Clinical Research
Fracture Incidence of WaveOne and Reciproc
Files during Root Canal Preparation of up to 3
Posterior Teeth: A Prospective Clinical Study
ovis Stephano Pereira Bueno, DDS, MSc,* Daniel Pinto de Oliveira, DDS, MSc, PhD,
Cl

Rina Andrea Pelegrine, DDS, MSc, PhD,* Carlos Eduardo Fontana, DDS, MSc, PhD,*
Daniel Guimar~ aes Pedro Rocha, DDS, MSc, PhD,*
and Carlos Eduardo da Silveira Bueno, DDS, MSc, PhD*
Abstract
Introduction: Reciprocating instruments were devel-
oped to improve and simplify the preparation of the
root canal system by allowing greater centralization of
the canal and requiring a shorter learning curve. Despite
the risk of instrument separation, using a reciprocating
instrument in more than 1 case is a relatively common
clinical practice. The aim of this study was to evaluate
the fracture resistance of Reciproc (R25; VDW, Munich,
Germany) and WaveOne (Primary; Dentsply Maillefer,
Ballaigues, Switzerland) instruments according to the
number of uses during the preparation of root canals
in up to 3 posterior teeth. Methods: A prospective clin-
ical study was conducted by 3 experienced specialists
who performed treatment of 358 posterior teeth (1130
canals) over a period of 12 months using 120 recipro-
cating instruments, 60 of which were Reciproc R25
and 60 were WaveOne Primary. The motion used during
instrumentation followed the recommendations of the
respective manufacturers. After each use, the instru-
ments were observed under a dental operating micro-
scope at 8 magnification. In the case of fracture or
deformation, the instrument was discarded. Results:
None of the instruments showed any signs of deforma-
tion, but 3 instruments fractured (0.26% of the number
of canals and 0.84% of the number of teeth). All frac-
tures occurred in mandibular molars (1 WaveOne Pri-
mary file during the third use and 2 Reciproc R25 files,
1 during the first use and the other during the third
use). Conclusions: There was a low incidence of frac-
ture when reciprocating files were used in up to 3 cases
of endodontic treatment in posterior teeth. (J Endod
2017;43:705708)
From the *Department of Endodontics, S~ao Leopoldo Mandic Dental Research Center, Campinas, S~ao Paulo, Brazil; and Federal University of Alagoas and Cesmac
University Center, Macei
o, Alagoas, Brazil.
Address requests for reprints to Dr Carlos Eduardo da Silveira Bueno, Rua Ant^onio Lapa, 854, Campinas, SP, Brazil 13025-241. E-mail address: carlosesbueno@terra.
com.br
0099-2399/$ - see front matter
Copyright 2017 American Association of Endodontists.
http://dx.doi.org/10.1016/j.joen.2016.12.024
JOE Volume 43, Number 5, May 2017
Key Words
Instrument fracture, posterior teeth, Reciproc, reciprocating movement, WaveOne
T he introduction of Wave-
One (Dentsply Maillefer,
Ballaigues, Switzerland) and
Signicance
In this study, Reciproc and WaveOne les were
used safely for up to 3 clinical cases of endodontic
Reciproc (VDW, Munich,
treatment in posterior teeth with a fracture rate
Germany) systems in end-
comparable with that observed in studies on
odontic practice enabled
single-use reciprocating instruments.
preparation of root canals
using the single-file concept
(1). Single-file reciprocating systems are advantageous because they require a shorter
learning curve, simplify the endodontic instrumentation process, and are more cost-
effective compared with full-sequence rotary systems (2, 3). Furthermore, reciprocating
motion has been proven to be safer both in respect to cyclic fatigue and torsion
fracture (4). As a result, the life span of the instruments used with this motion has
been proven to be longer (5).
The number of times an endodontic file can be used is a highly controversial topic
in the related literature. According to the manufacturers, instruments must be disposed
of after the first use, a recommendation confirmed by Kim et al (6). According to these
authors, contraindications for the reuse of reciprocating instruments would be that in-
strument damage is cumulative and that there is no guarantee that the reciprocating mo-
tion programmed in the motor driving the instrument will maintain its action within the
elastic range of the material.
