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CTRI Number  CTRI/2023/07/055672 [Registered on: 25/07/2023] Trial Registered Prospectively
Last Modified On: 23/07/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To Compare post operative pain after single sitting root canal treatment using two different material:A randomized controlled Trial 
Scientific Title of Study   Comparative evaluation of the Effects of a BioCeramic and Epoxy Resin-Based Sealer on Postoperative Pain and healing outcomes after single visit Root Canal Treatment in non-vital teeth: 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 Ashish P Mandwe 
Designation  ASSOCIATE PROFESSOR 
Affiliation   
Address  301,Department of conservative Dentistry and endodontics Nair hospital dental college,Dr Al nair road mumbai central 08
Sec 3 Kharghar plot no e 22 23 24 402, parth recidency
Mumbai (Suburban)
MAHARASHTRA
400008
India 
Phone  09220524842  
Fax    
Email  drmandwe@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ashish P Mandwe 
Designation  ASSOCIATE PROFESSOR 
Affiliation   
Address  301,Department of conservative Dentistry and endodontics Nair hospital dental college,Dr Al nair road mumbai central 08
Sec 3 Kharghar plot no e 22 23 24 402, parth recidency
Mumbai (Suburban)
MAHARASHTRA
400008
India 
Phone  09220524842  
Fax    
Email  drmandwe@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ashish P Mandwe 
Designation  ASSOCIATE PROFESSOR 
Affiliation   
Address  301,Department of conservative Dentistry and endodontics Nair hospital dental college,Dr Al nair road mumbai central 08
Sec 3 Kharghar plot no e 22 23 24 402, parth recidency
Mumbai (Suburban)
MAHARASHTRA
400008
India 
Phone  09220524842  
Fax    
Email  drmandwe@gmail.com  
 
Source of Monetary or Material Support  
301,Department of conservative Dentistry and endodontics Nair hospital dental college,Dr Al nair road mumbai central 08 
 
Primary Sponsor  
Name  Ashish Mandwe 
Address  nhdc mumbai 
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 Ashish Mandwe  NAIR HOSPITAL DENTAL COLLEGE  301,Department of conservative Dentistry and endodontics Nair hospital dental college,Dr Al nair road mumbai central 08 DR A L NAIR ROAD MUMBAI CENTRAL
Mumbai
MAHARASHTRA 
9220524842

drmandwe@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Nair Hospital Dental College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy patients 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  AH Plus Sealer Group  Following complete cleaning and shaping, canals will be dried using paper points. Obturation will be completed using lateral condensation technique will be used along with AH plus sealer (DENTSPLY Maillefer – USA)using Lentulospiral method of sealer placement technique.The tooth will be sealed by Zinc oxide temporary restoration(Cavit) and postoperative pain will be assessed immediately after the end of treatment. A research assistant who was not involved in the treatment will taught the patients to fill in the pain diary. 
Intervention  BioCeramic Sealer Group  Following complete cleaning and shaping, canals will be dried using paper points. Obturation will be completed using lateral condensation technique will be used along with BioCeramic Sealer in one group (Meta CeraSeal) which is calcium silicate based sealer.The tooth will be sealed by Zinc oxide temporary restoration(Cavit) and postoperative pain will be assessed immediately after the end of treatment. A research assistant who was not involved in the treatment will taught the patients to fill in the pain diary. 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Healthy adults (Male and female) aged between 21- 45 years
History of taking analgesic, not with in 72 hrs.
Permanent mandibular first molars with fully formed apex undergoing endodontic
treatment with infected root canals or having radiographic evidence of apical
periodontitis in nonvital teeth
Straight to curved canal with Canal curvature up to 20 degree(Schneider method)
Permanent mandibular first molars with necrotic pulp with/without periapical lesion
as per OstrovikPAI score 1,2,3.30
Main inclusion criteria were pulpal necrosis confirmed by negative response to hot
and cold test with/without periapical lesion as per OstrovikPAI score 1,2,3.30
Presence of enough coronal tooth structure for rubber dam isolation. 
 
ExclusionCriteria 
Details  Teeth with previous root canal treatment and restorations.
Teeth with cracks or fractures
Patient taking analgesic with in 72 hours of period.
Unrestorable teeth
Teeth with incomplete root formation
Calcified canals
Internal resorption in canal
or normal pulpof patient being referred for intentional endodontic therapy for
prosthetic reasons to undergo a single visit root canal treatment.
Teeth indicated for retreatment  
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess and compare incidence of post-obturation pain following single sitting root
Canal Treatment using Bioceramic and Epoxy resin-based sealer in nonvital teeth. 
To assess and compare incidence of post-obturation pain following single sitting root
Canal Treatment using Bioceramic and Epoxy resin-based sealer in nonvital teeth. 
 
