Comparative Evaluation of Postoperative Pain After Using Endoactivator, Side Vented and Open Ended Endodontic Needles as Final Irrigation Protocols During Root Canal Treatment
Phase: NA
Conditions: Post Operative Pain
Sponsor: Armed Forces Institute of Dentistry, Pakistan

Official Title: Comparative evaluation of postoperative pain 
after using Endoactivator, side vented and open-ended 
endodontic needles as final irrigation protocols during root 
canal treatment 
NCT Number: NCT05840783 
Date: 04-02-2024 
 
 

Study Protocol  
A detailed dental and medical history was taken for each patient before the 
commencement of treatment. A preoperative data chart for each patient was recorded 
that included tooth number, age, sex, and pain intensity before the treatment. The 
Visual Analog Scale (VAS) was used to measure the intensity of pain. The pain intensity 
was measured verbally and in standard numerical values with VAS, in the range of 0–10 
as; 
0 
No pain 
1-3 
Mild pain 
4-6 
Moderate pain 
7-10 
Severe pain 
 
All the eligible participants were guided about the study design and treatment protocol in 
detail and informed written consent was obtained from the patients. Although the 
patients were briefed about the study protocols and the type of irrigation devices used, 
they were not told about the device used particularly in their case. 
Treatment Protocol  
To ensure uniformity in outcome, procedures on all the patients were performed by a 
single practitioner who was a second-year postgraduate resident at the Department of 
Operative Dentistry and Endodontics, with two years of clinical experience. 
Endodontic Protocol 
The endodontic treatment for all the patients began with the application of topical 
anesthetic gel, followed by local anesthesia with 1.8 ml of 2% lignocaine with 1:200,000 
epinephrine. The effectiveness of anesthesia was ensured by a negative response to 
cold and electric pulp tests. Afterward, rubber dam isolation was strictly followed in all 
the cases to ensure an aseptic environment, and a dental operating microscope (Zeiss 
– OPMI PICO, Germany) was used for access cavity preparation using sterile diamond-

coated burs. After access cavity modification, the initial glide path was obtained and 
maintained using manual stainless steel endodontic instruments (hand files).  
For working length determination, size #10 hand K-files (Mani, Tochigi, Japan) were 
used with copious irrigation (2.5% NaOcl) and lubrication (EDTA). The working length 
was estimated with an electronic apex locator (Root ZX II - J.Morita, Tokyo, Japan), and 
confirmed with 2 periapical radiographs at different angles for accuracy. The root canals 
were then prepared with Hyflex EDM rotary files (Coltene, Switzerland) within 0.5 mm of 
the estimated working length following the manufacturer’s guidelines up to 25/VT size. 
An electric endomotor (X-Smart; Dentsply Maillefer, Switzerland) with a reduction gear 
handpiece (16:1) was used for rotary preparation with recommended speed (500 rpm), 
torque (2.5 Ncm), and motion (clockwise rotation) settings. To maintain the glide path, 
and apical patency and prevent the extrusion of debris beyond the apex, recapitulation 
was done continuously during the procedure using #10 K-file.  
Irrigation Protocol  
The irrigation protocol was different for each group and was performed using the 
designated devices for the patients of each particular group. 
 For group A (Open ended needle): 5 mL of 2.5% NaOCl (Septodont, USA) was 
introduced into each canal with a 30-gauge notched tip needle (Septodont, USA) 
3mm short of the working length, without any vertical strokes and wedging the 
needle inside canals. 
 For group B (Side vented needle): 5 mL of 2.5% NaOCl (Septodont, USA) was 
introduced into each canal via a 30-gauge side-vented Trunatomy needle 
(DENTSPLY, USA), carefully placed 1 mm short of the working length. 
 For group C (Endoactivator): 3 mL of 2.5% NaOCl (Septodont, USA) was 
introduced into the pulp chamber using a 30-gauge notched tip needle 
(Septodont, USA). The Endoactivator with a tip size #15/0.02 was then carefully 
positioned 2 mm short of the working length and activated at a frequency of 
10,000 cycles/minute with 2mm vertical strokes inside each canal for 2 minutes. 

