Evaluation of Post Operative Pain After Using Two Different Types of Sealers (a Randomized Clinical Trial )
Phase: NA
Conditions: Post Operative Pain
Sponsor: British University In Egypt

 
 
                          
  
Evaluation of Post Operative Pain after obturation 
using two different types of sealers 
(A Randomized Clinical Trial) 
 
Research proposal submitted to Department of Endodontics, Faculty of Dentistry, 
British University in Egypt, in partial fulfillment of the requirements of master’s degree in 
Endodontics 
Submitted by 
Sara Tarek Mohamed Alsayed amin 
Demonstrator in Endodontic Department Faculty of Dentistry, the British University 
in Egypt 
(B.D.S. BUE, 2018) 
 
Dr. Mohamed Medhat Kataia 
Associate Professor of Endodontics 
Acting Head of Department of Endodontics at the British University in Egypt 
Faculty of Dentistry, British University in Egypt 
 
Dr. Hala Fayek Khalil 
lecturer of Endodontics 
Faculty of Dentistry, British University in Egypt 
 
Department of Endodontics 
Faculty of Dentistry 
British University in Egypt 
2021 
Faculty of Dentistry 
The British University in Egypt 

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I. Administrative information: 
1. Title:  
     Evaluation of Post Operative Pain after obturation using two different 
types of sealers (A Randomized Clinical Trial) 
2. Protocol Registration: (For clinical trials) 
This protocol will be registered in a clinical trial website  
3. Protocol version:  
Original scientific research ( clinical trial ) 
4. Funding:  
Self-funding  
5. Roles and responsibilities: 
Sara Tarek Mohammed 
primary investigator 
Demonstrator at BUE  
 sara.alsayed@bue.edu.eg     / 01007434392 
Mohamed Medhat kataia 
 main supervisor 
Associate professor at BUE  
Mohamed.kataia@bue.edu.eg  /  01004646466 
Hala Fayek Khalil 
 co-supervisor 
Lecturer at BUE  
  Hala.fayek@bue.edu.eg  /  01287595795 
 
 
  

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Introduction 
        Pain is one of the most common complications related to endodontic 
treatment and is defined as unpleasant sensory and emotional experience 
associated with actual or potential tissue damage or described in terms of such 
damage. 
     Endodontic postoperative pain has been defined as an unpleasant 
sensation of any degree of pain that occurs after initiating root canal treatment. 
The prevalence of post operative pain after endodontic treatment is 3-58%. (1) 
      Etiology of postoperative pain is multi-factorial and depends on the 
interaction between the host response, infection, and physical injury. 
    Including determination of working length, degree of foraminal 
enlargement, number of visits, analgesics consumption, gender (2-5), technique of 
filing and instrumentation system, kinematics, trauma of periapical tissue or 
bacterial extrusion and root canal sealer. specifically, extrusion of root canal 
sealer can disrupt periodontal tissues and cause inflammatory reactions. The 
intensity of this reaction depends on the composition of the sealer. 
       Different types of sealers can be used during obturation of root canals 
like zinc oxide and eugenol sealers, resin sealers or bio ceramic sealers. Resin 
sealers maybe epoxy, or methacrylate based, they are radiopaque, have low 
solubility and are biocompatible and have good flow while bio ceramic sealers 
contain alumina, zirconia particles, bioactive glass, calcium silicates, 
hydroxyapatite, and resorbable calcium phosphates (6). These ingredients allow 
the sealers to resist bacterial leakage, rendering it biocompatible, simulating 
dynamic intratubular biomineralization. Bioceramic sealers release bioactive 
substances and   enhance endodontic treatment outcomes by facilitating the 
differentiation of odontoblasts. However, resin sealers show higher bonding 
strength and radiopacity compared to bioceramic sealers. 
     Bioceramic sealers were introduced into the market as to cause less post 
operative pain after obturation compared to other sealers that is why studies were 
conducted to validate this fact with evidence. 
 
 

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   The null hypothesis is that there is no difference in post operative pain 
between resin and bio ceramic sealers after endodontic treatment.

