A Comparative Evaluation of Post Obturation Pain After Root Canal Treatment Using Tricalcium Silicate Versus Resin-based Sealers in Cases With Symptomatic Irreversible Pulpitis
Phase: NA
Conditions: Pain
Sponsor: Armed Forces Institute of Dentistry, Pakistan

COVERING LETTER FOR RCT REGISTRATION 
 
Submission date: 05th December, 2025 
 
To 
The Registration Officer 
ClinicalTrials.gov 
 
SUBJECT: SUBMISSION OF RCT FOR REGISTRATION 
Dear Sir/Madam, 
STUDY TITLE: “A COMPARATIVE EVALUATION OF POSTOBTURATION PAIN 
AFTER ROOT CANAL TREATMENT USING TRICALCIUM SILICATE V/S RESIN 
BASED SEALERS IN CASES WITH SYMPTOMATIC IRREVERSIBLE PULPITIS” 
This study is an interventional, two-arm randomized controlled trial evaluating postoperative pain 
management after single-visit root canal therapy. All required documents have been uploaded to 
the PRS system, and the study is ready for review. 
Please process the registration at your earliest convenience. I will provide any additional 
Information if needed. 
 
Date of submission of research proposal: 05th December, 2025 
NCT Number: "Not Issued yet” 
Unique Protocol ID: POSTOBTURATION PAIN e SEALAR 
Ethical Committee Approval Number: 918/trg 
RTMC No: DSG-2023-115-4776 
Department: Department of Operative Dentistry & Endodontics AFID, Rawalpindi, Pakistan 
 
Yours Sincerely, 
Dr. Pooja Kumari 
T.M.O Operative Dentistry & Endodontics 
AFID, Rawalpindi, Pakistan 

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A COMPARATIVE EVALUATION OF POSTOBTURATION PAIN 
AFTER ROOT CANAL TREATMENT USING TRICALCIUM SILICATE 
V/S RESIN BASED SEALERS IN CASES WITH SYMPTOMATIC 
IRREVERSIBLE PULPITIS 
 
 
DR POOJA KUMARI 
FCPS II TRAINEE OPERATIVE DENTISTRY 
ARMED FORCES INSTITUTE OF DENTISTRY 
CORRESPONDENCE:DHOMEJAPOOJA@GMAIL.COM 
 
SUPERVISOR: 
MAJ GEN NADEEM AHMAD RANA 
BDS (PB), MCPS, FCPS 
CLASSIFIED SPECIALIST IN OPERATIVE DENTISTRY 
 
DEPARTMENT OF OPERATIVE DENTISTRY 
ARMED FORCES INSTITUTE OF DENTISTRY 
 
 
 
 
 
 

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INTRODUCTION: 
 
Pain involves both physiological and psychological components, rendering pain perception subjective and 
susceptible to numerous influencing factors. The Visual Analog Scale (VAS) represents a straightforward, 
effective, and sensitive method for patients to assess pain intensity from their own perspective. (1) 
Postoperative pain following endodontic treatment often arises from an exacerbation of the inflammatory 
process in the periapical region. It is related to mechanical, chemical and microbial injury to periradicular 
tissues. The intensity of this inflammatory reaction depends on various factors, one of which includes the 
composition of the sealer used (2) 
 Root canal sealers are typically intended to remain within the root canal system, but they may come into 
contact with periapical tissues through lateral canals, the apical foramen, or by leaching. As a result, root 
canal sealers can potentially trigger an inflammatory response and cause postoperative pain. (3) 
A proper seal is essential to prevent reinfection by isolating the root tip (apex), surrounding periodontal 
space, and the entire canal. An ideal root canal sealant should be biocompatible, inert, and adhere strongly 
to the canal walls after setting. Moreover, it should offer superior sealing properties once hardened. (4) 
Aslan and Donmez Ozkan reported that both calcium silicate–based and epoxy resin–based root canal 
sealers were associated with comparable levels of postoperative pain. Shashirekha et al found that pain 
levels in the AH Plus group were higher compared to the Sealapex group, although the difference was not 
statistically significant (5) 
According to the meta-analyses performed by (Seron, M.et al) for quantitative data, the group of bio 
ceramics sealers had a lower incidence of postoperative pain compared to the control group (Resin based 
sealer) (6) 
Drummond JPSC et al. found that the mean postoperative pain at 24 hours was 0.15 (0.4) with a resin-
based sealer and 0.54 (1.3) with a bio ceramic sealer. After 7 days, the pain levels for both materials 
approached 0, with significant differences observed over time within the groups. The study concluded that 
calcium silicate-based root canal sealers cause similar, low-intensity postoperative pain compared to resin-
based sealers. (1) 
The quality of root canal filling plays a crucial role in the success rate of nonsurgical root canal treatments. 
Various types of endodontic sealers have been recommended to achieve satisfactory root fillings, with 
epoxy resin-based sealers traditionally regarded as the gold standard up to the present time.(7) 