Secondary Outcome  
Outcome  TimePoints 
Follow up for 2 years to check healing outcome on basis of clinical and radiographic   2 years 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   03/08/2023 
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="2"
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 - All of the individual participant data collected during the trial, after de-identification.

  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 who provide a methodologically sound proposal.

  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 [drmandwe@gmail.com].

  6. For how long will this data be available start date provided 21-12-2025 and end date provided 21-12-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NA
Brief Summary  
The incidence of postoperative pain after non-surgical root canal treatment is reported to be
in the range of 0 to 48%1,2. Several factors affecting postoperative pain have been
investigated, including working length determination,apical patency, various
Instrumentation or irrigation protocols, number of visits intracanal medicaments root canal filling techniques   and occlusion reduction 
There were no differences in postoperative sensitivity in studies compared post-obturation pain using the same root canal
filling techniques but with different sealers in a single visit endodontic treatment.
Tricalcium silicate-based hydraulic cements are gaining popularity in non-surgical root
canal treatment. Even though long-term clinical trials are lacking, silicate-based hydraulic
cements have shown to be less cytotoxic compared to resin-based sealer in both ex vivo and
animal models.Premixed calcium silicate-based sealer has excellent physicochemical and
biological properties, both with in vitro and in vivo animal studies, compared with
conventional sealers .Root canal filling with calcium silicate-based sealer and a single
gutta percha cone using a sealer-based filling technique (SBT) is now widely accepted,
with a 90.9%reported success rate in a retrospective clinical study at three years of observation 
.Graunaite et al. (2018) found no statistically significant difference in postoperative pain
when previously treated teeth were obturated with the different sealers using a warm
vertical compaction technique. The postoperative pain was generally mild and did not last
past 72 hours.11 Another trial by Ates et al. (2019) measuring postoperative pain after
obturation using a carrier-based system with either AH plus R or iRoot SPR also showed
that postoperative pain levels were not affected by the type of sealer used, although patients
who received iRoot SPR required less analgesics postoperatively.
Christine Men Martins et al (2019) meta-analysed and found that Rotary instrumentation
generated more events of pain confirming the hypothesis that rotary motion causes more
postoperative pain after endodontic treatment. In addition, more patients presented with
severe pain after 48 h under rotary motion compared to reciprocating motion. Therefore,
Additional randomized clinical studies are required on this subject. 
A large number of studies investigated the effect of various instrumentation systems on
postoperative pain. According to a recent meta-analysis by Sun et al.33 and
CaviedesBucheli et al.34, the use of multiple-file rotary systems showed a lower incidence
of postoperative pain than the single-file reciprocating systems. On the contrary,
Neelakantan& Sharma 13 and Shokraneh27 reported higher pain intensity with multiple-file
rotary systems when compared to single-file reciprocating systems But literature lacking
,with the introduction newer generations single rotary file like One shape, and its impact
on post operative pain.Also, literature search, shows few clinical studies compared effect of different sealer on
post obturation pain using Bio ceramic sealer and conventional resin-based sealer using
single sitting root canal treatmentafter using use of single file rotary system in non-vital
teeth.Furthermore, most of cases analysed on meta-analysis by Christine Men Martinset al
(2019) were on vital pulp teeth, which were considered to have less extrusion of
microorganisms into the periapex since root canal was not massively infected. It is reported
in the literature that an asymptomatic necrotic pulp with a periapical lesion is the most
likely predisposing clinical condition for the occurrence of postoperative pain.15It is also
observed that nonvital pulp teeth presented with more pain at 6 h and continued till 48 h
irrespective of file system and motion used.
So, in this in vivo study we will compare BioCeramic sealer and AH Plus sealer on post-
obturation pain in non- vital asymptomatic and symptomatic teeth which have undergone

root canal treatment at 6-, 12,24-,48- and 72-hour interval short term follow up and 7 to 10
days midterm follow-up.
There is need to verify weather after using newer bio ceramic sealers, will there be any

difference in post operative pain incidence and healing outcomes in non-vital teeth.

Primary objective is to assess incidences of post-obturation pain following single sitting
root canal treatment using BioCeramic sealer and resin-based sealer in nonvital teeth. And subsequent follow up for 2years to check healing outcomes using clinical and
radiographic interpretation.
 
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