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Review of Literature 
Postoperative pain is defined as pain of any degree after initiation of root 
canal treatment either intra-appointment or post-obturation and is considered an 
undesirable occurrence for both patient and clinician.(7) 
After cleaning and shaping of the canals Obturation can be performed 
using different types of sealers. 
• 
Resin sealers are classified to epoxy resin based or methacrylate-
based resin sealers. Epoxy resin-based sealers are commonly used due to their 
low solubility, micro-retention to dentin of root canal and their good apical seal.  
Currently modifications of the original formula are used widely (8). Epoxy resin-
based sealers are characterized by the reactive epoxide ring and are polymerized 
by these rings. 
 
• 
Bio ceramic sealers are sealers that contain calcium silicate and/or 
calcium phosphate as their main compositions. Bioactive materials, such as 
glass and calcium phosphate, interact with the surrounding tissue to encourage 
the growth of more durable tissues (9), it can penetrate the dentinal tubules and 
interact with dentine moisture to create bonds between the dentin and core filling 
materials, an optimum dimensional stability, and the least amount of shrinkage. 
(10)  
Pain is evaluated using visual analogue scale (VAS) (11) 
• 
It is a pain rating scale. Scores are based on measures that are self-
reported of symptoms that are recorded through a single handwritten mark 
placed at one point along the length of a 10-cm line representing a continuum 
between the two ends of the scale— on the left end of the scale (0 cm) means 
“no pain “and the on the right end of the scale (10 cm) “worst pain “

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           Pak and White (12)conducted a systematic review to assess the prevalence 
and severity of pretreatment, treatment, and post-treatment pain in patients 
receiving root canal treatment. They reviewed 72 studies for meta-analysis and 
concluded that pretreatment endodontic pain of high intensity dropped 
moderately within 1 day reaching minimal levels after 7 days & post-treatment 
pain prevalence was moderate or low stating that most included articles reported 
7-day pain relief as the severity starts to drop from the first day till less than 10% 
after 7 days. 
Ali et al., (13) investigated the prevalence of post-operative pain after single 
visit endodontic treatment in the Indian population using protaper rotary files in 
addition to hand instruments by evaluating the factors that might affect pain 
experience. Their study included One thousand three hundred and twenty-eight 
patients. post-operative pain was evaluated using visual analogue scale by each 
patient by well-defined categories at three-time intervals, 12, 24, and 48 hours. 
They concluded that the prevalence of post operative pain was low  
(4%) and the important prognostic determinants of post-operative pain were 
presence of pre-operative pain, old age, gender (females recorded higher), and 
mandibular teeth but the vitality of the tooth had no effect on the intensity nor 
the frequency of post operative pain. 
Sadaf and Ahmad, (14) assessed postoperative pain and its associated 
clinical factors in endodontic therapy through a cross sectional study including 
one hundred and forty patients with premolars and molars requiring 
endododontic treatment and the treatment was performed in multiple visits. 
Results showed a significant difference in postoperative pain which was higher 
in females than males, mandibular teeth than maxillary teeth and in symptomatic 
than asymptomatic patients. There was no significant difference regarding tooth 
type, obturation length and sealer extrusion. So, gender, preoperative pain, 
maxillary, or mandibular teeth were considered risk factors affecting 
postoperative pain. 
Mathew (15) reviewed and critically analyzed the influence of various 
factors on the incidence of postoperative pain.pain was evaluated through visual 
analogue scale (VAS) and facial gramice scale . A total of thirty-eight articles 
were included in the review, the articles were classified into variables affecting 
postoperative pain after endodontic treatment. Results showed high incidence of 

