Protocol summary
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Study aim
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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.
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Design
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A two-armed randomized clinical trial with a control group, double-blind (patient and researcher responsible for data analysis), on 46 patients.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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
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Main outcome variables
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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
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Reason for update
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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.
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Acronym
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IRCT registration information
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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
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Registration date
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2022-12-19, 1401/09/28
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-09-23, 1401/07/01
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Expected recruitment end date
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2023-02-20, 1401/12/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect of intra-canal cryotherapy on postoperative pain in single-visit endodontic retreatment: randomized clinical trial
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Public title
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Effect of intra-canal cryotherapy on postoperative pain in single-visit endodontic retreatment: randomized clinical trial
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
46
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-08-22, 1401/05/31
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Ethics committee reference number
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IR.TUMS.DENTISTRY.REC.1401.072
Health conditions studied
1
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Description of health condition studied
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Post-operative pain after a single visit non-surgical root canal retreatment
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Post-operative pain on the scale of Numerical Rating Scale
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Timepoint
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6h-18h-24h-48h-72h-7d
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Method of measurement
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Numerical Rating Scale on the scale of 0-100
Intervention groups
1
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Description
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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
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Category
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Treatment - Other
2
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Description
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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.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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The amount of pain after treatment, the amount of painkillers consumed, age, sex, type of tooth
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When the data will become available and for how long
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6 months after the results are published
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To whom data/document is available
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Universities and scientific and industrial institutions
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Under which criteria data/document could be used
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Using for systematic reviews on the subject or conducting similar research in this field or making related devices to reduce pain after treatment
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From where data/document is obtainable
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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
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What processes are involved for a request to access data/document
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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 .
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Comments
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