CONSORT Randomized Clinical Trial
The Effect of Foraminal Enlargement of Necrotic
Teeth with a Continuous Rotary System on
Postoperative Pain: A Randomized
Controlled Trial
Ibrahim Ethem Yaylali, PhD,* Anil Teke, PhD,† and Yasar Meric Tunca, PhD‡
Abstract
Introduction: This single-blind, randomized controlled
trial aimed to evaluate whether foraminal enlargement
(FE) with a continuous rotary system during endodontic
treatment causes more postoperative pain than nonfor-
aminal enlargement (NFE). Methods: Seventy qualified
patients were randomized into 1 of 2 groups in a 1:1 ra-
tio using a series of random numbers: the FE group and
the NFE group. The patients were followed up for 7 days
to evaluate between-group differences in the outcome
measures. The study participants were selected from
among patients who had necrosis and apical periodon-
titis in the maxillary or mandibular molar teeth. The pri-
mary outcome was to assess postoperative pain
severity, and the secondary outcome was to evaluate
analgesic consumption during the follow-up period.
Pain severity was evaluated for the first 7 days using a
visual analog scale (VAS). The VAS consisted of a
100-mm line. Pain severity was assessed as no pain
(0–4 mm), mild pain (5–44 mm), moderate pain (45–
74 mm), and severe pain (75–100 mm). The quality of
life of patients during the follow-up period was assessed
using a quality of life scale. The Student t test was used
to identify statistically significant differences between
the study groups (P < .05). Results: A significant differ-
ence was noted in postoperative pain in the first 2 days;
the FE group experienced more pain than the conven-
tional NFE group (P < .05). In the FE group, 12 and 11
patients (34% and 31%) had severe postoperative
pain (VAS score, >74 mm) on the first day and second
day, respectively. VAS pain scores between the groups
were not different (P > .05) on other days. No significant
difference was found in analgesic consumption between
the groups (P > .05). Conclusions: On the basis of the
VAS results, this randomized controlled trial indicates
that FE causes more pain on the first 2 days after an end-
odontic treatment. (J Endod 2017;43:359–363)
From the *Department of Dentistry, Isparta Military Hospital, Isparta, Turkey; †Department of Dentistry, Egirdir State Hospital, Isparta, Turkey; and ‡Department of
Endodontics, Near East University, Mersin, Turkey.
Address requests for reprints to Dr Ibrahim Ethem Yaylali, Department of Dentistry, Military Hospital, 1st Floor, Isparta, Turkey. E-mail address: ibotenring@yahoo.
com
0099-2399/$ - see front matter
Copyright ª 2016 American Association of Endodontists.
http://dx.doi.org/10.1016/j.joen.2016.11.009
JOE — Volume 43, Number 3, March 2017
Key words
Endodontics, foraminal enlargement, postoperative pain, rotary systems
P ulp necrosis and apical
periodontitis are con-
ditions that affect periapi-
Significance
This randomized controlled trial indicated that
foraminal enlargement with a continuous rotary
cal tissues and the entire
system caused more postoperative pain in the first
root canal system (1, 2).
2 days. Although foraminal enlargement caused
Molecular analyses have
severe pain in 30% of patients, none of these pa-
indicated the presence of
tients needed an additional and unscheduled visit.
bacterial biofilms not
only within the apical
part of the root canal system but also within the apical lesion itself (3–5).
Furthermore, some studies have shown that bacteria can form a biofilm by extending
the extraradicular area from the root canal through the apical foramen and then
adhere to the cementum over the root apex (4, 6). Thus, it seems acceptable to
enlarge the apical foramen for the healing of apical periodontitis (7).
