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CTRI Number  CTRI/2023/06/053912 [Registered on: 15/06/2023] Trial Registered Prospectively
Last Modified On: 13/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of sequential and continuous irrigation protocols on the healing of tooth with periapical pathology using clinical and radiographic evaluation.  
Scientific Title of Study   A comparative evaluation of clinical and radiographic periapical healing after continuous and sequential chelation irrigation protocols in teeth with periapical pathology – A Randomized Clinical Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  vinaya hanmant pisal 
Designation  post graduate student 
Affiliation  KM Shah Dental College and Hospital Sumandeep Vidyapeeth 
Address  room no 8 department of conservative dentistry and endodontics K M Shah Dental College and Hospital sumandeep vidyapeeth At and Po pipariya taluka waghodia Dist Vadodara gujarat 391760

Vadodara
GUJARAT
391760
India 
Phone  9607086688  
Fax    
Email  vinayapisal99@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Renu Batra 
Designation  professor and post graduate guide 
Affiliation  KM Shah Dental College and Hospital Sumandeep Vidyapeeth 
Address  room no 8 department of conservative dentistry and endodontics K M Shah Dental College and Hospital sumandeep vidyapeeth At and Po pipariya taluka waghodia Dist Vadodara gujarat 391760

Vadodara
GUJARAT
391760
India 
Phone  9537528008  
Fax    
Email  drrenubatra@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Renu Batra 
Designation  professor and post graduate guide 
Affiliation  KM Shah Dental College and Hospital Sumandeep Vidyapeeth 
Address  room no 8 department of conservative dentistry and endodontics K M Shah Dental College and Hospital sumandeep vidyapeeth At and Po pipariya taluka waghodia Dist Vadodara gujarat 391760

Vadodara
GUJARAT
391760
India 
Phone  9537528008  
Fax    
Email  drrenubatra@gmail.com  
 
Source of Monetary or Material Support  
room no 8 department of conservative dentistry and endodontics K M Shah Dental College and Hospital sumandeep vidyapeeth At and Po pipariya taluka waghodia Dist Vadodara gujarat 391760 
 
Primary Sponsor  
Name  Dr Vinaya Pisal 
Address  sumandeep vidyapeeth At and Po pipariya taluka waghodia Dist Vadodara gujarat 391760 
Type of Sponsor  Other [self funded] 
 
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 Vinaya Pisal  KM Shah Dental College and Hospital  Room no. 8 Department of Conservative Dentistry and Endodontics KM shah Dental College and Hospital sumandeep vidyapeeth At and Po pipariya taluka waghodia Dist Vadodara gujarat 391760
Vadodara
GUJARAT 		 9607086688

vinayapisal99@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumandeep Vidyapeeth Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: PCS||, (2) ICD-10 Condition: K045||Chronic apical periodontitis, (3) ICD-10 Condition: K045||Chronic apical periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  continuous chelation irrigation protocol  Continuous chelation irrigation protocol (2.5% NaOCl containing the freshly dissolved HEDP powder) NAOCL & ETIDRONATE IRRIGATION PREPRATION: Etidronate (Dual Rinse HEDP) comes in a capsule containing 0.9 g of etidronate powder, which will be mixed immediately with 10 mL of a 2.5% NaOCl solution directly before treatment, resulting in a combined irrigant containing both active chlorine and approximately 9% HEDP. Passive ultrasonic irrigation will be performed using Ultra X (Eighteeth) with 2.5% NaOCl & 9% HEDP solution for 20s, three times. Before each activation new solution will be flushed in canal. The total 10mL irrigant solution will be used in this irrigation protocol. Then the root canals will be flushed with 5 mL of Normal Saline for 1 min.  
Comparator Agent  sequential chelation irrigation protocol  the ‘sequential chelation’ protocol was introduced, in which  For final irrigation, passive ultrasonic irrigation will be performed using Ultra X (Eighteeth) with 2.5% NaOCl solution for 20s, three times. Before each activation new solution will be flushed in canal. To avoid potential carry-over effects by NaOCl, 2.5ml normal saline is irrigated, after that canals will be filled with 17% EDTA for 1-2 min and activated for 60s. The total 10mL of 2.5% NaOCl and 2.5 mL of 17% EDTA will be used in this irrigation protocol. Then the root canals will be flushed with 5 mL of Normal Saline for 1 min. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Healthy patients (Category: American Society of Anaesthesiologists class 1) (ASA House of Delegates 2014) aged between 18 – 60 years of age will be included.
2.Maxillary or mandibular teeth diagnosed with periapical pathology not more than 3mm (Periapical Index less than 4 given by Orstavik et al20) in dimension will be included.
3.Only those patients ready to sign the consent form will be included in the study.
 
 
ExclusionCriteria 
Details  1.Teeth with open apex, root resorption and calcified pulp chamber and canals will be excluded from the study.
2.Teeth with curvature more than 20 degree will be excluded from the study
3.Teeth which had received previous endodontic treatment will be excluded from the study.
4.Cases showing periodontal pockets deeper than 4mm will be excluded from the study.
5.Teeth with Flare ups during root canal treatment will be excluded from the study.
6.Any other iatrogenically affected root canal treatments will be excluded from the study.
7.Medically compromised patients will be excluded from the study.
 
 
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 
The result of the study will help us to determine the efficacy of sequential & continuous chelation irrigation protocols in a tooth with periapical pathology. Moreover, it will help practitioner to get better idea of both irrigation regimes.  The result of the study will help us to determine the efficacy of sequential & continuous chelation irrigation protocols in a tooth with periapical pathology. Moreover, it will help practitioner to get better idea of both irrigation regimes. This will be assessed at baseline, 3 months and 6 months. 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/07/2023 
Date of Study Completion (India) 20/06/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 20/06/2024 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [vinayapisal99@gmail.com].

  6. For how long will this data be available start date provided 30-11-2025 and end date provided 28-02-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

The outcome of endodontic treatment depends critically on the removal of microbes, necrotic tissues, and accumulated hard tissue debris which is mechanical instrumentation and strong antibacterial irrigation followed by well-sealed obturation of the root canal system can significantly reduce the bacterial load and create an environment conducive to healing.

Sodium Hypochlorite shows excellent antimicrobial and tissue dissolving properties but, to remove smear layer chelating agents are required. Combination of both (Continuous Chelation Irrigation) is best seen with mixture of 2.5% sodium hypochlorite and 9% HEDP solution.

As minimal literature is available on the clinical efficacy of continuous chelation irrigation protocols in teeth with periapical pathology. The present study compares the use of   2.5% sodium hypochlorite & 17% EDTA (sequential chelation irrigation) with solution of 2.5% sodium hypochlorite and 9% etidronate (HEDP) as root canal irrigant in teeth with periapical pathology.

Therefore, the aim of the study is to compare the clinical and radiographical evaluation of periapical healing of continuous and sequential chelation irrigation protocols in teeth with periapical pathology.

 
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