However, it seems reasonable to assume that the wear suffered by an instrument
when used in a tooth with only 1 canal is less than that observed when it is used in a tooth
with 3 canals. Based on this reasoning, one could admit the possibility of using the same
reciprocating instrument in more than 1 case, particularly in environments in which the
high cost of instruments can hinder or preclude treatment altogether.
The thermal treatment of the NiTi alloy used in reciprocating instruments has been
linked to a low incidence of fractures. Gambarini et al (7) showed that this treatment
imparts enhanced flexibility and resistance to cyclic fatigue compared with instruments
made of conventional NiTi alloy. Furthermore, in the kinematics of reciprocating sys-
tems, the instrument does not complete a full 360 turn continuously, thus reducing
taper lock and the overall risk of torsion fracture (2, 4, 811).
Fracture of WaveOne and Reciproc Files 705
Clinical Research
Another contraindication to reusing reciprocating instruments,
according to the manufacturers, is the difficulty involved in guarantee-
ing their proper sterilization. However, this difficulty was not observed
by Raju et al (12), who evaluated different methods of sterilization for
endodontic files (autoclaving, sterilization with carbon dioxide laser,
chemical sterilization with glutaraldehyde, and glass bead sterilization)
and concluded that sterilization by autoclaving is effective.
Nevertheless, because the Reciproc and WaveOne reciprocating
systems were designed for single use, manufacturers have installed a sil-
icone ring at the end of the instruments coupling shank. Thus, when the
instrument is sterilized, the ring expands from the heat, precluding a
new coupling to the contra-angle and thereby making it difficult to
reuse.
Pirani et al (5) conducted a scanning electron microscopic study
to evaluate the surface changes that had occurred after the third sequen-
tial use of reciprocating instruments (Reciproc R25 [VDW] and Wave-
One Primary [Dentsply Maillefer]) in single-rooted extracted teeth and
found that both instruments presented only limited changes, such as
deformation of the tip and a certain degree of surface wear. Under an
optical microscope, no signs of plastic deformation were observed.
Thus, the authors concluded that both files were safe for use in the end-
odontic treatment of multirooted teeth.
There are certain socioeconomic settings in which the use of
reciprocating systems may not be considered a viable option because
of their cost or are otherwise not considered the best choice in terms
of health economics. Furthermore, although the multiple use of recip-
rocating instruments is a reality (whether in more than 1 tooth or in
more than 1 root in a single tooth) and has been preliminarily investi-
gated, no clear standardized protocol for it is yet available. To date, and
to the best of our knowledge, no clinical study has been conducted to
evaluate the fracture rate of reciprocating instruments used for more
than 1 clinical case of multirooted teeth. Thus, with the aim of shedding
light on deciding whether reciprocating instruments should be used in
more than 1 clinical case of multirooted teeth, this study evaluated the
fracture resistance of the Reciproc R25 and WaveOne Primary instru-
ments according to the number of uses during the preparation of
root canals in up to 3 posterior teeth.
Materials and Methods
The study protocol was approved by the institutional research
ethics committee (opinion no. 560.834). An ex vivo pilot study was
conducted to establish our methodology and protect patients from
possible unforeseen risks. It involved using 12 extracted teeth and
the same instrument types and number of uses used in the main study.
Three endodontic specialists working routinely with the WaveOne
and Reciproc systems for over 4 years performed all the clinical proced-
ures. The operators and researchers discussed and agreed upon a writ-
ten protocol for all treatment and evaluation procedures as described
later. Any required deviation from this protocol because of individual
clinical circumstances or patient needs prompted the exclusion of
the case from the study sample.
A sample size calculation was performed using Cochrans method.
Based on a type I error of 0.05, a sample size of 385 would be required
to detect differences between the 2 study groups. Therefore, a total of
386 molars and premolars were selected from patients who sought
care from the endodontists involved in the study.
The teeth had indications for conventional endodontic treatment
for curative or prosthodontic purposes. Patients having teeth with
incomplete root formation, curvatures greater than 45 (13), calcified
canals, canals with a radiographically visible double curvature, and pre-
vious endodontic treatment were excluded from the study.
706 Bueno et al.
During the study, dropouts accounted for a total of 26 teeth, leav-
ing a final sample of 360 teeth for which a total of 120 instruments were
assigned to perform the treatment. Thus, each of the 60 WaveOne Pri-
mary and 60 Reciproc R25 instruments were used to treat 3 teeth,
totaling 180 cases treated using each of the studied systems.