Foraminal enlargement (FE) refers to intentional and mechanical enlargement of
the apical foramen to reduce the bacterial load by excising the infected cementum and
dentin (7). In an animal study, Borlina et al (7) showed that such enlargement of the
apical foramen could decrease the microbial load and facilitate the healing of chronic
periapical lesions. In another animal study, de Souza-Filho et al (8) indicated periapical
tissue repair in pulp necrosis cases in which the apical foramina was enlarged during
shaping. Therefore, intentional enlargement of the apical foramen may be necessary
from a microbiological viewpoint for reducing microbial load when endodontic infec-
tion extends beyond the limits of apical constriction and for repairing periapical
tissues (7, 8).
Some concerns have been raised over the apical limit of root canal instrumentation
during cleaning and shaping. Siqueira (9) reported that FE may cause a higher inci-
dence of pain because of mechanical irritation of periapical tissues. Furthermore,
debris extrusion may lead to periapical inflammation, which ranges between 1.4%
and 16% (9), and pain, which ranges between 3% and 58% (10). One study indicated
that the disruption of apical constriction may cause considerable apical debris extru-
sion (11). Therefore, there exists uncertainty regarding postoperative pain caused
by the disruption of apical constriction during the enlargement of the apical foramen.
Foraminal Enlargement and Postoperative Pain 359
CONSORT Randomized Clinical Trial
Several randomized controlled trials (RCTs) have evaluated the ef-
fect of FE on postoperative pain. Silva et al (12) assessed postoperative
pain after enlarging the apical foramen created with hand files; they
concluded that both FE and nonforaminal enlargement (NFE) caused
the same level of postoperative pain. Cruz Junior et al (13) reported
that FE using a reciprocating system caused more pain than NFE at
24 hours. Recently, in an RCT, Saini et al (14) concluded that FE created
with hand files increased the intensity of postoperative pain. To the best
of our knowledge, the incidence of postoperative pain after FE with a
continuous rotary system has not been assessed yet.
This RCT was conducted to evaluate postoperative pain after the
use of ProTaper Next rotary files (Dentsply Tulsa Dental Specialties,
Tulsa, OK), a continuous rotary system. The following was the primary
research question: ‘‘What is the effect of FE created with a continuous
rotary system on postoperative pain in patients with necrotic pulp
and apical periodontitis?’’ The null hypothesis was that there would
be no differences in the level of postoperative pain between the 2 inter-
ventions.
Materials and Methods
This study is a randomized, controlled, single-blinded, and single-
center clinical trial. It was designed and reported by adhering to the
Consolidated Standards of Reporting Trials statement (15). This study
was approved by the Ethics Committee of Yakin Dogu University (ref.
no.: 2016/37-274), and the study protocol was registered in the
www.clinicaltrials.gov database with identifier number NCT02770053.
All participants received written information about the trial and pro-
vided written informed consent for study participation.
Participants
From February to August 2016, consecutive patients referred for
endodontic treatment were screened for enrollment at the Isparta State
Hospital, Isparta, Turkey. After comprehensive clinical and radiologic
examinations, 96 consecutive subjects, aged 21–45 years, were
enrolled in the study (Fig. 1).
Screened for eligibility
(n = 96)
Enrollment
Randomized (n=70)
Allocated to the Foraminal
Enlargement group (n=35) Allocation
Lost to follow-up day 7
Follow-up
(n=0)
Analyzed (n=35)
Analysis
Figure 1. Consolidated Standards of Reporting Trials flow diagram showing the progress of subjects at each stage of the clinical trial.
360 Yaylali et al.
Only patients who had maxillary or mandibular molar teeth with
pulp necrosis and radiographic evidence of apical periodontitis (min-
imum lesion size: 2  2 mm) were included. The exclusion criteria
were pregnancy, systemic disorders, preoperative pain, treatment
with antibiotics in the past 1 month, and analgesic treatment within
the past 3 days. The baseline data of the patients were obtained before
the randomization. Only 1 tooth per patient was included in the study.
The power analysis was performed on the basis of the minimum
clinically significant difference in the visual analog scale (VAS) score.
The result of the sample size calculation showed that 35 subjects would
be required in each group to detect clinically significant differences in
pain, with an alpha risk of 0.05, power of 0.8, and standard deviation of
0.75 (14).
