
3
Description
In the third intervention group, 5 ml of 5% EDTA is used for 1 minute and the final wash is given with 20 ml of normal saline at a temperature of 2.5°C for 1 minute.
Category
Treatment - Drugs
4
Description
In the fourth intervention group, 5 ml of 5% EDTA is used for 1 minute and the final wash is given with 20 ml of normal saline at room temperature for 1 minute.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Private clinic
Full name of responsible person
Dr. Parisa Ranjbarian
Street address
Upper Floor of Keshavarzi Bank, Azadegan Building,Sheikh Sadouq Crossroads
City
Isfahan
Province
Isfehan
Postal code
00983135354001
Phone
+98 933 457 1351
Email
bhyasminbh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University of Khorasgan branch
Full name of responsible person
Dr. Majid Meshkini
Street address
Vice Chancellor for Research Affairs, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
meshkini@miums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University of Khorasgan branch
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
Islamic Azad University of Khorasgan branch
Full name of responsible person
Dr. Parisa Ranjbarian
Position
University faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
bhyasminbh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University of Khorasgan branch
Full name of responsible person
Dr. Parisa Ranjbarian
Position
University faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
bhyasminbh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University of Khorasgan branch
Full name of responsible person
Dr. Parisa Ranjbarian
Position
University faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, University Blvd., Arghwanieh, J Sharghi Street
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
bhyasminbh@gmail.com
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