The choice of the file to be used in each case was determined at
random using software available at www.random.org. Numbers 1
through 6 were used to assign instruments to cases as follows: 1: Primary
file, first use; 2: Primary file, second use; 3: Primary file, third use; 4: R25
file, first use; 5: R25 file, second use; and 6: R25 file, third use.
Access was obtained conventionally with spherical diamond burs
with sizes compatible with the volume of each pulp chamber used at
high speed. Once the form of convenience was established, isolation
was conducted, and straight-line access to canal orifices was obtained
with CPR 3D ultrasonic inserts (Obtura Spartan, Algonquin, IL) under
8 magnification. The canals were explored with K-type #08 or #10
hand files (Dentsply Maillefer) depending on the initial diameter of
the foramen and the degree of curvature of the canal using a watch-
winding motion up to 2 mm short of the initial length of the tooth.
Afterward, the cervical third of the root canals was prepared with a
reciprocating instrument, either WaveOne (Primary) or Reciproc
(R25), using 3 in-and-out movements and incorporating a brushing ac-
tion of the instrument against the canal walls followed by irrigation with
5 mL 2.5% sodium hypochlorite. The middle third was then prepared as
performed for the cervical third.
The working length (WL) was established 1 mm short of the apical
foramen using a Mini Root ZX II electronic foraminal locator (J Morita
Corp, Fushimi-ku, Kyoto, Japan). Then, the apical third of the root ca-
nals was prepared, repeating the same movement until reaching the WL,
and verified with a #25 K-type file.
A total of 25 mL irrigating solution was dispensed with a 24-G nee-
dle (Max-I-Probe; Dentsply Tulsa Dental, York, PA) during access and
with a 31-G NaviTip needle (Ultradent Products Inc, South Jordan, UT)
when reaching the WL after each file insertion. The canals were kept
filled by the irrigating solution, which was continuously renewed.
The instruments were driven by a VDW Silver Reciproc electric
motor in Reciproc All and WaveOne All modes (preprogrammed
speed and torque), respectively, for Reciproc and WaveOne instru-
ments. Foramen patency was checked with a #10 K-type file inserted
1 mm beyond the tooths real length and was maintained during the
entire instrumentation procedure.
Whenever apical enlargement was needed at the end of the recip-
rocating instrumentation of the apical third, as in palatine and distal ca-
nals, this was done with large or R40 files (Reciproc) depending on the
system previously used for root canal preparation. After completing the
canal shaping procedure, irrigation/aspiration was performed with
5 mL 17% EDTA. This solution was maintained in the root canal for
3 minutes followed by irrigation with 5 mL 2.5% sodium hypochlorite.
Final suction was performed with a capillary tip (25.0  0.35 mm). The
canals were dried with absorbent paper cones.
All the instruments were observed with a dental operating micro-
scope (Opmi Pico; Carl Zeiss, Gottingen, Germany) under 8 magni-
fication after each use. The following visual criteria were adopted to
control how many times the instruments were used:
1. First-use files: instruments that were used immediately after being
removed from the original manufacturer blister, still having an intact
silicone ring. After the first use, these instruments underwent a
cleaning process in an ultrasonic bath with an enzymatic detergent
for a period of 20 minutes. Afterward, they were placed in individual
packages and sterilized by autoclaving at 134 C for 24 minutes
(2340EK; Tuttnauer USA Co, Hauppauge, NY).
JOE Volume 43, Number 5, May 2017
 Clinical Research
TABLE 1. Number of Cases Treated in Relation to the Total Number of Teeth Treated (N = 358) according to Tooth Type and Number of Canals
Number of cases according to
Number of cases according to tooth type, n (%) number of canals, n (%)
1st 2nd 1st 2nd 1 2 3 4
maxillary maxillary mandibular mandibular Canal Canals Canals Canals Total
Premolars 38 (10.61) 22 (6.15) 7 (1.96) 4 (1.12) 25 (0.07) 46 (0.12) 71 (19.83)
Molars 103 (28.77) 56 (15.64) 91 (25.42) 37 (10.34) 135 (37.70) 152 (42.45) 287 (80.16)

2. Second-use files: instruments that were removed from the steriliza-
tion package and still had their original silicone ring. Deformation of
the ring from the sterilization process identified its second use and
required that the ring be removed with a sterile scalpel blade for the
file to be reused. A new sterilization cycle was performed after reuse
as previously described.
