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General information
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1- In the previous protocol, teeth with normal peri-apical conditions meant teeth that needed root canal retreatment due to leakage.
2- The treatment protocol of the control group was explained more specifically.
1- In the previous protocol, teeth with normal peri-apical conditions meant teeth that needed root canal retreatment due to leakage. 2- The treatment protocol of the control group was explained more specifically.
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1- در پروتوکل قبلی منظور از دندان های با شرایط پری اپیکال نرمال، دندان هایی بود که به دلیل لیکیج نیاز به درمان ریشه مجدد داشتند.
2- پروتوکل درمان گروه کنترل مشخص تر توضیح داده شد.
1- در پروتوکل قبلی منظور از دندان های با شرایط پری اپیکال نرمال، دندان هایی بود که به دلیل لیکیج نیاز به درمان ریشه مجدد داشتند. 2- پروتوکل درمان گروه کنترل مشخص تر توضیح داده شد.
Patients should be classified as ASA I or ASA II in terms of systemic health
The teeth should have no spontaneous pain
The teeth should have a normal periapical condition or have an asymptomatic lesion
Patients should be classified as ASA I or ASA II in terms of systemic health
The teeth should have no spontaneous pain
Teeth with periapical lesions or teeth with clear evidence of leakage.
Patients should be classified as ASA I or ASA II in terms of systemic health The teeth should have no spontaneous pain TheTeeth with periapical lesions or teeth should have a normal periapical condition or have an asymptomatic lesionwith clear evidence of leakage.
بیماران از لحاظ سیستمیک در طبقه بندی ASA I ویا ASA II قرار بگیرند
دندان ها می بایست بدون درد خود به خود باشند
دندان ها از نظر پری اپیکال نرمال بوده و یا ضایعه بدون علامت داشته باشند
بیماران از لحاظ سیستمیک در طبقه بندی ASA I ویا ASA II قرار بگیرند
دندان ها می بایست بدون درد خود به خود باشند
دندان های دارای ضایعه پری اپیکال و یا دندان هایی که شواهد واضحی از وجود لیکیج دارند.
بیماران از لحاظ سیستمیک در طبقه بندی ASA I ویا ASA II قرار بگیرند دندان ها می بایست بدون درد خود به خود باشند دندان ها از نظرهای دارای ضایعه پری اپیکال نرمال بوده و یا ضایعه بدون علامت داشته باشنددندان هایی که شواهد واضحی از وجود لیکیج دارند.
Intervention groups
#1
Control group: Patients who undergo non-surgical root canal retreatment in one visit under standard treatment protocols
Control group: Patients who undergo non-surgical root canal retreatment under the same standard treatment as the intervention group, so that the only difference between the treatment process of the two groups is the normal saline temperature used for the final cleaning of the canal.
Control group: Patients who undergo non-surgical root canal retreatment in one visit under the same standard treatment protocolsas the intervention group, so that the only difference between the treatment process of the two groups is the normal saline temperature used for the final cleaning of the canal.
گروه کنترل: بیماران نیازمند درمان ریشه غیرجراحی یک جلسه ای تحت درمان استاندارد
گروه کنترل: بیماران نیازمند درمان ریشه غیرجراحی یک جلسه ای تحت درمان استاندارد مشابه گروه مداخله ، به گونه ای که تنها تفاوت بین روند درمانی دو گروه، دمای نرمال سالین مورد استفاده برای شستشوی نهایی کانال می باشد.
گروه کنترل: بیماران نیازمند درمان ریشه غیرجراحی یک جلسه ای تحت درمان استاندارد مشابه گروه مداخله ، به گونه ای که تنها تفاوت بین روند درمانی دو گروه، دمای نرمال سالین مورد استفاده برای شستشوی نهایی کانال می باشد.
