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CTRI Number  CTRI/2025/12/098797 [Registered on: 10/12/2025] Trial Registered Prospectively
Last Modified On: 09/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry
Other (Specify) [IRRIGANT]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative Evaluation Of Post Endodontic Pain Using Two Different Volumes Of Plain Saline  
Scientific Title of Study   Comparative Evaluation Of Post Endodontic Pain After Intracanal Cryotherapy Using Two Different Volumes Of Plain Saline In Single Visit Root Canal Treatment – An InVivo study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Pranita Ingle 
Designation  student 
Affiliation  VSPM DENTAL COLLEGE NAGPUR 
Address  VSPM Dental College and Research Center, Digdoh Hingna Nagpur.
VSPM Dental College and Research Center, Digdoh Hingna Nagpur.
Nagpur
MAHARASHTRA
440019
India 
Phone  7499760391  
Fax    
Email  pranitaingle305@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Rajesh Kubde 
Designation  Professor 
Affiliation  VSPM DENTAL COLLEGE NAGPUR 
Address  VSPM Dental College and Research Center,Digdoh Hills Hingna Nagpur.

Nagpur
MAHARASHTRA
440019
India 
Phone  9881199669  
Fax    
Email  drkubderajesh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Pranita Ingle 
Designation  student 
Affiliation  VSPM DENTAL COLLEGE NAGPUR 
Address  VSPM Dental College and Research Center,Digdoh Hills Hingna Nagpur.

Nagpur
MAHARASHTRA
440019
India 
Phone  7499760391  
Fax    
Email  pranitaingle305@gmail.com  
 
Source of Monetary or Material Support  
VSPM DENTAL COLLEGE DIGDOH HILLS HINGNA NAGPUR, COUNTRY- INDIA Pin Code- 440019 
 
Primary Sponsor  
Name  SELF 
Address  Nil 
Type of Sponsor  Other [Nil] 
 
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 
Pranita Ingle  VSPM DENTAL COLLEGE DIGGDOH HILLS HINGNA NAGPUR  DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS
Nagpur
MAHARASHTRA 
7499760391

pranitaingle305@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  2.5 degree celsius saline  10 mili litre 
Intervention  SALINE VOLUME  5MILLILITER Frequency OF INTERVENTION is once  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Aged 18 to 60 will be included in the study.
2. Both male and female.
3. Systemically healthy patients (Category: American Society of Anesthesiologists class 1).
4. Single rooted tooth indicated for single visit root canal treatment.
5. Ability to read and comprehend the visual analogue scale (VAS) sheets and informed consent.
6. Having no history of painkillers administrated with 12 hours before procedure.
 
 
ExclusionCriteria 
Details  1. Teeth with crown/root fractures
2. Medically compromised patients
3. Compromised periodontium and open apices
4. Patient taken analgesic
5. Pregnant or lactating women
6. Previously treated/initiated root canal treatment
7. Retreatment cases.
 
 
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 
1) To Evaluate the Effect of Post Endodontic Pain After Intracanal Cryotherapy Using Two Different Volumes Of Plain Saline In Single Visit Root Canal Treatment  48 hrs 
 
Secondary Outcome  
Outcome  TimePoints 
2) To Compare the Effect of Post Endodontic Pain After Intracanal Cryotherapy Using Two Different Volumes Of Plain Saline In Single Visit Root Canal Treatment
3) To analyse the Effect of Post Endodontic Pain After Intracanal Cryotherapy Using Two Different Volumes Of Plain Saline In Single Visit Root Canal Treatment

 
48 hrs 
 
Target Sample Size   Total Sample Size="39"
Sample Size from India="39" 
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 2 
Date of First Enrollment (India)   25/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  25/12/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

One of the most essential parts of endodontic practice is the management of postoperative pain and discomfort, which patients regularly complain after receiving endodontic treatment(1). Postoperative pain is unpleasant and is described as discomfort experienced by patients; it has a high incidence rate ranging between 3% - 58%, and tends to worsen between the initial 6 - 12 hours after treatment, peaking at around 40% in 24 hours and then declining to 11% in one week (2,3). The likely causes of postoperative discomfort may be mechanical, chemical, and/or microbiological damage to the periradicular tissues (2). This sometimes causes periapical irritation, also known as flareup.

Cryotherapy, often known as cold therapy , where the surrounding temperature of tissues is being lowered to relive pain. It has been widely used in sports injuries and surgical operations to reduce pain and provide postoperative care (12, 13). (2)Cryotherapy has been shown to reduce inflammation, oedema, pain, and reduces the recovery time in short-term orthopedic, abdominal, gynecological, and hernia procedures. (1) Low temperatures cause vasoconstriction, also it reduces pain by blocking nerve terminals [11]. (2) Vasoconstriction , decreases the release of inflammatory enzymes, it slow down the cell metabolism, lowering oxygen demand and limiting free radical generation in tissues (22).

 

In dentistry, cryotherapy has already been adopted by professionals, especially for postoperative pain control after surgical procedures. . (4)The temperature of the outer surface of the root can be reduced more than 10 C by using cold saline (2.5 C) for 5 min and has an anti-inflammatory effect on the periradicular tissue. (3)The first clinical investigation on the use of intracanal cryotherapy in pain control was undertaken by Al-Nahlawi et al., (10) using cold saline (2- 40 C), and observed considerable pain reduction.

 

Although the effectiveness of cryotherapy has been well established in the literature, there is no standardization of the type or volume of the cryoagent used, mode of application, or duration to identify an ideal protocol for this treatment. Therefore, the purpose of this study was to evaluate the effect of dual volume irrigation as a final irrigant following biomechanical preparation of root canals on postoperative pain in patients with irreversible pulpitis.

 
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