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postoperative pain in females, mandibular teeth, premolars when compared to 
anteriors, with positive correlation between preoperative and postoperative 
endodontic pain. Administration of premedication’s (NSAIDs) decreases post 
operative pain. Step down instrumentation causes less debris extrusion and less 
pain. According to 13 different studies There was no significant difference 
between single or multiple visits. The effect of tooth vitality remained 
inconclusive. 
Al-Rahabi 
(16) reviewed the effects of root canal treatment on 
postoperative pain and determined the possible predictive and related factors. 
Sixty-five studies were included in the review. Results showed a strong 
relationship existed between preoperative pain and postoperative pain, as well 
as high pain prevalence among women, mandibular and molar teeth. Application 
of intracanal medications may reduce the pain between visits. Moreover, recent 
advances in endodontics regarding magnification, instrumentation technique 
and alloy metallurgy in addition to activation of irrigant to reduce microbial load 
and disinfection for higher success rates of endodontic treatment reduced 
postoperative pain in terms of both intensity and duration. On the other hand, 
age of the patient and single or multiple visit root canal treatment showed no 
statistically significant differences. 
Graunaite et al., (17) conducted a Split-mouth Randomized Controlled 
Trial to compare the effect of Resin-based and Bioceramic Root Canal Sealers 
on Postoperative Pain in sixty one patients with asymptomatic acute apical 
periodontitis (AAP) having at least 2 single rooted teeth requiring retreatment 
.Visual analogue scale was used to evaluate the pain .Obturation material was 
different for each tooth after retreatment ,they concluded that AH Plus and Total 
Fill perform similarly in terms of the occurrence and intensity of postoperative 
pain in teeth with AAP (acute apical periodontitis) with no material extrusion 
beyond the apex.  
Nabi et al., (18) conducted a randomized controlled trial to compare the 
effect of different types of sealers on postoperative pain in single visit 
endodontic treatment. Ninety patients requiring primary endodontic treatment 
were selected for the study. Patients were treated in single visit endodontically 
using three different bio ceramic-based sealers (MTA plus sealer, iroot SP, Endo 
sequence BC) dividing the sample size to three groups. Heft–Parker Pain Rating 

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Scale was used to evaluate the pain for 48 hours postoperatively. They found 
that Post endodontic pain was reduced in all treatment groups and that the three 
bio ceramic sealers can be used for single-visit endodontics without fear of 
postoperative pain. 
Fonseca et al., (19) Assessed extrusion and Postoperative Pain of a Bio 
ceramic and Resin-Based Root Canal Sealer on sixty-four patients requiring 
endodontic treatment in single rooted necrotic maxillary teeth, treatment was 
performed in a single visit and visual analogue scale (VAS) was used for pain 
assessment up to 1 week interval. Sealer extrusion was observed in 9 patients of 
the resin group and 19 patients of the bioceramic group concluding that  Bio 
ceramic sealer presented significantly more extrusion than the Resin sealer and 
that sealer extrusion was not associated with pain.  both groups had similar 
average pain level and the mean number of tablets taken for relief of pain. 
Ferriera et al., 
(20) compared the occurrence and intensity of 
postoperative pain and analgesic intake after root canal treatment, using 
different root canal sealers  on sixty single rooted necrotic asymptomatic teeth 
with apical periodontitis dividing the sample to three groups according to the 
type of sealer used for obturation(AH Plus, Endofill or MTA Fillapex) 
.Endodontic treatment was performed in two visits with placing calcium 
hydroxide dressing as intra canal medicament inter appointment . In terms of 
either incidence or intensity of postoperative pain or need for analgesic intake 
no significant differences were detected among the groups, at any timepoint. No 
pain was reported after 7 days. AH Plus, Endofill and MTA Fillapex used for 
filling root canals resulted in the same rate of postoperative pain and need for 
analgesic medication. 
Shim et al., (21) compared the effects of bio ceramic sealer and resin-based 
sealer on the incidence and intensity of postoperative pain on one hundred and 
eight patients with anteriors and premolars and molars requiring endodontic 
treatment. In groups En1(premolars or anteriors) and En2(molars), root canals 
were obturated with Endo seal MTA using the single-cone technique. In groups 
AH (premolars or anteriors) and AH2(molars), the sealer used was AH Plus with 
the continuous wave technique. Pain was assessed through visual analogue scale 
over 7 days period. They found that: Endo seal MTA and AH Plus had similar 

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effects on the incidence and intensity of postoperative pain. The obturation time 
was shorter when using Endo seal MTA compared to AH Plus. 
 
 
PICO 
P: patients diagnosed with irreversible pulpitis age from 18-50 years old 
I: obturation with bioceramic sealer  
C: obturation with resin sealer  
O: effect on post operative pain  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Aim of the study 
 
The aim of this randomized clinical trial is to evaluate the post-operative   
pain after obturation using Resin Vs. Bioceramic sealers. 
 

