Protocol summary

Study aim
comparison of pain scale after single-visit root canal treatment by different temperatures and concentrations of NaOCl in mandibular molars with irreversible pulpitis
Design
A clinical trial with the control group, with parallel groups, double-blind, randomized, phase 2 on 72 patients. RandList software will be used for randomization.
Settings and conduct
In this study, 72 patients at the endodontics department of Tabriz Dental School who have mandibular molars with irreversible pulpitis, will be selected and will be divided into 6 groups of 12. These groups will vary in terms of detergent concentration and room temperature. After treatment of the mandibular molar root of each group, the effect of detergent concentration and temperature on pain reduction will be investigated.
Participants/Inclusion and exclusion criteria
Inclusion: Systemically healthy patient, Patient age 18-65 years Lack of sensitivity to epinephrine and sodium hypochlorite, No facial paraesthesia, Do not take any painkillers 12 hours before treatment Do not take any medication that interferes with anesthesia, No history of trauma, Absence of pathological envelope during probing Completion of an ethical questionnaire and willingness to participate in the study, Lower molar teeth with irreversible pulpitis Exclusion: No lip anesthesia after 15 minutes of block injection, Pain for no reason before treatment, Pregnancy and lactation, Severe periodontal disease Teeth that can not be isolated with my brush, Calcification of the urethra, Teeth with severe irreparable caries, Use of a specific drug or medication
Intervention groups
Patients requiring treatment of mandibular molars with irreversible pulpitis that has been treated and the effect of sodium hypochlorite at different temperatures and concentrations on the severity of patients' pain will be investigated.
Main outcome variables
Intensity of pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220108053665N1
Registration date: 2022-01-24, 1400/11/04
Registration timing: registered_while_recruiting

Last update: 2022-01-24, 1400/11/04
Update count: 0
Registration date
2022-01-24, 1400/11/04
Registrant information
Name
Hadi mokhtari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 5965
Email address
mokhtarih@tbzmeed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-17, 1400/10/27
Expected recruitment end date
2022-02-14, 1400/11/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of pain scale after single-visit root canal treatment by different temperatures and concentrations of NaOCl in mandibular molars with irreversible pulpitis: Double-blind randomized clinical trial
Public title
The effect of using sodium hypochlorite detergent at different temperatures and concentrations on pain intensity after endodontic treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Systemically healthy patient Patient age 18-65 years No hypersensitivity to epinephrine and sodium hypochlorite No facial paraesthesia Do not take any palliatives 12 hours before treatment Do not take any drugs that Anesthesia interferes No history of trauma No pathological envelope during probing Completion of ethical questionnaire and willingness to participate in the study Lower molar teeth with irreversible pulpitis
Exclusion criteria:
No lip anesthesia after 15 minutes of block injection8 Pain for no reason before treatment Pregnancy and lactation Severe periodontal disease Teeth that can not be isolated with a rubberdam Root canal calcification Tooth with severe unrestorable caries Use of a specific drug or narcotic
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
All stages of treatment will be performed in Tabriz Dental School. These 72 people are randomly assigned to the 6 groups mentioned using RandList software. All random numbers are written on a piece of paper. The sheets are folded and placed in a container. For each number, one of the groups is selected. The syringes containing the washing solution are covered with a layer of opaque coating. Each patient chooses a sheet and uses one of the detergents for that patient based on the selected number. Thus, neither the patient nor the researcher is aware of the type of treatment chosen and the study will be double blind.
Blinding (investigator's opinion)
Double blinded
Blinding description
The syringes containing the washing solution are covered with a layer of opaque coating. Each patient chooses a sheet and uses one of the detergents for that patient based on the selected number. Thus, neither the patient nor the researcher is aware of the type of treatment chosen and the study will be double blind. To blind the study, all steps of sodium hypochlorite solution preparation will be performed by a trained assistant who has no role in the clinical process, and to prevent the researcher from feeling the temperature of the washing solutions, an insulating coating will be used on the washing syringes.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Central office of Tabriz University of Medical Sciences, Golgasht Ave, Azadi Blvd
City
Tabriz
Province
East Azarbaijan
Postal code
5165687386
Approval date
2021-12-27, 1400/10/06
Ethics committee reference number
IR.TBZMED.REC.1400.978

Health conditions studied

1

Description of health condition studied
Irreversible pulpitis
ICD-10 code
K04.02
ICD-10 code description
Irreversible pulpitis

Primary outcomes

1

Description
Intensity of pain
Timepoint
Immediately after treatment, 3, 24, 48, 72 hours and 7 days after treatment
Method of measurement
visual analogue scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Patients who have mandibular molars with irreversible pulpitis and are treated with root canal using 1% sodium hypochlorite as a detergent at 40 ° C
Category
N/A

2

Description
Intervention group 2: Patients who have mandibular molars with irreversible pulpitis and are treated with root canal using 0.5% sodium hypochlorite as a detergent at 22° C
Category
N/A

3

Description
Intervention group 3: Patients who have mandibular molars with irreversible pulpitis and are treated with root canal using 0.5% sodium hypochlorite as a detergent at 40 ° C
Category
N/A

4

Description
Intervention group 4: Patients who have mandibular molars with irreversible pulpitis and are treated with root canal using 1% sodium hypochlorite as a detergent at 2.5° C
Category
N/A

5

Description
Intervention group 5: Patients who have mandibular molars with irreversible pulpitis and are treated with root canal using 0.5% sodium hypochlorite as a detergent at 2.5° C
Category
N/A

6

Description
Intervention group 6: Patients who have mandibular molars with irreversible pulpitis and are treated with root canal using 1% sodium hypochlorite as a detergent at 22° C
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Endodontics Department of Tabriz Dental School
Full name of responsible person
Hadi Mokhtari Zanuzi
Street address
Dentistry Faculty of Tabriz, Golgasht Ave, Azadi Blvd
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5921
Email
mokhtari.z.h@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parviz Shahabi
Street address
Central office No. 2, Tabriz University of Medical Sciences, Golgasht Ave, Azadi Blvd
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7310
Email
parvizshahabi@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
Hadi Mokhtari Zanuzi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Dentistry
Street address
Dentistry faculty, Tabriz University of Medical Sciences, Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5921
Email
mokhtari.z.h@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hadi Mokhtari Zanuzi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Dentistry
Street address
Dentistry faculty, Tabriz University of Medical Sciences, Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5921
Email
mokhtari.z.h@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hadi Mokhtari Zanuzi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Dentistry
Street address
Dentistry faculty, Tabriz University of Medical Sciences, Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5921
Email
mokhtari.z.h@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
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