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CTRI Number  CTRI/2025/12/099478 [Registered on: 19/12/2025] Trial Registered Prospectively
Last Modified On: 18/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Do Different Root Canal Sealers Affect Pain Relief and Healing After Treatment? 
Scientific Title of Study   Comparative analysis of post operative pain and healing of periapical lesion using different sealers after non surgical endodontic treatment. A randomized controlled 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 Prashanth S 
Designation  Post Graduate Student 
Affiliation  Government Dental College and Hospital,Nagpur 
Address  117, DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS, GOVERNMENT DENTAL COLLEGE AND HOSPITAL,NAGPUR
117, DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS, GOVERNMENT DENTAL COLLEGE AND HOSPITAL,NAGPUR
Nagpur
MAHARASHTRA
400003
India 
Phone  9342522537  
Fax    
Email  sankardrprashant@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sadhana Raina 
Designation  Associate Professor  
Affiliation  Government Dental College and Hospital,Nagpur 
Address  117, DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS, GOVERNMENT DENTAL COLLEGE AND HOSPITAL,NAGPUR
117, DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS, GOVERNMENT DENTAL COLLEGE AND HOSPITAL,NAGPUR
Nagpur
MAHARASHTRA
400003
India 
Phone  9423685967  
Fax    
Email  drsadhanaraina@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sadhana Raina 
Designation  Associate Professor  
Affiliation  Government Dental College and Hospital,Nagpur 
Address  117, DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS, GOVERNMENT DENTAL COLLEGE AND HOSPITAL,NAGPUR
117, DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS, GOVERNMENT DENTAL COLLEGE AND HOSPITAL,NAGPUR
Nagpur
MAHARASHTRA
400003
India 
Phone  9423685967  
Fax    
Email  drsadhanaraina@gmail.com  
 
Source of Monetary or Material Support  
117, Department of Conservative Dentistry and endodontics, Government dental college and hospital,Nagpur, Maharashtra 440003 ,India 
 
Primary Sponsor  
Name  DR PRASHANTH S 
Address  DENTISTRY AND ENDODONTICS, GOVERNMENT DENTAL COLLEGE AND HOSPITAL,NAGPUR 
Type of Sponsor  Other [SELF SPONSORED] 
 
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 
PRASHANTH S  GOVERNMENT DENTAL COLLEGE AND HOSPITAL, NAGPUR  117,DEPARTMENT OF CONSERVATIVE DENTISTRY AND ENDODONTICS, GOVERNMENT DENTAL COLLEGE AND HOSPITAL,NAGPUR
Nagpur
MAHARASHTRA 
9342522537

sankardrprashanth@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee,government dental college and hospital,nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K041||Necrosis of pulp,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ENDOFILL  PD Endofill (also referred to simply as Endofill) is a well-known radiopaque, zinc oxide-eugenol based root canal sealer containing dexamethasone for permanent obturation after a pulpectomy. The addition of dexamethasone provides anti-inflammatory properties to help reduce post-operative pain and sensitivity.  
Intervention  MTA FILLAPEX  MTA Fillapex is an endodontic sealer, while MTA Reparative is indicated for the treatment of perforations, root resorption, apical plug and pulp capping. 
Comparator Agent  ZINC OXIDE EUGENOL  Zinc oxide eugenol (ZOE) is a widely used material in dentistry, primarily as a root canal (RC) sealer, temporary cement, or cavity liner. It is a powder/liquid system that reacts to form an amorphous chelate of zinc eugenolate.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. HEALTHY PATIENTS BETWEEN 18-60 YEARS
2. PAI SCORE 2 OR MORE 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
This randomised control clinical study is designed to analyse and compare the mentioned sealers in terms of their role in post-operative pain and peri-apical healing potential.To check in reduction of Post-operative pain intensity   3 months, 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Radiographic healing of periapical lesion  24 hours,48 hours & 7 days 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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 3 
Date of First Enrollment (India)   29/12/2025 
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  

Post-operative pain has a multi-factorial aetiology and a potential pathogenic link to the acute inflammation of the periapical area, secondary to localized chemical, mechanical, host and/or microbial damage occurring during endodontic treatment.

Postoperative pain is a usual and unpredictable outcome of endodontic treatment. Postoperative pain after RCT has been reported from 1.9%- 48%. Apical extrusion of debris (AED) or excessive apical region preparation are typically the causes of post-operative pain associated with RCT.Incomplete pulp removal, apical extrusion of the obturating material, chemical irritation, root fracture, and incorrect filling adjustment are other reasons for postoperative pain. Traditionally, gutta-percha combined with an endodontic sealer is used to fill root canal systems that need to be treated. Although these sealers are intended to be used inside the root canal during endodontic therapy, they may leach, lateral canal, or get into close contact with the periapical tissues.Sealers placed in the root canal may interfere with periodontal tissues through the apical foramen, lateral canals and can possibly affect the healing process in the periodontium. The severity of  inflammatory reactions is influenced by a variety of factors including the root canal sealers composition. In addition to this,root canal sealer might activate the trigeminal nociceptors invitro and this activation along with immunologic response may trigger pain symptoms and can cause flare up


 
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