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Participants and Methods 
I-Materials  
Round bur/endo Z/tapered round stone 
Rubber dam 
#10 k files 
Apex locator 
#15 #20 k files 
Side vented needle  
5.25% sodium hypochlorite 
Rotary files  
Endo motor 
Sensor 
Paper points  
Gutta percha points  
Resin sealer 
Bioceramic sealer 
Torch  
Condenser  
Cotton and temporary filling  
 
 
 
 
 
 
 

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II-participants  
A-Sample size determination: 
Sample size calculation was performed using G power (3.1.9.4) software, 
based on a previous study (22) using an alpha (α) level of 0.05 and beta (β) level 
of 0.85 The predicted sample size (n) is a total of 40. 
B-Patient’s selection: 
1-Eligibility criteria: 
Inclusion criteria: 
• 
Patients age ranges from 18-50 years old.  
• 
Patients with teeth diagnosed with symptomatic irreversible pulpitis.  
• 
Normal periapical condition confirmed by normal periapical 
radiograph or that with minimal widening of the PDL space 
• 
The teeth are restorable  
• 
 Teeth are periodontally free. 
 
Exclusion criteria: 
• 
Teeth with immature roots  
• 
Non restorable teeth  
• 
Medically compromised patients with systemic complication that 
would alter the treatment.  
• 
Necrotic teeth 
• 
Teeth with apical periodontitis or periapical lesions  
• 
Teeth that need multiple visits treatment 
 
 
 
 
 
 

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2-Ethical consideration: 
Patient will be asked to follow general instructions and to sign a printed 
informed consent explaining the aim of study, brief of study methodology, 
benefits and complications of the procedure and requesting that they allow 
clinician to follow up after performing the treatment. This study will be 
performed in compliance with the ethical standards laid down in the 2013 
Declaration of Helsinki  
Adverse events during the trial will be reported to supervisor and co 
supervisor and monitors of ethical committee 
 
C-Patient allocation: 
Using computer generated randomization, the participants will be allocated 
randomly into two equal groups. 
The sequentially numbers that will be generated, will be placed in opaque 
envelope until the intervention and each participant will be asked to select an 
envelope that determine which group of intervention he will be assigned.  
 
D-Patient Classification: 
Patients were randomly divided into two groups according to material 
used for obturation .  each patients name will be replaced with a case number 
within the group to protect the privacy of medical information and data of the 
patients  
Group (1) resin sealers  
Group (2) bio ceramic sealer  
 
 
 
 
 

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Methods  
Procedural steps: 
• 
Pain scale chart will be given to each patient to rate his /her pain level 
before endodontic treatment as preoperative reading on a visual analogue scale 
(VAS)  
• 
Tooth will be anaesthetized using Local anesthesia containing 
Articaine with epinephrine 1:100,000.  
• 
Access cavity will be performed using a carbide round steel bur and 
tapered diamond stone until complete deroofing.  
• 
Rubber dam isolation of tooth  
• 
Patency is gained and working length is recorded using apex locator 
and confirmatory radiograph. 
• 
Cleaning and shaping using rotary system 
• 
Irrigation using 5.25% sodium hypochlorite introduced using side 
vented needle 
• 
Activation of the irrigant  
• 
Master cone check 
• 
obturation 
• 
temporary restoration will be placed  
 
 
 
 
 
 
 
 

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Methods of evaluation 
Post operative pain  
Each patient will be asked to fill the visual analogue scale (figure 1) to 
rate the pain level postoperatively at 6, 24, 48, and 72 hours following the end 
of the procedure. 
      
 
Figure 1: Visual analogue scale used by the patient to report pain level at different time intervals 
 
G-Statistical analysis: 
Data obtained will be tabulated in the form of groups and case numbers 
to protect patient’s confidentiality. 
Data will be statistically analyzed using non-parametric tests  to 
compare numerical variables (age, VAS scores) amongst the groups. other test 
will be used to evaluate the changes in pain scores over time. Categorical 
variables (gender, type of teeth) will be  compared amongst the groups . Also, 
the correlation assessments between age factor and postoperative pain, and 
gender factor and postoperative pain will be done. 
 

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