3. Third-use files: instruments that, after sterilization and before reuse,
were already in the packaging without the silicone ring.
At the end of the consultation, operators completed a question-
naire with information related to the case including details of any frac-
tures or deformities, such as fractured instrument, fragment size,
fracture location, number of uses before fracture, and the success or
otherwise of the bypass or fragment removal procedure. The results
were tabulated, and a statistical description was performed in percent-
age terms. The near-zero value observed for the occurrence of the stud-
ied event (fracture) made it impossible to conduct any meaningful
statistical analysis.
Results
No fractures were observed in the ex vivo pilot study. A statistical
description of the cases included in the main study is shown in Table 1.
The number of fractures, the number of uses after which the observed
fractures occurred, the fracture position in terms of canal third, the
fragment size, and the fragment management adopted are shown in
Table 2. Among the 1130 treated root canals, there were 3 fractures
(0.26%), all of which occurred in mandibular molars. The percentage
of fractures in relation to the number of teeth was 0.84%. No deforma-
tions were observed under 8 magnification using a dental operating
microscope.
Because the 1 Reciproc file (R25) fractured during its first use, the
total number of treated cases became 358 (because there were no sec-
ond and third uses for this file, 2 cases were deducted from the initial
total of 360 cases).
Discussion
According to the manufacturers, reciprocating instruments must
be disposed of after a single use; this recommendation was endorsed
by Kim et al (6). However, if one recognizes that the wear undergone
by an instrument during its use in a single-rooted tooth is likely less
intense than that resulting from its use in a multirooted tooth, one
must also admit the possibility of using a single reciprocating instrument
in more than just 1 case, particularly in certain less favorable socioeco-
nomic settings. Although the manufacturers of reciprocating instru-
ments recommend that they be used only once and then discarded,
reusing these instruments has become a common practice that seems
to be supported by recent investigations (5, 14).
After using the Primary and R25 reciprocating instruments in 3
cases of single-rooted teeth, Pirani et al (5) concluded that both are
safe for use in a case of a multirooted tooth. In the present clinical study,
the authors went a step beyond and investigated whether reciprocating
instruments could be used with comparable safety in up to 3 clinical
cases of posterior teeth.
Gavini et al (15) evaluated the R25 file and noted that recipro-
cating instruments supported a significantly greater number of cycles
before fracturing compared with continuous rotation instruments.
Kim et al (16) used scanning electron microscopy to evaluate the
shaping ability of a ProTaper F2 file (Dentsply Maillefer) compared
with that of a WaveOne Primary file, both in reciprocating motion.
They also assessed the resistance of both instruments to cyclic fatigue
after instrumentation. The results showed no difference in terms of
shaping ability, but the WaveOne system proved more resistant to cyclic
fatigue. Kiefner et al (17) assessed the cyclic fatigue fracture resistance
of 2 NiTi systems (Reciproc R25 and R40 and Mtwo 25.07 and 40.04
[VDW]) both in rotary and reciprocating motion and found that the Re-
ciproc instruments used with reciprocating motion withstood a greater
number of cycles before fracture followed by Mtwo instruments in
reciprocating motion, Reciproc in rotary motion, and Mtwo in rotary
motion. The authors concluded that continuous rotation instruments
withstood fewer service cycles than reciprocating instruments before
fracturing.
Based on these data and because the continuous rotation instru-
ments studied are, in principle, reusable, it seems reasonable to accept
the possibility of reusing reciprocating instruments. That is why the in-
struments in the present clinical study were used for up to 3 cases of
endodontic treatment on posterior teeth.
Observation of the instruments in the present study was performed
with a dental operating microscope under 8 magnification after each
use following the procedure adopted by Pirani et al (5), who evaluated
R25 and Primary files used for 3 cases of extracted single-rooted teeth.
As also found by these authors, no plastic deformation was detected in
the instruments used.
