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CTRI Number  CTRI/2025/04/085571 [Registered on: 24/04/2025] Trial Registered Prospectively
Last Modified On: 21/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of different irrigant activation systems on biomarkers and postoperative pain levels in symptomatic irreversible pulpitis patients  
Scientific Title of Study   Effect of different irrigant activation systems on GCF levels of NLRP3 and substance P and postoperative pain in patients with symptomatic irreversible pulpitis: A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
EC/NEW/INST/2023/HR/0266  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Smita Singh 
Designation  Post Graduate Student 
Affiliation  Manav rachna dental college 
Address  Manav rachna dental college, Sector – 43, Suraj Kund Badkhal Road, MRIIRS, Faridabad, Haryana

Faridabad
HARYANA
121004
India 
Phone  9335212126  
Fax    
Email  smitasingh556677@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Monika Tandan 
Designation  Professor and head of department, Conservative dentistry and Endodontics 
Affiliation  Manav rachna dental college 
Address  Manav rachna dental college, Sector – 43, Suraj Kund Badkhal Road, MRIIRS, Faridabad, Haryana

Faridabad
HARYANA
121004
India 
Phone  9999063631  
Fax    
Email  monikatandan.sds@mrei.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Smita Singh 
Designation  Post Graduate Student 
Affiliation  Manav rachna dental college 
Address  Manav rachna dental college, Sector – 43, Suraj Kund Badkhal Road, MRIIRS, Faridabad, Haryana

Faridabad
HARYANA
121004
India 
Phone  9335212126  
Fax    
Email  smitasingh556677@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Smita Singh 
Address  Manav rachna dental college, Sector – 43,Delhi, Suraj Kund Badkhal Rd, Faridabad, Haryana 121004 
Type of Sponsor  Other [Self] 
 
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 Smita Singh  Manav Rachna Dental College  Room No. 7, Department of Conservative dentistry and Endodontics, Manav rachna dental college, Sector 43, Faridabad, Haryana, 121004
Faridabad
HARYANA 		 09335212126

smitasingh556677@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: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional irrigation   Irrigation will be done with conventional irrigation method using a 31G single port side vented needle 3 mL of 3% NaOCl will be delivered subsequently into prepared canal. And 17% ethylenediaminetetraacetic acid (EDTA) will be used as a final irrigant for 1 min 
Intervention  Laser Activation  The irrigant will be activated in a sequence of 5 mL of 3% NaOCl followed by 2 mL of 17% EDTA The irrigant will be dispensed into the prepared canal using a 31G single port side vented needle Biolase Diode will be used for irrigant activation, water and air will be turned off during the procedure 
Intervention  Ultrasonic Activation  Irrigant will be dispensed into the canal using a 31G single port side vented needle The final irrigant activation will be done using piezoelectric ultrasonic unit at a power setting of 5 while placing 2 mm short of working length. 3 mL of 3% NaOCl will be used for each activation cycle for 30 s for a total of two cycles 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Male or female individuals aged 16–50 years.
2. Selected teeth - Single rooted mandibular Premolar diagnosed with symptomatic irreversible pulpitis.
3. Teeth with no canal curvature
 
 
ExclusionCriteria 
Details  1. Patients who needed antibiotic prophylaxis in last 3 month
2. Patients with any systemic disease
3. Pregnant females during treatment
4. Patients with intense plaque or calculus on the teeth, redness and bleeding in the gingiva, severe gingivitis, generalized periodontitis, or more than a 3-mm gingival pocket depth will not be included in this study 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Reduction in pain levels  0hr, 6hr, 12h, 24h, 48h, 72h and 7th day 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in inflammatory biomarkers level  0hr and 7th day 
 
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 4 
Date of First Enrollment (India)   05/05/2025 
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="1" 
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 randomized parallel group, active controlled trial will compare the effects of two irrigant activation systems (ultrasonic activation and laser activation) versus conventional syringe irrigation on inflammatory biomarker levels and postoperative pain in patients with symptomatic irreversible pulpitis undergoing root canal treatment. We hypothesize that activated irrigation will achieve a greater reduction in key inflammatory markers (NLRP3 and substance P) and result in lower postoperative pain scores compared to syringe irrigation. A total sixty patients will be randomized equally into three arms. Primary outcome include pain intensity at 0hr, 6hr ,12hr ,24hr, 48hr, 72hr and 7th day , daily analgesic consumption and patients reported comfort and satisfaction at day 7. And secondary outcome are the changes in biomarker level at 0hr and 7th day. No prior publication exist for this protocol. 
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