Recruitment centers
#1
Name of recruitment center - English: School of Dentistry- Tehran University of Medical Sciences
Name of recruitment center - Persian: دانشکده دندانپزشکی- دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Mohammad Mahdi Kiafar
Full name of responsible person - Persian: محمد مهدی کیافر
Street address - English: Endodontics department، tehran university of medical sciences school of dentistry, north kargar
Street address - Persian: انتهای خیابان کارگر شمالی، بعد از سازمان انرژی اتمی، دانشکده دندان پزشکی دانشگاه تهران، طبقه پهارم درمانی، بخش اندودانتیکس
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1439955991
Phone: +98 21 6636 9439
Fax:
Email: m-kiafar@razi.tums.ac.ir
Web page address:
Name of recruitment center - English: School of Dentistry- Tehran University of Medical Sciences
Name of recruitment center - Persian: دانشکده دندانپزشکی- دانشگاه علوم پزشکی تهران
Full name of responsible person - English: Mohammad Mahdi Kiafar
Full name of responsible person - Persian: محمد مهدی کیافر
Street address - English: Endodontics department, Tehran university of medical sciences school of dentistry, North Kargar
Street address - Persian: انتهای خیابان کارگر شمالی، بعد از سازمان انرژی اتمی، دانشکده دندان پزشکی دانشگاه تهران، طبقه پهارم درمانی، بخش اندودانتیکس
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1439955991
Phone: +98 21 6636 9439
Fax:
Email: m-kiafar@razi.tums.ac.ir
Web page address:
Name of recruitment center - English: School of Dentistry- Tehran University of Medical Sciences Name of recruitment center - Persian: دانشکده دندانپزشکی- دانشگاه علوم پزشکی تهران Full name of responsible person - English: Mohammad Mahdi Kiafar Full name of responsible person - Persian: محمد مهدی کیافر Street address - English: Endodontics department، tehran, Tehran university of medical sciences school of dentistry, north kargarNorth Kargar Street address - Persian: انتهای خیابان کارگر شمالی، بعد از سازمان انرژی اتمی، دانشکده دندان پزشکی دانشگاه تهران، طبقه پهارم درمانی، بخش اندودانتیکس City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1439955991 Phone: +98 21 6636 9439 Fax: Email: m-kiafar@razi.tums.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Sholeh Ghabraei
Full name of responsible person - Persian: شعله غبرایی
Street address - English: Endodontics department، tehran university of medical sciences school of dentistry, north kargar
Street address - Persian: انتهای خیابان کارگر شمالی، بعد از سازمان انرژی اتمی، دانشکده دندان پزشکی دانشگاه تهران، طبقه پهارم درمانی، بخش اندودانتیکس
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1439955991
Phone: +98 912 207 5034
Fax:
Email: sholehghabraei@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Sholeh Ghabraei
Full name of responsible person - Persian: شعله غبرایی
Street address - English: Endodontics department, Tehran university of medical sciences school of dentistry, North Kargar
Street address - Persian: انتهای خیابان کارگر شمالی، بعد از سازمان انرژی اتمی، دانشکده دندان پزشکی دانشگاه تهران، طبقه پهارم درمانی، بخش اندودانتیکس
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1439955991
Phone: +98 912 207 5034
Fax:
Email: sholehghabraei@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Sholeh Ghabraei Full name of responsible person - Persian: شعله غبرایی Street address - English: Endodontics department، tehran, Tehran university of medical sciences school of dentistry, north kargarNorth Kargar Street address - Persian: انتهای خیابان کارگر شمالی، بعد از سازمان انرژی اتمی، دانشکده دندان پزشکی دانشگاه تهران، طبقه پهارم درمانی، بخش اندودانتیکس City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1439955991 Phone: +98 912 207 5034 Fax: Email: sholehghabraei@yahoo.com Web page address:
Protocol summary
Study aim
Evaluating the effect of intracanal cryotherapy with normal saline on post-operative pain in single visit root canal treatment in single-rooted anterior and premolar teeth.
Design
A two-armed randomized clinical trial with a control group, double-blind (patient and researcher responsible for data analysis), on 46 patients.
Settings and conduct
Patients in both the intervention and control groups at the Faculty of Dentistry of Tehran University of Medical Sciences undergo non-surgical root canal retreatment and after the treatment, they are given a form to record the amount of pain after the treatment and the number of painkillers consumed for a week.
Participants/Inclusion and exclusion criteria
Patients in need of non-surgical root canal retreatment in anterior teeth and single-rooted premolars who do not have pain before treatment and are in the ASA I and ASA II groups in terms of systemic health are included in the study.
Patients who have taken analgesics or antibiotics before the treatment or have a history of chronic maxillofacial pain are not included in the study.
In case of swelling, sinus tract, periodontal disease, and irreparable coronal destruction, patients are excluded from the study.
Intervention groups
Intervention group: patients in need of non-surgical root canal retreatment in anterior teeth and single-rooted premolars
Control group: patients in need of non-surgical root canal retreatment in anterior teeth and single-rooted premolars
Main outcome variables
Pain level after treatment on NRS scale up to one week after treatment
The number of painkillers taken up to one week after the treatment
General information
Reason for update
1- In the previous protocol, teeth with normal peri-apical conditions meant teeth that needed root canal retreatment due to leakage.
