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CTRI Number  CTRI/2025/07/090335 [Registered on: 07/07/2025] Trial Registered Prospectively
Last Modified On: 01/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Does using cold saline for final rinse reduces pain in children undergoing pulpectomy 
Scientific Title of Study   Comparative evaluation of intracanal Saline as final irrigation at 2-4°C and 13-15°C Versus Room-Temperature on Post-Operative Pain over 48 Hours in Single visit Pulpectomy: A Parallel three arm Randomized Clinical Trial.  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Palakjeet Kaur Rissam 
Designation  Junior Resident 
Affiliation  AIIMS RAIPUR 
Address  Department of dentistry, C- block AIIMS RAIPUR


CHHATTISGARH
492099
India 
Phone  9682519663  
Fax    
Email  mepalakjeetrissam24@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Virat Galhotra 
Designation  Professor, HOD Department of Dentistry 
Affiliation  AIIMS RAIPUR 
Address  Department of Dentistry C block AIIMS RAIPUR

Raipur
CHHATTISGARH
492099
India 
Phone  9216274600  
Fax    
Email  virat@aiimsraipur.edu.in  
 
Details of Contact Person
Public Query  
Name  Palakjeet Kaur Rissam 
Designation  Junior Resident 
Affiliation  AIIMS RAIPUR 
Address  Department of Dentistry C block AIIMS RAIPUR


CHHATTISGARH
492099
India 
Phone  9682519663  
Fax    
Email  mepalakjeetrissam24@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Raipur Tatibandh, Raipur, Chhattisgarh 492099 
 
Primary Sponsor  
Name  All India Institute Of Medical Sciences Raipur 
Address  All India Institute Of Medical Sciences,Raipur, G E Road Tatibandh, Chhattisgarh 492099 
Type of Sponsor  Research institution and hospital 
 
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 
Palakjeet Kaur Rissam  All India Institute of Medical Sciences , Raipur  Department of Dentistry C-Block Ground Floor Gate no 4 AIIMS Raipur, Tatibandh 492099 Raipur Chhattisgarh
Raipur
CHHATTISGARH 		 09682519663

mepalakjeetrissam24@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute of Ethics Committee, AIIMS Raipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Crotherapy final irrigation  Cold Saline final irrigation at two Cryotherapy temperatures of 2-4 and 13 to 15 degrees. 
Comparator Agent  Room temperature saline  Room temperature saline as final irrigation 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  Children aged 4–8 years requiring pulpectomy in primary molars.
Primary molars with irreversible pulpitis both symptomatic and asymptomatic
but with restorable crown structure.
Roots showing minimal root resorption
Medically healthy children ASA Class I with no systemic diseases that could
affect pain perception or healing.
Children whose parents/guardians are willing to give consent for participation
in the study and post operative pain assessment via video calling.
Children classified as Frankl’s positive or definitely positive 3 or 4 to ensure
successful treatment completion. 
 
ExclusionCriteria 
Details  Primary molars with severe carious destruction, periapical pathology causing
extensive bone loss, or furcation involvement.
Less than 2/3rd of the root intact.
Children with bleeding disorders, special healthcare needs,
immunocompromised conditions, or congenital heart diseases requiring
antibiotic prophylaxis. Children taking anti-inflammatory or analgesic
medications within 24 hours before treatment.
• Children with uncooperative behaviour (Frankl’s negative or definitely
negative: 1 or 2) that may interfere with the study procedure.
• Any known allergy to local anaesthetics, medicaments, or irrigation solutions
used in the study.
• Children whose parents/guardians are not willing to give consent for
participation in the study and post operative pain assessment via video calling.
Cases with obturation material extruded beyond the apex.
Gingival laceration owing to rubber dam clamp placement.  
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
postoperative pain reduction among patients undergoing single-visit pulpectomy
using two different cryotherapy temperatures versus room-temperature saline as final
intracanal irrigation  		 preoperative, 6, 12, 24,48 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Post operative analgesic requirement  preoperative, 6, 12, 24,48 hours 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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/ Phase 3 
Date of First Enrollment (India)   24/07/2025 
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)   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   This randomized, double-blinded clinical trial aims to assess whether using cold saline as a final irrigant during single-visit pulpectomy reduces post-operative pain in children aged 4 to 8 years. The study involves 66 participants divided equally into three groups: one receiving room-temperature saline, and the other two receiving saline cooled to 2–4°C and 13–15°C, respectively. All children undergo standard pulpectomy procedures, including anesthesia, rubber dam isolation, caries removal, canal instrumentation, and irrigation. Final irrigation is performed with 20 ml of saline for 5 minutes, with temperature maintained using thermal flasks and verified with thermometers. To collect pain data, the Wong-Baker Faces Pain Scale is used, which helps children communicate pain intensity by pointing to facial expressions. Each participant’s guardian receives a pain assessment form to record the child’s pain levels at 6, 12, 24, and 48 hours post-operatively. These recordings are confirmed through scheduled video calls with a blinded evaluator to ensure accuracy and reduce recall bias. Additional forms include the patient information sheet, informed consent form, and case record form. The study also tracks whether pain medication was needed. The expected outcome is a reduction in post-operative pain and analgesic requirement in both cryotherapy groups compared to the control group. 
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