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Biocompatibility and bioactivity are critical properties of root canal sealers, given their close proximity to 
tissues and their impact on tissue repair. However, Kim et al. reported that resin-based sealers lack 
bioactive properties and osteogenic potential compared to calcium silicate-based sealers (CSBSs).(8) 
Recently, tricalcium silicate (TCS)-based sealers have garnered attention due to their superior 
biocompatibility and bioactive properties, which promote tissue healing and regeneration (9) 
 In addition, bioceramic-based sealer demonstrated less cytotoxic and genotoxic effect in comparison with 
epoxy resin-based sealers (10) 
However, despite these advantages, the effect of TCS-based sealers on postoperative pain has not been 
thoroughly investigated. And the literature shows the contrasting results. So the rationale of this study is 
to evaluate whether a TCS (Tricalcium silicate) based sealer, specifically Bio ceramics, effectively reduces 
or eliminates postoperative pain compared to commonly used resin-based sealers. This comparison is 
crucial as postoperative pain management is a significant concern in endodontic procedures, and the 
choice of sealer could potentially impact patient outcomes and comfort. 
 
 
OBJECTIVE: 
To compare the mean & standard deviation of postobturation pain using two different sealer tricalcium 
silicate based sealer (CERASEAL) and resin based sealer (ENDOPLUS) in patients with symptomatic 
irreversible pulpitis  
OPERATIONAL DEFINITIONS:  
 Post –Operative Pain: will be defined as unpleasant sensory or emotional physical sensation, 
assessed by visual analogue scale VAS at time interval of  24hrs, 72hrs and 7 days, after obturation 
with two different sealers  
(VAS is given in ANNEX C) 
 Symptomatic Irreversible Pulpitis: A clinical diagnosis of symptomatic irreversible pulpitis is 
based on subjective and objective findings, such as severe, lingering thermal pain that may be 
spontaneous, referred, or nocturnal. This diagnosis is confirmed through patient history, clinical 
examination, and an exaggerated response to pulp vitality tests. 
 Root-canal sealer:  is radiopaque luting agent used, usually in combination with solid or 
semisolid core material, to fill voids and to seal root canals during obturation. 
 Resin based sealer: is a sealer containing epoxy-resin and is available with the name 
ENDOPLUS manufactured by PRESIDENT DENTAL Gmbh. It is available as 2 paste 
formulation (composition ANNEX –D) 

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 Tricalcium silicate based sealer: Bioceramic sealers are advanced materials used in endodontic 
procedures. Available as premixed sealer with name CERA SEAL manufactured by META 
BIOMED.CO (composition ANNEX –D) 
HYPOTHESIS:  
Null hypothesis: There is no difference in post-obturation pain using tricalcium silicate based sealer 
(bio ceramics) and resin based sealer 
Alternative hypothesis: There is a difference in post-obturation pain using tricalcium silicate based 
sealer (bio ceramics) and resin based sealer 
MATERIAL AND METHOD: 
Study design: Randomized controlled clinical trial  
Sample size calculation: A sample size of 118 (59 patients in each group) was calculated using the WHO 
calculator, with a significance level of 5% and a test power of 80%. The mean pain values on the VAS 
were extracted from a study by Drummond JPSC et al. (1). The ratio between the two groups was 
calculated at 24 hours, with an average standard deviation of 0.85.  
Mean pain score in Group 1 (resin based): 0.15 (0.4) 
Mean pain score in Group 2 (calcium silicate based):0.54 (1.3) 
Place of study: Operative dentistry and endodontics department, Armed Forces Institute of Dentistry, 
Rawalpindi. 
Duration of study: 6 months after the approval of synopsis. 
Sampling technique: Non probability consecutive sampling technique. 
 