Sequence Generation and Blinding
The randomization sequence was created with a computer
random table number generator (www.random.org) with a 1:1 alloca-
tion ratio. The participants were randomized into an FE group or an NFE
group. Because of the nature of the interventions, the operator (I.E.Y.)
was not blinded to the interventions. However, the patients were blinded
and not informed of the allocation. In this RCT, the outcome assessors
were the patients themselves. The success of blinding was tested by
asking the patients to guess their study groups (16). All participants
(N = 70 [100%]) reported that they were not able to guess their study
groups. The allocation sequence was placed in sequentially numbered,
sealed, and opaque envelopes. To prevent the disruption of the alloca-
tion sequence, the names and dates of birth of the patients were written
on the envelopes. Before treatment, the operator opened the sealed en-
velopes in which the type of intervention method was noted.
Interventions
All endodontic treatments were performed by the principal inves-
tigator (I.E.Y.) during a single visit using a standardized treatment pro-
tocol. The vitality of pulp was determined using a hot and cold test and
confirmed visually by the absence of bleeding when entering the pulp
chamber. In all cases, rubber dam isolation was maintained. Patients
Reason of exclusion (n=26)
• Lesion size was less than 2x2 mm (n=5)
• Preoperative pain (n=4)
• Pregnancy (n=1)
• Preoperative analgesic usage (n=9)
• Systemic disorder (n=1)
• Refused to participate (n=6)
Allocated to the Non-foraminal
Enlargement group (n=35)
Lost to follow-up day 7
(n=0)
Analyzed (n=35)
JOE — Volume 43, Number 3, March 2017

were administered local anesthesia (2% lidocaine hydrochloride with
epinephrine 1:100,000) as needed for comfort. Both study groups un-
derwent the same protocol, except for the working length (WL) used.
FE Group. The standard treatment procedure was as follows: the ac-
cess cavity was prepared using sterile carbide burs. For coronal
shaping, low-speed Gates-Glidden burs (Dentsply Maillefer, Ballaigues,
Switzerland) were used. A glide file was established with a size 8 hand K-
file (Dentsply Maillefer). The WL to the apical constriction was
confirmed using an electronic apex locator (EAL) (Root ZX; J Morita,
Tokyo, Japan) and verified radiographically. In this group, instrumen-
tation was performed to the WL maintained at the ‘‘APEX’’ reading (0.0)
of the EAL. Thus, the apical constriction was intentionally and mechan-
ically enlarged. All root canals were instrumented using the ProTaper
Next files (Dentsply Maillefer). Next, X1 (size 17, 0.04 taper) and X2
(size 25, 0.06 taper) files were used to sequentially enlarge the root ca-
nals using a continuous rotary movement at a speed of 300 rpm and a
torque of 2 Ncm powered by the VDW Silver motor (VDW, Munich, Ger-
many). Between each instrument, the canals were irrigated with 2.5%
sodium hypochlorite using a 30-G irrigation needle (Max-i-Probe,
Dentsply Maillefer) up to 2 mm short of the final WL. Apical patency
in both groups was maintained using a size 8 stainless steel hand K-
file (Dentsply Maillefer) by passing 1 mm beyond the WL. All teeth
were irrigated with the same volume of irrigant. The final irrigation
was performed using 2.5% sodium hypochlorite and 5% EDTA.
NFE Group. In the NFE group, all efforts were made to avoid passing
the WL during treatment. In this group, the root canals were prepared to
a WL maintained 1 mm short of the ‘‘APEX’’ reading (0.0). The WLs were
also verified radiographically.
All teeth were dried using ProTaper Next absorbent paper points
(Dentsply Maillefer). Next, the canals were filled using gutta-percha
cones of the ProTaper Next system and AH Plus sealer (Dentsply Mail-
lefer) using a continuous-wave condensation technique. The treatments
were completed by restoring the access cavities with a dentinal adhesive
and composite resin (Filtek P60; 3M Dental Products, St Paul, MN). All
patients were instructed to take an analgesic (400 mg ibuprofen) if they
experienced pain.