The patients were briefed about the different irrigation protocols but not the one used 
particularly in their case, to ensure blinding. During the irrigation process, the patients 
were not shown the devices used. After irrigation, the canals were dried with sterile 
absorbent paper points and restored with intermediate restorative material (Cavit – 3M, 
USA) without any intracanal dressing. 
Outcome Measure  
After the procedure, all the participants received a VAS data sheet with all the 
necessary information. The patients were also advised not to take any medication 
without the operator’s advice and should call the operator in case of pain, for proper 
prescription and documentation. In case any patient complained of pain, a dose of 200 
mg Ibuprofen was prescribed as an escape medication. 
Patients were called at 8, 24, and 48 h intervals after the treatment via telephone to 
note their responses and feedback. The pain intensity was recorded using both the 
numeric and verbal (VAS) pain scales, and the quantity of ibuprofen pills consumed by 
the patient at each follow-up interval. All the collected data was then carefully recorded 
on the patient’s chart. 
Statistical Analysis 
All the data was presented and organized in Microsoft Excel. SPSS version 23.0 for 
Windows was used for the descriptive analysis, and calculation of mean and standard 
deviation. The Kruskal-Wallis test was used for the comparison between the three 
groups at each time interval, and the Mann-Whitney U test was then used as post-hoc 
test. At all different time intervals (8, 24, and 48 hours) the change in VAS score in each 
group was analyzed and compared using the Kruskal Wallis test and Mann-Whitney U 
test. It was considered statistically significant if the value of P<0.05. 
Results 
No significant difference in age distribution (p=0.742) evaluated by Kruskal-Wallis and 
gender (p=0.963) evaluated by Pearson Chi-square was observed across all three 
groups.  

Variables (mean ±SD) 
GROUP-A 
GROUP-B 
GROUP-C 
p-value 
Age (years) 
38.91±13.42 
38.34±10.23 36.8±12.35 
0.742* 
Gender 
Male n (%) 
18 (51%) 
19 (54%) 
18 (51%) 
0.963** 
Female n 
(%) 
17 (49%) 
16 (46%) 
17 (49%) 
Table 1 Demographics of the Population Data 
*Kruskal Wallis test; **Pearson Chi-square test 
 
 
Pre-operative pain ranged from 4-10 among the participants with an average pain score 
of 6.34 in GROUP-A, 6.34 in GROUP-B, and 6.11 in GROUP-C. Mann-Whitney test and 
Kruskal Wallis (p>0.05) test showed no difference in pain distribution across the groups.  
The pain scores at 8 hrs post operation ranged from 0-10 with the lowest mean score of 
3.31 in group GROUP-C followed by 4.02 in group GROUP-B and 5.77 in group 
GROUP-A. Pain scores at 24 hr post operation ranged from 0-7 with the lowest mean 
score of 2.31 in group GROUP-C followed by 2.66 in group GROUP-B and 3.74 in 
group GROUP-A. Pain scores at 24 hr post operation ranged from 0-6 with the lowest 
mean score of 1.28 in group GROUP-C followed by 1.65 in group GROUP-B and 2.94 
in group GROUP-A. A significant difference between the three groups (GROUP-A, 
GROUP-B, and GROUP-C) was observed at all times (at 8 hr, 24 hr, and 48 hr) post 
operation with p values less than 0.05.  
Mann-Whitney test conducted to assess a significant difference in the pain distribution 
across the groups revealed a significant difference observed in pain experience at the 
8-hour time interval between GROUP-A and GROUP-B with p=0.005 and a highly 
significant difference between GROUP-A and GROUP-C with p=0.000 was observed. A 
significant difference between GROUP-A and GROUP-C with p=0.001 and between 
GROUP-A and GROUP-B with p=0.018 at 24 hr time interval and between GROUP-A 
and GROUP-C and between GROUP-A and GROUP-B with p=0.000 at 48 hr time 
interval. No significant difference was observed in the intensity of pain experienced 
between the Endoactivator and side-vented needle irrigation groups.  

The data represented in Table /Fig 4 shows the comparison between the three groups 
with respect to NSAIDS taken by patients as a relief from post-operative pain revealing 
a significant difference (p<0.05) by Kruskal Wallis test between the groups under study 
at 8 hours, 8-24 hours and 24-48 hours. Mann-Whitney test found a significant 
difference in NSAIDS intake between GROUP-A and GROUP-C (p=0.005) and between 
GROUP-B and GROUP-C (P=0.007) at 8-hour time intervals. No significant difference 
(p=0.852) was observed between GROUP-A and GROUP-B when NSAIDs intake was 
evaluated at this time interval. During 8-24 hours a high significant difference between 
GROUP-A and GROUP-B with p=0.003 and between GROUP-A and GROUP-C with 
p=0.000 was observed. In contrast, no significant difference (p=0.270) was observed 
between GROUP-B and GROUP-C. A highly significant difference at 24-48 hr time 
interval was observed between GROUP-A and GROUP-B and between GROUP-B and 
GROUP-C (p=0.000) and also between GROUP-B and GROUP-C (p=0.033).  
 
