Comparative Evaluation of Post-operative Pain With Different Apical Finishing Sizes After Single Visit Root Canal Treatment
Conditions: Pain Assessment
Sponsor: British University In Egypt

Cover page 
Authors Mohamed Medhat Kataia, Muhammed ahmed omar abouel seoud, 
Hala Fayek Khalil, Engy medhat Kataia 
Research title: Comparative Evaluation ofPost-operative pain with different 
apical finishing sizes after single visit root canal treatment 
Research approved by Research ethics committee the British university in 
Egypt  
Research Approval Number: 7/3 /2023 
Number 23-002 

Comparative Evaluation of Post-operative pain with different 
apical finishing sizes after single visit root canal treatment
 
Introduction:
Apical preparation size is a very important variable in the 
process of root canal preparation. There have been many conflicts 
regarding the proper size and how it affects bacterial reduction, 
root canal dentine strength in terms of conservation and even post-
operative pain. Post-operative pain as a patient related outcome, 
with different apical sizes is very important. In this study, we will 
evaluate the postoperative pain after root canal enlargement with 
two sizes after the binding file compared to three sizes after the 
binding file without disregard of mechanical principles of root 
canal preparation.
Materials
E3 Azure Poldent files
Resin sealer
k-files Mani
Subjects:
This is a proposed randomized controlled parallel clinical, 
prospective split mouth, triple blinded study. Sample size 
calculation was conducted using G*Power 3.1.9.4 software based 
on data obtained from a previous study.[hala’s paper which 
compared the effect of different kinematics on post operative 
pain(patients) ] It was estimated that a minimum sample size of 19 
subjects (sides) per group for a total of 38 sides would be essential 
for an effect size of 0.97 with an alpha error of 0.05 and a power 
beta of 0.90 to achieve 95% confidence of a true difference 
between the groups. Sample size was increased by 25% to 25 
subjects per group for a total of 50 sides to compensate for drop-
outs.
Inclusion criteria:
Of the 25 patients all must have the following:
Age: 20-50

Gender: Males and Females, random selection.
Systemic status: healthy patients (Category: American Society of 
Anaesthesiologists class 1)
Bilateral exposed mandibular first or second permanent molars
Molars should have separate mesial and distal roots
Mesial roots confirmed to be type three root canal system
Distal root confirmed to be type one root canal system
Normal periapical radiograph and no bone changes
Symptomatic irreversible pulpitis
I.B.F. in mesial roots not more than #20, and distal root not more 
than #30
Exclusion criteria:
Type two root canal system in mesial roots
Type two or three root canal systems in distal roots
Signs of apical involvement in the radiograph
Any systemic conditions altering the treatment or requiring 
medications or precautions
 
Patient selection and preparation:
All root canal treatments were performed by a single endodontic 
consultant. All subjects were selected from walk in patients 
presented to the endodontic clinic of the British university in 
Egypt. Cases that were diagnosed and did not meet the inclusion 
criteria were referred to the intern clinic for dental care. Cases that 
met the inclusion criteria where selected for this study. All patients 
were verbally informed about the procedure’s benefits and that the 
results of the treatment will be used to this study and the risks of 
the procedure was explicitly explained to them. After the verbal 
consent patients were handed a written form consent to sign upon.
 
Procedure:
Radiographs were taken by a Paralleled long cone periapical 
radiography. To ensure a visible root canal ≤30° of canal curvature 
and a periapical index (PAI score) of 3–5 according to Orstavik et 

al., (1986) in addition of initial confirmation of root canal types. 
All patients were anesthetized, rubber dam applied, and access 
cavities were performed. After root canal exploration and 
scouting, root canal systems were reconfirmed to be the types 
selected for this study.
Initial binding file was selected for all root canals to ensure it met 
the inclusion size of mesial roots #20 and distal #30. After patency 
and glide path were performed by K-files up to size #20, engine 
driven canal enlargement was applied using E3 Azure files to final 
finishing size according to the grouping.
Group A: (left side of the patient) will be prepared 2 sizes 
larger than the IBF, to size 35#/.04 mesial canals and 40#/.04 
distal canals.
Group B: (right side of the patient) will be prepared 3 sizes 
larger than the IBF, to size 40#/.04 mesial canals and 45#/.04 
distal canals.
All data of post-operative pain will be recorded by a second 
blinded clinician through a visual analog scale (VAS). Post-
operative monitoring periods will be recorded in 12 hours, 24 
hours, 3 days and 1 week.
Data will be sent to the statistician with group names only to 
fulfill the triple blinding criteria and results will be interpreted