Outcomes
We tested the hypothesis that enlargement of the apical foramen in
teeth with necrotic pulp and apical periodontitis would increase post-
operative pain. The primary outcome was the proportion of patients
with postoperative pain during the 7-day follow-up period, and the sec-
ondary outcome was to determine the use of analgesics. The patients
recorded days (7 days of follow-up) with symptoms.
Assessment of Pain and Quality of Life
Postoperative pain intensity was assessed for the first 7 days after
endodontic treatment by using a VAS. The VAS consisted of a 100-mm
line with 2 end points representing ‘‘no pain’’ and ‘‘pain as bad as it
could possibly be.’’ Patients were asked to rate their pain by placing
a mark on the line corresponding to their current level of postoperative
pain. The distance along the VAS line from the ‘‘no pain’’ marker was
then measured with a ruler, giving a pain score out of 100 (17–19).
A higher score meant greater pain severity. Pain severity was assessed
as no pain (0–4 mm), mild pain (5–44 mm), moderate pain (45–
74 mm), and severe pain (75–100 mm) (20). In addition, the partic-
ipants were asked to rate their quality of life on a quality of life scale
(QOLS), which is a measure of function for people with pain (21).
In this 10-point scale, 0 means nonfunctioning (stay in bed all days),
JOE — Volume 43, Number 3, March 2017
CONSORT Randomized Clinical Trial
and 10 means normal quality of life (go to work and perform normal
daily activities every day).
Statistical Analysis
For the primary and secondary outcomes, all participants were
analyzed based on an ‘‘intention-to-treat’’ principle in which they
were analyzed according to their original treatment assignment, and
all events were counted against the assigned treatment. Baseline de-
scriptors were also compared. All statistical analyses were conducted
using SPSS v.20.0 (IBM Corp, Armonk, NY).
The Shapiro-Wilk test was used to assess whether the VAS values
were normally distributed. Because all data showed normal distribution
(P > .05), the Student t test, a parametric statistical analysis, was used
for analyzing independent samples. The chi-square test was used to
evaluate the differences between categoric variables. The comparisons
were considered significant if P < .05.
Results
Table 1 shows the demographic and baseline characteristics of the
participants. No statistically significant differences existed between the
study groups at baseline (P > .05). In this study, 96 patients were
screened. Of these, 20 were excluded, and 6 declined participation.
There was no loss of participants during follow-up.
Primary Outcome
The pain intensity was significantly different between the groups
during the first 2 days (P < .05, independent samples t test), after which
it was nonsignificant. The mean pain scores in the FE group remained
higher than those in the NFE group throughout the study (Table 2).
In the FE group, on the first day, 12 patients (34%) had severe
postoperative pain, and 23 patients (66%) had moderate pain. On
the second day, 11 patients (31%) had severe postoperative pain,
and 24 patients (69%) had moderate pain. In this group, no significant
difference was observed in the pain level between the first 2 days
(P > .05, paired samples t test). In the NFE group, the patients had mod-
erate pain in the first 2 days. Figure 2 shows details of postoperative pain
during the follow-up period in both groups.
No flare-up or serious adverse effect occurred in this RCT during
the follow-up period (0%). No patients needed an additional or un-
scheduled visit for the severity of their postoperative pain. No significant
difference was observed in the QOLS of the patients (P > .05). All but 1
patient had a QOLS score of 10; 1 patient in the FE group had a score of
9, representing ‘‘limited outside social activities.’’
Secondary Outcome
No significant difference was observed in analgesic consumption
between the groups (P > .05). Nine patients (26%) in the FE group
and 6 patients (17%) in the NFE group needed to use analgesics in
the first 2 days.
Discussion
This RCT was conducted to evaluate whether creating an FE using a
continuous rotary system has an effect on postoperative pain. The find-
ings indicated that postoperative pain was significantly higher in the FE
group in the first 2 days when compared with the NFE group. Therefore,
the null hypothesis was rejected. The target population of this RCT was
adult patients with necrosis and apical periodontitis of their molar teeth.