Pain 
 
Group 
 
N 
 
MGroup
-An (SD) 
 
Rang
e 
 
Media
n (Q1-
1 
Q3) 
Kruskal 
Wallis test 
Mann-Whitney U test (p-
value) 
Chi-
squar
e 
value 
p-
valu
e 
GROUP
-A vs 
GROUP
-B 
GROUP
-A vs 
GROUP
-C 
GR
OU
P-B 
vs 
GR
OU
P-C 
Preoperative 
GROUP-
A 
3
5 
6.34 
(1.30) 
4-10 
6 
 
 
0.902 
 
 
0.54
2 
(NS) 
0.821 
0.361 
0.6
79 
(NS
) 
GROUP-
B 
3
5 
6.34 
(1.89) 
4-10 
6 
GROUP-
C 
3
5 
6.11 
(1.62) 
2-10 
6 
8 hours 
GROUP-
A 
3
5 
5.77 
(2.15) 
2-10 
5 
18.86 
0.00
0 
0.005 
0.000 
0.3
19 
(NS
) 
GROUP-
B 
3
5 
4.02 
(2.47) 
1-8 
4 
GROUP-
C 
3
5 
3.31 
(1.76) 
1-6 
3 
24 hours 
GROUP-
A 
3
5 
3.74 
(1.89) 
1-6 
4 
11.66
8 
0.00
3 
0.018 
0.001 
0.2
03 
(NS
) 
GROUP-
B 
3
5 
2.65 
(1.47) 
0-6 
2 
GROUP-
C 
3
5 
2.31 
(1.51) 
1-6 
2 

48 hours 
GROUP-
A 
3
5 
2.94 
(1.49) 
1-6 
3 
25.54
3 
0.00
0 
0.000 
0.000 
0.1
01 
(NS
) 
GROUP-
B 
3
5 
1.65 
(0.90) 
0-3 
2 
GROUP-
C 
3
5 
1.28 
(0.78) 
0-3 
1 
 
 
Pain 
 
Group 
 
N 
 
MGroup-
An (SD) 
 
Range 
 
Median 
(Q1-1 
Q3) 
Kruskal 
Wallis test 
Mann-Whitney U test (p-value) 
Chi-
square 
value 
p-
value 
GROUP-
A vs 
GROUP-
B 
GROUP-
A vs 
GROUP-
C 
GROUP-
B vs 
GROUP-
C 
8 
hours 
GROUP-
A 
35 1.34 
(0.76) 
0-2 
2 
10.23 
0.006 0.852 
(NS) 
0.005 
0.007 
GROUP-
B 
35 1.31 
(0.76) 
0-2 
1 
GROUP-
C 
35 0.82 
(0.71) 
0-2 
1 
8-24 
hours 
GROUP-
A 
35 1.06 
(0.72) 
0-2 
1 
16.180 
0.000 0.003 
0.000 
0.270 
(NS) 
GROUP-
B 
35 0.56 
(0.49) 
0-1 
1 
GROUP-
C 
35 0.43 
(0.47) 
0-1 
0 
24-
48 
hours 
GROUP-
A 
35 0.91 
(0.61) 
0-2 
1 
38.416 
0.000 0.000 
0.000 
0.033 
GROUP-
B 
35 0.28 
(0.46) 
0-1 
0 
GROUP-
C 
35 0.08 
(0.28) 
0-1 
0 
 
 
 

Informed Consent Form 
DEPARTMENT OF OPERATIVE DENTISTRY 
ARMED FORCES INSTITUTE OF DENTISTRY 
RAWALPINDI 
I                            hereby authorize, Dr. Ahmed Abdullah, Department of Operative 
Dentistry, Armed Forces Institute of Dentistry to perform treatment using digital 
radiography and an electronic 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 to the procedure. I was given 
the opportunity to ask questions that were answered satisfactorily. 
I have been fully informed about the benefits of the study. 
All treatment will be provided free of cost to me. 
I am willing to undergo treatment.  
Signature of Patient: _________________ Signature of Doctor: ________________ 
Date: __________