Selection criteria: 
Inclusion criteria: 
 Patients of age group 18 to 60 years 
 Healthy patients with ASA class 1 and 2 
 Patients of both genders 
 Teeth  diagnosed as symptomatic irreversible pulpitis 
 Single as well as multirooted teeth 
 
Exclusion Criteria: 
 Teeth with calcified or previously treated canals 
 Immunocompromised or mentally handicapped patients 

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 Pregnant or lactating mothers 
 Teeth with periodontal probing depths of 5 mm or more 
 Cracked or un restorable teeth 
 Teeth where root canal instrumentation could not reach within 2 mm of the   radiographic   apex 
 
    DATA COLLECTION PROCEDURE:  
 
Study will be conducted after the approval of Institutional Ethics Review Committee of Armed Forces 
Institute of Dentistry. (Annex-A)  
Clinical trial will be registered through clinical trial.gov. An informed written consent of the patients will 
be obtained. (Annex-B) and whole procedure will be explained to the patient and attendant in simple 
language.  Demographic details (including name, age, gender, contact) will be obtained on data collection 
forms. (Annex-C). Pulpal and periodontal diagnosis will be made after history taking and thorough clinical 
examination and preoperative pain status will be recorded. Patients will be selected based on inclusion 
criteria & exclusion criteria.                 
Sample size will be randomly divided into 2 groups with the help of computer generated randomized 
patient code concealed in opaque envelope, that will be revealed just before obturation. One group will 
receive ENDOPLUS sealer and other will receive CERA SEAL bio ceramic sealer. 
Root Canal procedure will be similar for all patients ie Access Cavity preparation after administering local 
anesthesia (2% Lignocaine 1:100000 epinephrine) and rubber dam isolation. Working length will be 
determined using apex locator (Denta port ZX) and periapical radiograph with 8k and 10 k files  (dentsply 
sirona), chemo-mechanical preparation of the root canal system will be done using hybrid technique and 
copious irrigation with 2.5% NaOCL (Vista dental products) and 17% EDTA (Techno dent edetect gel)   
solution with hand files (dentsply sirona) and nickle titanium rotary file (dentsply Sirona) cleaning and 
shaping will be done up to F2 protaper (dentsply Sirona), recapitulation will be done before each 
increasing file to maintain the patency. Now canals will be dried with sterile paper point (sure endo) and 
nonsetting caoh dressing will be done, temporary filling cavit (provis) will be placed and patient will be 
recalled after one week for obturation and permanent filling.  
Obturation will be done in next visit when patient will be asymptomatic. Now patients will be randomly 
assigned to two groups based on computer generated patient’s code, one group will receive ENDOPLUS 
resin based sealer and will be obturated using single cone gutta percha point (Bio GP points-sure endo, 
sure dent cooperation) and heated plugger (system B). Other group will receive Tricalcium silicate based 
sealer(CERASEAL) and will be obturated using matched bioceramic points (FKG Dentaire SA) heated 
plugger (system B). For both the groups additional accessory cones will be used in case of wide or irregular 

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canals. Permanent restoration with composite (Coltene) will be done for both the groups and occlusion 
will be adjusted. 
Now patient will be provided VAS pain diary recalled for follow-up at 24 hours, 72 hours and 7 days.  
FOLLOW UP AND OUTCOME EVALUATION: 
Patients will be recalled after 1 week of obturation, and permanent filling and asked to record their 
response in terms of post-op pain through a self-reported questionnaire using a visual analogue scale 
(VAS). Patient will be taught how to fill this questionnaire and a pain killer medicine (ibuprofen) will be 
prescribed in case of unbearable pain and will be guided to record the dose and frequency of taken 
medicine. Two independent blinded endodontist will check the treatment radiograph for technical error or 
sealer extrusion. 
 
