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CTRI Number  CTRI/2025/03/082769 [Registered on: 19/03/2025] Trial Registered Prospectively
Last Modified On: 25/02/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Evaluation of pain after single visit root canal treatment using different temperatures and concentrations of disinfecting solution. 
Scientific Title of Study   Evaluation Of The Effect Of Irrigation With Sodium Hypochlorite At Different Concentration And Temperature On Post Operative Pain In Mandibular Molars With Irreversible Pulpitis : A 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  Dr Ankita Sharma 
Designation  Reader 
Affiliation  Shree Guru Govind Singh Tricentanary University 
Address  SGT university, Gurgaon Badli Road, Gurugram -122505

Gurgaon
HARYANA
122505
India 
Phone  9682575180  
Fax    
Email  Ankita_fds@sgtuniversity.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Ankita Sharma 
Designation  Reader 
Affiliation  Shree Guru Govind Singh Tricentanary University 
Address  SGT university, Gurgaon Badli Road, Gurugram -122505

Gurgaon
HARYANA
122505
India 
Phone  9682575180  
Fax    
Email  Ankita_fds@sgtuniversity.org  
 
Details of Contact Person
Public Query  
Name  Dr Ankita Sharma 
Designation  Reader 
Affiliation  Shree Guru Govind Singh Tricentanary University 
Address  SGT university, Gurgaon Badli Road, Gurugram -122505

Gurgaon
HARYANA
122505
India 
Phone  9682575180  
Fax    
Email  Ankita_fds@sgtuniversity.org  
 
Source of Monetary or Material Support  
SGTDental College, Gurugram, Haryana 
 
Primary Sponsor  
Name  SGT Dental College 
Address  SGT University, Gurgaon Badli Road, Gurugram 122505 
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 
Dr Ankita Sharma  SGT Hospital   Room no. 204 , Dept. of Conservative Dentistry and Endodontics
Gurgaon
HARYANA 		 9682575180

ankita_fds@sgtuniversity.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE-SGT Dental College, Hospital and Research Institute   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  irrigation With Sodium Hypochlorite   Irrigation With 5.25% sodium hypochlorite at room temperature  
Intervention  Irrigation with sodium hypochlorite   Irrigation with sodium hypochlorite at different temperatures and different concentrations. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients aged 20-60 years.
Mandibular molars with irreversible pulpitis.
No previous history of endodontic treatment.
Non-contributory medical history.
 
 
ExclusionCriteria 
Details  Teeth with poor periodontal status.
Patients with Periapical Abscess, Sinus Tracts, Intraoral Swelling, Apical Periodontitis.
Re-treatment cases.
Patients who have received NSAIDs or Antibiotics in three months before the study.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
comparison and evaluating the effect of irrigation with sodium hypochlorite at different concentrations (1% and 3%) and temperatures (45 °C and 60 °C) on postoperative pain in mandibular molars with irreversible pulpitis.  6 hours, 12 hours, 24 hours, 48 hours , and 72 hours 
 
Secondary Outcome  
Outcome  TimePoints 
a) To evaluate & compare the effect of heated 1% NaOCl at 45 ° C & 60 °C on post operative pain in mandibular molars
b)To evaluate & compare the effect of heated 3% NaOCl at 45 ° C & 60 ° C on post operative pain in mandibular molars
c)To evaluate & compare the effect of heated 1% NaOCl & 3 % NaOCl on post operative pain in mandibular molars
d)To evaluate & compare the effect of temperature (45 °C & 60 °C) of NaOCl on postoperative pain in mandibular molars.
 		 at every 6 hours for three days 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   31/03/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 study is a randomized, parallel, multiple arm clinical trial which will be conducted in the department of conservative dentistry and endodontics, SGT dental college, Gurugram. It will compare the effect of irrigation with sodium hypochlorite at different temperatures and different concentrations on post operative pain in mandibular molars with irreversible pulpitis. The primary outcome of this study is to evaulate the post operative pain at 6 , 12, 24 , 48, 72 hours. 
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