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CTRI Number  CTRI/2022/09/045537 [Registered on: 15/09/2022] Trial Registered Prospectively
Last Modified On: 07/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluation of post operative pain with different root canal cleaning methods 
Scientific Title of Study   Comparative Evaluation of Three Irrigation Techniques on Causing Post Operative Pain in Single Rooted Teeth with Symptomatic Irreversible Pulpitis or Apical Periodontitis : 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 PRAVIN KUMAR 
Designation  Professor and Head 
Affiliation  All India Institute of Medical Sciences Jodhpur  
Address  Department of Dentistry Block 2A OPD Building All India Institute of Medical Sciences Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  9818402220  
Fax    
Email  kumarpr@aiimsjodhpur.edu.in  
 
Details of Contact Person
Scientific Query  
Name  DR PRAVIN KUMAR 
Designation  Professor and Head 
Affiliation  All India Institute of Medical Sciences Jodhpur  
Address  Department of Dentistry Block 2A OPD Building All India Institute of Medical Sciences Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  9818402220  
Fax    
Email  kumarpr@aiimsjodhpur.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Sumit Kumar Yadav 
Designation  Post Graduate Student 
Affiliation  All India Institute of Medical Sciences Jodhpur  
Address  Room number 207 Endodontic Section Department of Dentistry Block 2A OPD Building All India Institute of Medical Sciences Jodhpur

Jodhpur
RAJASTHAN
342005
India 
Phone  8802070244  
Fax    
Email  sumityadav49@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences 
Address  Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni, Jodhpur, Rajasthan 342005 
Type of Sponsor  Government medical college 
 
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 PRAVIN KUMAR  All India Institute of Medical Sciences   Room number 208 Endodontic Section Block IIA Second Floor Department of Dentistry Marudhar Industrial Area, 2nd Phase, M.I.A. 1st Phase, Basni, Basni, Jodhpur, Rajasthan 342005
Jodhpur
RAJASTHAN 		 9818402220

kumarpr@aiimsjodhpur.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee AIIMS Jodhpur  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, (2) ICD-10 Condition: K045||Chronic apical periodontitis, (3) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional side vented needle   Irrigation will be done through a 30-G side port needle during canal preparation and the remaining solution will be flushed into canals with 2 mm short of the working length verified by rubber stops. The final irrigation will be performed with 5 mL 17 % EDTA followed by 10 mL distilled water. The total duration of intervention will be approximately 30 minutes.  
Intervention  Endoactivator  After completion of canal preparation, EndoActivator will be used into the canal 2mm short of the working length and NaOCl will be replenished after every one minute until the remaining of NaOCl used completely. The final irrigation will be performed with 5 mL 17 % EDTA followed by 10 mL distilled water. The total duration of intervention will be approximately 30 minutes.  
Intervention  Endovac  During canal preparation, the master delivery tip and macro-cannula will be used to flush out gross debris. Apical third of root will be cleaned using microcannula tip being placed at the full working length in a pecking motion until the remaining solution used completely and followed by final irrigation will be performed with 5 mL 17 % EDTA followed by 10 mL distilled water. The total duration of intervention will be approximately 30 minutes.  
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Healthy persons(ASA I) between the age group of 16 years to 65 years
2. Single rooted teeth diagnosed with symptomatic irreversible pulpitis and apical periodontitis
3. Patients with preoperative pain score ranging from moderate to severe (45–100 mm) on a visual analog scale (VAS, 0–100 mm)
 
 
ExclusionCriteria 
Details  1. Patients who had taken analgesic or anti-inflammatory drugs within the last 12 hours
2. Pregnancy or lactation
3. Teeth with calcified canals
4. Teeth with periodontal diseases
5. Teeth with root resorption
6. Teeth with immature/open apex
7. Previously treated or initiated tooth
 
 
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 
To comparatively evaluate the incidence and intensity of post-operative pain using positive pressure, negative pressure and sonic activated irrigation following single visit root canal therapy.  6, 24, 48, and 72 hours after treatment 
 
Secondary Outcome  
Outcome  TimePoints 
To comparatively evaluate the positive pressure, negative pressure irrigation technique and sonic activated irrigation on requirement/prescription of analgesics for post-operative pain following single visit root canal therapy.  6, 24, 48, and 72 hours after treatment 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
Final Enrollment numbers achieved (Total)= "48"
Final Enrollment numbers achieved (India)="48" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   19/09/2022 
Date of Study Completion (India) 30/06/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Chemo-mechanical debridement of the root canal aims to remove pulpal tissues, microorganisms and their by-products, and debris using endodontic instruments and irrigants. Endodontic irrigant reduces the friction between the instrument and dentin; improves the cutting effectiveness of the files used; dissolves tissue; cools the file and tooth; and, furthermore, it has both a washing effect and an antimicrobial/antibiofilm effect. Irrigants have traditionally been delivered into the root canal space using syringes and metal needles of different sizes and tip designs. Many irrigation devices have been developed with the aim of improving the irrigant delivery throughout the root canal by using ultrasonic or sonic energy and apical negative pressure. One of the important aspects of root canal therapy is to control pain after treatment. Postoperative pain is an unwanted yet unfortunately common sensation after endodontic treatment. The incidence of postoperative pain was reported to range from 3% to 58%. There is no single factor affecting pain after root canal treatment and it may be due to mechanical, chemical and/or microbial injury to the pulp or periradicular tissues. Irrigating solutions or medications can evoke pain by irritating the periradicular tissues. The root canal irrigation method could affect the amount of apically extruded debris or irrigants. Any irrigation delivery system that reduces the risk of extrusion into periapical tissues would help the patient and the clinician because such a system could decrease postoperative discomfort. 

Thus, the present clinical trial aims to comparatively evaluate the three irrigation techniques on causing post operative pain in symptomatic irreversible pulpitis/ apical periodontitis following single visit root canal therapy. 

 
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