DATA ANALYSIS PROCEDURE:  
Data will be analysed using SPSS version 2023. Independent sample t-test will be used to compare post-
operative endodontic pain for group A and group B at 24 hours, 72 hours and 7 days after completion of 
the treatment. Descriptive statistics will be presented for both qualitative and quantitative variables. For 
quantitative variables like age, pain score Mean + S.D will be reported. For qualitative variables like 
gender frequencies and percentage will be reported. Effect modifiers like age, gender, tooth location in 
the arch and consumption of any analgesics will be controlled by stratification .post stratification 
independent t test will be applied. P value less than 0.05 will be taken as statistically significant.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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REFERENCES: 
1) Drumond JPSC, Maeda W, Nascimento WM, Campos DL, Prado MC, de-Jesus-Soares A, et al. 
Comparison of postobturation pain experience after apical extrusion of calcium silicate– and resin–based 
root canal sealers. J Endod. 2021;47(8):1278-1284. 
2) Sponchiado Junior EC, Vieira WDA, Normando AGC, Pereira JV, Ferraz CCR, Almeida JFA, et 
al. Calcium silicate-based sealers do not reduce the risk and intensity of postoperative pain after 
root canal treatment when compared with epoxy resin-based sealers: A systematic review and 
meta-analysis. Eur J Dent. 2021;15(2):347-359.  
3) Ferreira N de S, Gollo EKF, Boscato N, Arias A, da Silva E JNL. Postoperative pain after root canal filling 
with different endodontic sealers: A randomized clinical trial. Braz Oral Res. 2020;34:e0069. 
4) Memon J, Iqbal K, Mallick MR, Dehraj MA, Ali A, Kumar K. Evaluation of mean apical sealing ability of 
bio ceramic and AH Plus (Dentsply Sirona) sealer in single rooted teeth: An in vitro study. Pak J Health 
Sci. 2024;5(5):110-115. 
5) Büker M, Sümbüllü M, Ali A, Ünal O, Arslan H. The effects of calcium silicate- and calcium hydroxide–
based root canal sealers on postoperative pain: A randomized clinical trial. J Endod. 2023;49(12):1588-
1594. 
6) Seron MA, Nunes GP, Ferrisse TM, Strazzi-Sahyon HB, Victorino FR, dos Santos PH, et al. Postoperative 
pain after root canal filling with bioceramic sealers: A systematic review and meta-analysis of randomized 
clinical trials. Odontology. 2023;111(4):793-812. 
7) Kim JH, Cho SY, Choi Y, Kim DH, Shin SJ, Jung IY. Clinical efficacy of sealer-based obturation using 
calcium silicate sealers: A randomized clinical trial. J Endod. 2022;48(2):144-151. 
8) Chopra V, Davis G, Baysan A. Clinical and radiographic outcome of non-surgical endodontic treatment 
using calcium silicate-based versus resin-based sealers—A systematic review and meta-analysis of clinical 
studies. J Funct Biomater. 2022;13(2):38. 
9) Tan HSG, Lim KC, Lui JN, Lai WM, Yu VSH. Postobturation pain associated with tricalcium silicate and 
resin-based sealer techniques: A randomized clinical trial. J Endod. 2021;47(2):169-177. 
10) Coronas VS, Villa N, Nascimento AL do, Duarte PHM, da Rosa RA, Só MVR. Dentinal tubule penetration 
of a calcium silicate-based root canal sealer using a specific calcium fluorophore. Braz Dent J. 
2020;31(2):109-115. 
 
 
 
 
 
 
 
 
 

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ANNEX - A

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(ANNEX-B) 
DEPARTMENT OF OPERATIVE DENTISTRY ARMED FORCES 
INSTITUTE OF DENTISTRY RAWALPINDI 
CONSENT FORM 
I, [Patient's Name] hereby authorize DR POOJA KUMARI, department of operative 
dentistry, Armed Forces Institute of Dentistry to perform Root canal therapy using digital 
radiography and ultrasonic apex locator. 
I have been fully informed about the complete procedure and its chances of success and failure. 
I acknowledge that the information provided to me was in simple language and was fully 
understood along with being sufficient for me to consent for the procedure. I was given opportunity 
to ask questions and they were answered to my satisfaction. 
I have been fully informed about benefits of the study. 
All treatment will be performed free of cost for me. 
I am willing to undergo for the treatment. 
 
 
 
Signature of patient,                                                             Doctor’s Signature:                   
Date:      
 
 
 
 

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(ANNEX-C) 
DEPARTMENT OF OPERATIVE DENTISTRY ARMED FORCES 
INSTITUTE OF DENTISTRY RAWALPINDI 
(Data collection form) 
S.No. _________ Hospital Registration no.  ________________   Name ________     
Contact number: __________________ 
Group: ___________ 
Effect modifiers 
Age: ____           Gender: M/F _______________     Tooth no _____________         
Location in arch             ☐ Maxillary ☐ Mandibular    
Consumption of any analgesic after treatment (if any): 
☐ Name ☐ Frequency ☐ None  
 
Groups  
Pain after 24 hours 
using VAS 
Pain after 72 hours 
using VAS 
Pain after 7 days 
Using VAS 
A 
 
 
 
B
                              
VISUAL ANALOGUE SCALE (VAS)  
0    – No pain 
1-3 – Mild Pain  
4-6 – Moderate pain 
7-9 – Severe pain 
10—worst pain 
 

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(ANNEX-D) 
Composition of (ENDOPLUS) resin based sealer 
It is available as 13.5g dual syringe EndoPlus (Base 9g, catalyst 4.5g) manufactured by PRESIDENT 
DENTAL Gmbh 
Base                                           
Catalyst  
Epoxy oligomer resin  
 
Poly amino benzoate  
 
 
Ethylene glycol salicylate     
Triethanolamine  
Calcium phosphate   
 
Calcium phosphate 
Bismuth sub carbonate 
 
Bismuth sub carbonate 
Zirconium oxide 
 
 
Zirconium oxide 
 
 
 
 
 
Calcium oxide 
Composition of (BIO CERAMIC) sealer 
It is available as single paste premixed system containing  
Tricalcium silicates 
Dicalcium silicates 
Calcium aluminates 
Zirconium oxides 
Thickening agents