2- The treatment protocol of the control group was explained more specifically.
Acronym
IRCT registration information
IRCT registration number:IRCT20211231053574N1
Registration date:2022-12-19, 1401/09/28
Registration timing:registered_while_recruiting
Last update:2023-06-01, 1402/03/11
Update count:1
Registration date
2022-12-19, 1401/09/28
Registrant information
Name
Mohammad Mahdi Kiafar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3342 1330
Email address
m-kiafar@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intra-canal cryotherapy on postoperative pain in single-visit endodontic retreatment: randomized clinical trial
Public title
Effect of intra-canal cryotherapy on postoperative pain in single-visit endodontic retreatment: randomized clinical trial
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients should be classified as ASA I or ASA II in terms of systemic health
The teeth should have no spontaneous pain
Teeth with periapical lesions or teeth with clear evidence of leakage.
Exclusion criteria:
Teeth that cannot create a glide path to the apical foramen due to canal blockage or previous treatment errors
Patients with chronic periapical abscess, sinus tract, internal or external resorption, periodontal problems
Pregnant patients
Patients with a history of trauma
Patients with Temporomandibular disorders
Patients who cannot take NSAIDs
Patients who have a history of taking antibiotics, analgesics and anti-inflammatory agents before treatment
Patients who smoke more than 10 cigarettes a day
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
46 sealed envelopes are prepared which contain a sheet to determine the patient group. Half of the envelopes belong to the cold therapy group and a half to the control group. The patient randomly chooses an envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
Before the treatment, the patient does not know which group he is in, and because of the anesthesia, he does not feel the cold caused by the irrigant during the treatment, and he will not notice his grouping.
The person in charge of data collection does not know which group each patient was in.
The person responsible for evaluating the data does not know what treatment each group received and only compares the group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Dentistry- Tehran University of Medical Sciences
Street address
Endodontics department, Tehran university of medical sciences school of dentistry, North Kargar
City
Tehran
Province
Tehran
Postal code
1439955991
Approval date
2022-08-22, 1401/05/31
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1401.072
Health conditions studied
1
Description of health condition studied
Post-operative pain after a single visit non-surgical root canal retreatment
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Post-operative pain on the scale of Numerical Rating Scale
Timepoint
6h-18h-24h-48h-72h-7d
Method of measurement
Numerical Rating Scale on the scale of 0-100
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients who undergo non-surgical root canal retreatment in one visit, at the end of the treatment, and before the obturation, the root canals are irrigated with normal saline 2-4 degrees Celsius
Category
Treatment - Other
2
Description
Control group: Patients who undergo non-surgical root canal retreatment under the same standard treatment as the intervention group, so that the only difference between the treatment process of the two groups is the normal saline temperature used for the final cleaning of the canal.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry- Tehran University of Medical Sciences
Full name of responsible person
Mohammad Mahdi Kiafar
Street address
Endodontics department, Tehran university of medical sciences school of dentistry, North Kargar
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 6636 9439
Email
m-kiafar@razi.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sholeh Ghabraei
Street address
Endodontics department, Tehran university of medical sciences school of dentistry, North Kargar
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 912 207 5034
Email
sholehghabraei@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Mahdi Kiafar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Endodontics
Street address
Endodontics department, Tehran university of medical sciences school of dentistry, North Kargar
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 6636 9439
Email
m-kiafar@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Mahdi Kiafar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Endodontics
Street address
Endodontics department, Tehran university of medical sciences school of dentistry, North Kargar
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 6636 9439
Email
m-kiafar@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Mahdi Kiafar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Endodontics
Street address
Endodontics department, Tehran university of medical sciences school of dentistry, North Kargar
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 6636 9439
Email
m-kiafar@razi.tums.ac.ir
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
Undecided - It is not yet known if there will be 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The amount of pain after treatment, the amount of painkillers consumed, age, sex, type of tooth
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
Universities and scientific and industrial institutions
Under which criteria data/document could be used
Using for systematic reviews on the subject or conducting similar research in this field or making related devices to reduce pain after treatment
From where data/document is obtainable
Endodontics department, Tehran university of medical sciences school of dentistry, North Kargar, postal code 1439955991
Mobile phone: 00989106498348
Email: m-kiafar@razi.tums.ac.ir
What processes are involved for a request to access data/document
Sending a written request with the mention of the university or institution requesting the information to the above address or via email or WhatsApp to the email or number listed and replying to the request after confirming the identity of the person making the request up to 1 month after receiving the request letter .