As a trial for the present study and to protect patients from
possible unforeseen operative risks, an ex vivo pilot study was con-
ducted with 12 extracted teeth selected according to the same

TABLE 2. Number of Fractures in Relation to the Total Number of Canals Treated (N = 1130) according to the Instrument System When the Fracture Occurred
(First, Second, or Third Time Used) and Fracture Position
Number of When the fracture Fragment Fragment
fractures, n (%) occurred Fracture position size management Total, n (%)
Reciproc 2 (0.17) 1st time used Middle third 8 mm Removed 3 (0.26)
3rd time used Apical third 3 mm Bypassed
WaveOne 1 (0.09) 3rd time used Apical third 4 mm Bypassed

JOE Volume 43, Number 5, May 2017 Fracture of WaveOne and Reciproc Files 707
Clinical Research
inclusion/exclusion criteria and was concluded with no case of in-
strument fracture. In the main study, which was performed with
the same number of Reciproc and WaveOne instruments, 1130 ca-
nals (358 teeth) were treated, rendering a mean of 9.4 canals
treated per file and an overall fracture rate of 0.26% (0.84% of
the number of teeth). In a clinical study to evaluate the incidence
of fractures and deformations of Reciproc instruments, Plotino
et al (18) obtained a low fracture rate (8 instances, 0.47% of instru-
ments and 0.21% of canals treated) after following the manufac-
turers recommended protocol (no glide path preparation).
Furthermore, the instruments were also used for retreatment proced-
ures (in which 3 of the total of 8 fractures occurred). Cunha et al
(19) conducted a clinical study using WaveOne files to treat a total of
2215 canals (711 teeth) and also obtained a low fracture rate. There
were 3 instrument separations (two 21.06 and one 25.08), yielding
a fracture rate of 0.13% (0.42% of the number of teeth). Neverthe-
less, the instruments were used only once, and Gates-Glidden burs
were used for cervical preflaring (a procedure not recommended
by the manufacturer). Therefore, both Plotino et al (18) and Cunha
et al (19) studied the behavior of reciprocating instruments after sin-
gle use, and yet their fracture rate results were comparable with ours
in which each instrument was used for the preparation of 3 poste-
rior teeth.
Ehrhardt et al (14) conducted a clinical study of the Mtwo rotary
system used up to 5 times on posterior teeth and obtained a fracture
rate of 1.98% of treated teeth. In the present study, the fracture rate
relative to the number of teeth treated was even lower (0.84%), and
the comparison further favors reciprocating instruments because no
hand files or Gates-Glidden burs were used for preflaring of the cer-
vical and middle thirds of the root canal, as was the case in the study
by Ehrhardt et al. Arguably, although reciprocating instruments are
relatively costlier when considered individually, they have a lower
overall cost in that a single reciprocating instrument is used per
case versus multiple rotary files and occasionally preflaring files, not
to mention the lower operative time required for treatment completion
and the shorter learning curve (20).
In the present study, all fractures occurred in mandibular molars.
The first-use fracture occurred during preparation of the middle root
third and the 2 third-use fractures during apical preparation. These re-
sults confirm the study by Cheung (21), according to which the curva-
ture between the middle and apical thirds of the roots of these teeth is
the site most conducive to the occurrence of fractures.
Kim et al (4) and Plotino et al (11) conducted laboratorial studies
and showed that the Reciproc R25 instrument has a smaller metallic
core and therefore lower torsional resistance compared with the Wave-
One Primary instrument. This could explain the fracture of the Reciproc
R25 instrument during its first use as observed in the present study. As
for cyclic fatigue, Arias et al (22) concluded that Reciproc R25 would be
more resistant than WaveOne Primary, both at 5 mm and 13 mm away
from the tip toward the shank. Like the findings of these studies, the
fragment of the R25 instrument that broke off during its first use in
the present study was 8 mm.
The clinical experience gained during the period of this study in-
dicates that the evaluated instruments can be safely used in up to 3 clin-
ical cases of endodontic treatment in posterior teeth. Therefore, this
could be an interesting alternative whenever it is necessary to apportion
the cost of these instruments among up to 3 patients.
This result can also be regarded as further confirmation of the
safety of reciprocating instruments when used by professionals who
708 Bueno et al.
choose to use these files only once based on the manufacturers
recommendation. New studies, ideally with larger samples, are recom-
mended to confirm the safety of using reciprocating instruments in mul-
tiple clinical cases of posterior teeth.
In conclusion, within the limitations of this prospective clinical
study, the use of Reciproc (R25) and WaveOne (Primary) files in up
to 3 cases of posterior teeth produced a low fracture rate, thus proving
a viable option in cost-sensitive environments.
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JOE Volume 43, Number 5, May 2017