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CTRI Number  CTRI/2025/05/086426 [Registered on: 06/05/2025] Trial Registered Prospectively
Last Modified On: 24/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of Pain After Root Canal Treatment Using Two Different Sealers and Canal Tapers 
Scientific Title of Study   Comparison of Postoperative Pain in Single-Rooted Teeth With Asymptomatic Apical Periodontitis Using Two Bioceramic Sealers and Two Different Root Canal Tapers: A Single-Blind 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 Poornima Wazarkar 
Designation  PG Student 
Affiliation  Bharati Vidyapeeth Dental College and Hospital, Navi Mumbai 
Address  Room no 302, 3rd floor, Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Dental College and Hospital, Sector 7, CBD Belapur, Navi Mumbai

Thane
MAHARASHTRA
400614
India 
Phone  7020408705  
Fax    
Email  wazarkar.poornima@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rahul Rao 
Designation  Professor 
Affiliation  Bharati Vidyapeeth Dental College and Hospital, Navi Mumbai 
Address  Room no 302, 3rd floor, Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Dental College and Hospital, Sector 7, CBD Belapur, Navi Mumbai

Thane
MAHARASHTRA
400614
India 
Phone  9820094178  
Fax    
Email  drrahulrao25@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Poornima Wazarkar 
Designation  PG Student 
Affiliation  Bharati Vidyapeeth Dental College and Hospital, Navi Mumbai 
Address  Room no 302, 3rd floor, Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Dental College and Hospital, Sector 7, CBD Belapur, Navi Mumbai

Thane
MAHARASHTRA
400614
India 
Phone  7020408705  
Fax    
Email  wazarkar.poornima@gmail.com  
 
Source of Monetary or Material Support  
Dr Poornima Wazarkar Room no 302, 3rd floor, Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Dental College and Hospital, Sector 7, CBD Belapur, Navi Mumbai, Maharahtra, India 400614  
 
Primary Sponsor  
Name  Dr Poornima Wazarkar 
Address  Room no 302, 3rd floor, Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Dental College and Hospital, Sector 7, CBD Belapur, Navi Mumbai 400614 
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 Poornima Wazarkar  Bharati Vidyapeeth Dental College and Hospital, Sector 7, CBD Belapur, Navi Mumbai  Room no 302, 3rd floor, Department of Conservative Dentistry and Endodontics, Bharati Vidyapeeth Dental College and Hospital, Sector 7, CBD Belapur, Navi Mumbai 400614
Thane
MAHARASHTRA 
7020408705

wazarkar.poornima@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Bharati Vidyapeeth (Deemed to be University) Dental College and Hospital, Navi Mumbai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K045||Chronic apical periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  BIO-C (Angelus) sealer   BIO-C (Angelus) sealer will be used to obturate the root canal with 4% and 6% tapers named as subgroup A1 and subgroup A2 respectively. Post-operative pain will be checked at 6, 12, 24, 48 and 72 hours. GROUP A [CONTROL]: BIO-C (Angelus) sealer Subgroup A1: 4% Taper Subgroup A2: 6% Taper 
Intervention  BioActive RCS (SafeEndo) sealer  BioActive RCS (SafeEndo) sealer will be used to obturate the root canal with 4% and 6% tapers named as subgroup B1 and subgroup B2 respectively. Post-operative pain will be checked at 6, 12, 24, 48 and 72 hours. GROUP B [EXPERIMENTAL]: BioActive RCS (SafeEndo) sealer Subgroup B1: 4% Taper Subgroup B2: 6% Taper 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Cooperative healthy patients who are willing to participate in the study and sign consent form.
Age: 18-60 years
Teeth: single rooted teeth with asymptomatic apical periodontitis indicated for RCT.
Radiographic changes limited to slight widening of PDL space and loss of lamina dura.
 
 
ExclusionCriteria 
Details  Pregnant, medically compromised and patients with uncontrolled diabetes are excluded from the study.
Patient unable to give informed consent.
Patient taken any medication like analgesic, antibiotics, 24 hours before treatment visit 
 
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 
Post operative pain scores  Post operative pain scores at 6 hours, 12 hours, 24 hours, 48 hours and 72 hours between the group A and group B 
 
Secondary Outcome  
Outcome  TimePoints 
Post operative pain scores  Post operative pain scores at 6 hours, 12 hours, 24 hours, 48 hours & 72 hours between subgroups A1, A2, B1 & B2 
 
Target Sample Size   Total Sample Size="112"
Sample Size from India="112" 
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   N/A 
Date of First Enrollment (India)   20/05/2025 
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="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 - 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 - For individual participant data meta-analysis.

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

  6. For how long will this data be available start date provided 03-02-2026 and end date provided 03-02-2029?
    Response - Beginning 9 months and ending 36 months following article publication.

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

Postoperative pain is the most common occurrence after endodontic treatment. It occurs mainly due to mechanical, chemical or microbial injury to periapical tissues. Root canal sealers plays a crucial role in this regard by coming in contact with periapical tissues through apical foramen and lateral canals causing a localised inflammation with direct influence on degree of post-operative pain based on composition of sealers. In this regard, bioceramic sealers offer a major advantage of biocompatibility and ability to form a hermetic seal. Furthermore, bioceramic sealers enhance endodontic treatment outcomes by differentiation of odontoblasts and release of bioactive substances which aid in periapical healing. Many authors have reported apical preparations to sizes larger than recommended to completely disinfect the root canal. On the contrary, it is often argued that larger preparation size results in unnecessary removal of dentin leading to weakening of tooth structure. Recently, new injectable Bioceramic sealers have been developed possessing better properties like uniform consistency and flow which allow them to penetrate into irregularities and accessory canals of root canal system, ultimately improving the quality of obturation and endodontic outcome. No literature was found which compared the effect of root canal tapers on postoperative pain using BioActive RCS root canal sealer which is relatively new Bioceramic sealer. Hence this study is designed.

 
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