No statistically significant difference in sex and age was noted between
the groups. Only asymptomatic patients were included because preop-
erative pain may influence the outcomes and threaten the legitimacy of
Foraminal Enlargement and Postoperative Pain 361
CONSORT Randomized Clinical Trial
TABLE 1. Participants’ Demographic and Baseline Characteristics Junior et al (13), who found more pain at 24 hours after enlargement
of the apical foramen created with reciprocating files. This difference
Chacteristic FE (n = 35) NFE (n = 35) P value
can be attributed to the different systems used; Cruz Junior et al’s study
Age, mean  SD years 32.3  7.1 34  7.5 .35 (13) used a reciprocating system, whereas our study used a continuous
Sex, n (%) .63
Women 21 (35) 19 (53) —*
rotary system, which has a different movement. The overall level of post-
Men 14 (65) 16 (47) — operative pain in the present study was higher than that in previous
Education, n (%) .34 studies. This difference can be attributed either to the continuous rotary
<11 years 1 (3) 4 (11) — system or the VAS scale used in the present study. Our findings also re-
11–14 years 29 (83) 25 (71) — vealed that enlarging the apical foramen did not influence the analgesic
>15 years 5 (14) 6 (17) —
Marital status, n (%) .47 consumption by the patients. This finding is similar to the results of pre-
Single 17 (49) 14 (40) — vious studies (12–14).
Married 18 (51) 21 (60) — Postoperative pain can be defined as any degree of pain that begins
Work status, n (%) .64 after the initiation of endodontic therapy, whereas flare-up is defined as
Working 15 (43) 16 (46) —
Homemaker 8 (23) 5 (14) —
the initiation or continuation of pain and/or swelling after a root canal
Student 12 (34) 14 (65) — treatment that upsets the patient’s quality of life such that the patient
Smoking 14 (40) 18 (51) .33 needs an additional and unscheduled visit (27). Therefore, flare-up
VAS, initial 0 0 1.0 is a subset of postoperative pain wherein the patient reports a high de-
Teeth, n (%) .81 gree of pain that disturbs his or her quality of life (10). Previous studies
Mandibular molar 15 (43) 16 (46) —
Maxillary molar 20 (57) 19 (54) — have reported low flare-up rates of 3% (28), 1.9% (29), and 0% (12)
Systemic disease 0 0 1.0 in 1-visit endodontic treatment. In present study, no flare-up occurred
(0%). Twelve patients (34%) experienced severe pain (FE, >74 mm).
FE, foraminal enlargement; NFE, nonforaminal enlargement.
Of these, 9 controlled their pain using analgesics. None of these patients
*Dashes indicate no P value.
needed an unscheduled visit. None of the patients reported a decrease in
the quality of life. Interestingly, 3 patients did not take medicine
the findings. Because studies have shown the presence of a microbial although they reported severe pain. No significant difference was found
biofilm not only within the apical part of the root canal system but in analgesic consumption between the groups. This finding is in agree-
also within the apical lesion itself (3, 5), only teeth with necrosis and ment with those of previous studies (12, 28).
apical periodontitis were included in this RCT. Saini et al (14) reported that pain was higher in the FE group than
A VAS model was used for outcome assessment. VAS is a simple model in the NFE group in the first 6 days. This finding is in contrast with that of
and has been reported to be 1 of the most commonly used measures of the present study in which postoperative pain was higher in the FE group
pain intensity in pain research (20). Thus, in this study, VAS was used, in the first 2 days. This difference could be because Saini et al placed
and the points marked by the patients were measured with a ruler (20). calcium hydroxide in the canal. Furthermore, they completed endodon-
Determining the WL is a pivotal step in endodontic treatment. In a tic treatments over 2 visits, whereas the present study used a 1-visit
systematic review, it was suggested that the WL should be determined approach. A possible intracanal medicament extrusion may have
using an EAL and be verified radiographically to minimize the chances increased the pain. Indeed, a systematic review indicated that the num-
of error (22). Therefore, Root ZX (J Morita), which is used commonly ber of visits may influence the incidence of postoperative pain (30). In
in accuracy studies and is reported to be highly efficient and reliable addition, the pain scales used in the 2 studies were different.
