FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/10/046599 [Registered on: 18/10/2022] Trial Registered Prospectively
Last Modified On: 21/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   STUDY ON EFFECT OF COLD SALINE IRRIGATION ON POSTOPERATIVE PAIN AFTER ROOT CANAL TREATMENT 
Scientific Title of Study   Comparative evaluation of the effect of intracanal cryotreated saline and room temperature saline as a final irrigant on postoperative pain after root canal treatment A randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Snehal Shelke 
Designation  Postgraduate Student 
Affiliation  government dental college and hospital ,nagpur 
Address  Department of conservative dentistry and endodontics ,Governmemt dental college Napur
government dental college and hospital ,medical sqaure,hanumannagar,nagpur
Nagpur
MAHARASHTRA
440003
India 
Phone  94043452227  
Fax    
Email  snehalshelke3@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manjusha M Warhadpande 
Designation  Professor and Head of the department 
Affiliation  government dental college and hospital ,nagpur 
Address  117,Postgraduate section, department of conservative dentistry and endodontics, government dental college and hospital, Nagpur.
government dental college and hospital ,medical sqaure,hanumannagar,nagpur
Nagpur
MAHARASHTRA
440003
India 
Phone  9822087369  
Fax    
Email  manjushawarhadpande@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Snehal Shelke 
Designation  Postgraduate Student 
Affiliation  government dental college and hospital ,nagpur 
Address  117,Postgraduate section, department of conservative dentistry and endodontics, government dental college and hospital, Nagpur.
government dental college and hospital ,medical sqaure,hanumannagar,nagpur
Nagpur
MAHARASHTRA
440003
India 
Phone  94043452227  
Fax    
Email  snehalshelke3@gmail.com  
 
Source of Monetary or Material Support  
Government Dental College and Hospital, Nagpur. 
 
Primary Sponsor  
Name  Dr snehal shelke 
Address  krishnamai hospital at post ambavade tal katav satara 
Type of Sponsor  Other [self sponsered] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
dr snehal shelke  Government Dental College and Hospital,Nagpur  117,Postgraduate Section ,Department of Conservative Dentistry And Endodontics
Nagpur
MAHARASHTRA 		 9404352227

snehalshelke3@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics comitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  cold temprature normal saline  20 ml of cold temprature saline 2 - 4 degree centigrade temprature for irrigation of root canals for 4 minutes. 
Comparator Agent  room temprature saline  20 ml of 25-30 degree centigrade temperature saline for root canal irrigation for 4 minutes. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. The age group of 18–50 years who signed the informed consent.
2. The patient requiring endodontic therapy.
3. Mandibular premolars diagnosed with symptomatic irreversible pulpitis with apical periodontitis.
4. Healthy patients without any systemic disease.
5. Patients with pain score ranging from moderate to severe (4–10) on a visual analog scale (VAS).
 
 
ExclusionCriteria 
Details  1. Patients who are medically compromised.
2. Pregnant patients.
3. Teeth with incomplete apex formation.
4. Teeth with calcified canals.
5. Teeth with Sinus opening.
6. Teeth with periapical abscess.
7. Patients on antibiotic therapy.
8. Patients on analgesics on the day of treatment.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
reduction in postoperative pain  reduction in postoperative pain after 6 hours,12 hours,24 hours,48 hours and 1 week 
 
Secondary Outcome  
Outcome  TimePoints 
pain reduction in intervention group when compared to control group using visual analouge scale.  6 hours,12hours,24 hours,48 hours,1 week 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   30/11/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [snehalshelke3@gmail.com].

  6. For how long will this data be available start date provided 30-12-2023 and end date provided 30-12-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Pain is an unwanted yet unfortunately common sensation after root canal treatment. which commences a few hours or days after treatment and is always an unpleasant experience for both patients and clinicians.In 2016, cryotherapy was first clinically used in endodontics by Keskin et al for minimizing postoperative pain after single-visit root canal treatment. Their study included teeth with vital inflamed pulps; however, they did not differentiate between asymptomatic and symptomatic pulpitis nor did they differentiate between cases with and without apical periodontitis.Other studies following the same protocol presented by Vera et al affirmed that cryotherapy reduced postoperative pain after single-visit root canal treatment in teeth with vital pulps.Nevertheless, extirpation of the inflamed pulp in irreversible pulpitis where the inflammation is confined within the pulp and did not extend into the periapical tissue is usually proceeded by patient relief so the direct effect of cryotherapy on reducing postoperative pain could not be established in this case.Therefore the purpose of this study is to evaluate and compare the effect of cryotreated saline and room temperature saline as a final irrigant on pain after single visit root canal treatment in patients with vital inflamed pulp with apical periodontitis. 
Close