under different conditions, was used (23, 24). WLs were also Silva et al (12) indicated that FE created in anterior teeth with hand
confirmed radiographically. files did not significantly increase the pain. This finding is in contrast with
In this RCT, root canal treatments were performed using a contin- that of the present study in which FE in molar teeth increased the pain in
uous rotary system. Thus far, several studies have assessed postopera- the first 2 days. This difference could be because Silva et al evaluated only
tive pain after endodontic treatment using reciprocating or rotational anterior teeth with a single canal, whereas the present study treated molar
instruments. In a recent RCT, Kherlakian et al (25) indicated no signif- teeth, which have canals with a more complex anatomy (28).
icant difference in postoperative pain between reciprocating and
continuous rotary systems. Nekoofar et al (26) reported that endodon- Generalizability of the Findings
tic treatment with reciprocating files causes more postoperative pain This study was conducted in a general population, and its results
when compared with that with a continuous rotary system. On the other can be generalized to other populations. Information on generalizability
hand, Cruz Junior et al (13) reported that FE created with a recipro- is shown by the demographic characteristics of the study participants.
cating system led to a low incidence of pain. However, the effect of FE The researchers can assess whether they are likely to observe similar
created using a continuous rotary system remains unknown. findings in their participant populations. We believe that the outcomes
Our findings indicated that FE created with a continuous rotary sys- of this RCT, which evaluates the effect of FE in patients with necrotic pulp
tem caused more pain in the 48-hour post-treatment period. This dura- and apical periodontitis, can be extrapolated to other populations as
tion of pain found in our study is longer than that reported by Cruz well.

TABLE 2. The Mean and Standard Deviations of Visual Analog Scale Pain Values
Group Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 Day 7
FE group 72.97  3.61 72.71  2.78 44.57  3.78 35.14  2.11 27.60  1.35 21.03  2.52 2.40  1.41
NFE group 64.66  2.47 52.97  1.88 43.26  2.60 34.63  2.28 27.23  1.33 21.06  1.87 2.09  1.29
P value .000 .000 .095 .333 .251 .957 .336
FE, foraminal enlargement; NFE, nonforaminal enlargement.

362 Yaylali et al. JOE — Volume 43, Number 3, March 2017


Figure 2. Mean VAS values (mm).
Limitations and Strengths
The present study had several limitations and strengths. First, non-
blinding of the operator may be a limitation although a large experi-
menter bias is unlikely. Second, different pain thresholds among the
participants may affect VAS values. We evaluated the patient-reported
outcomes. On the other hand, the selection bias was considered to
be minimized because of the generation of a suitable randomized
sequence. Similarly, the performance bias was considered to be mini-
mized because the blinding of participants was ensured during the
study. Finally, there was low risk of detection bias because the blinding
of the outcome assessment was ensured during the study.
Implications for Research and Clinical Practice
It would be worthwhile to investigate whether enlarging the apical
foramen has a higher success rate. Therefore, observational follow-up
cohort studies are needed to determine the long-term effects of FE.
Furthermore, it seems reasonable to perform an RCT that compares
the effect of FE created with a continuous rotary system or reciprocating
system on postoperative pain. Moreover, because RCTs performed so
far have reported conflicting findings, there is a need for a systematic
review that pools the findings of these studies.
In conclusion, within the limitations of this study, participants in
the FE group had more severe pain in the first 2 days than those in
the NFE group. Although 30% of the participants in the FE group expe-
rienced severe pain, none of these patients needed an additional or un-
scheduled visit.
Acknowledgments
The authors deny any conflicts of interest related to this study.
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