Assessment of the Separation Incidence of Reciprocating

WaveOne Files: A Prospective Clinical Study

Rodrigo Sanches Cunha, DDS, MSc, PhD, FRCD(C),* Alanna Junaid, BSc, DMD, BSc (Dent),*
Pablo Ensinas, DDS, MSc,

William Nudera, DDS, MSc,

and Carlos Eduardo da Silveira Bueno, DDS, MSc, PhD

Abstract
Introduction: Despite metallurgical advancements in
the nickel-titanium le manufacturing process, le sep-
aration remains a concern. The purpose of this prospec-
tive clinical study was to assess the separation incidence
of the reciprocating WaveOne le (Dentsply Tulsa Dental
Specialties, Tulsa, OK) when used to prepare root canals
of posterior teeth. Methods: File separation incidence
was assessed over an 18-month period in which 4 expe-
rienced and calibrated endodontists performed conven-
tional endodontic treatment on posterior teeth using the
WaveOne le system. The separation incidence was
determined based on both the number of teeth and
the number of canals instrumented during this time
period. Results: A total of 2,215 canals (711 teeth)
were treated. Three instruments (two 21.06 and one
25.08) separated during use and were deemed to be
irretrievable. The overall instrument separation inci-
dence in relation to the number of canals shaped was
found to be 0.13% (0.42% teeth). Conclusions: Based
on the results of this study, the incidence of endodontic
instrument separation when using the WaveOne
reciprocating le was considerably low. (J Endod
2014;40:922924)
Key Words
File fracture, nickel-titanium reciprocating instrument,
separation incidence, separation of les, WaveOne
T
he design and mechanical properties of endodontic instruments have advanced
signicantly in recent decades. The introduction of nickel-titanium (NiTi) alloys
has enabled practitioners to work safely inside narrow and curved canals. The use
of an electric motor in rotational and/or reciprocating movements in conjunction
with NiTi instruments has signicantly increased instrumentation efciency while
reducing working time (1). However, the separation incidence of these instruments
is still an area of uncertainty because of the number of studies that offer conicting
results.
In a systematic review, Panitvisai et al (2) assessed the prognosis of teeth in which
instrument separation occurred during endodontic therapy. No signicant decline in
the healing rate was observed in teeth with an irretrievable le when compared with
teeth in which le separation did not occur or in teeth in which the le was successfully
removed. However, the odds of an unfavorable outcome increase when a fractured in-
strument prevents thorough disinfection of the root canal system in the presence of a
preoperative periradicular lesion (3).
In 2010, the WaveOne engine-driven reciprocating system was introduced by
Dentsply Tulsa Dental Specialties (Tulsa, OK). The reciprocating le shapes the root
canal system using an asymmetric back and forth motion whereby the le continually
changes its direction during the canal shaping process. This reciprocating motion con-
sists of a larger degree of rotation in the cutting direction and a smaller degree of rota-
tion in the reverse direction. The system consists of 3 le size options: small (tip size 21
with a constant taper of 0.06), primary (tip size 25 with a taper of 0.08 from D1D3),
and large (tip size 40 with a taper of 0.08 from D1D3). The manufacture of the Wave-
One system proposes the use of only 1 reciprocating le chosen based on canal anat-
omy. The NiTi used to make WaveOne les is manufactured using the M-Wire thermal
treatment process. This provides increased exibility (4, 5) and strength, and high
resistance to cyclic fatigue (6, 7).
Numerous studies have clinically assessed the fracture incidence of NiTi rotary
endodontic instruments (814). However, no clinical studies evaluating the
fracture incidence of reciprocating les have been published to date. Therefore,
the purpose of this prospective clinical study was to assess the separation
incidence of the WaveOne reciprocating le used in root canal preparation of
posterior teeth.
Materials and Methods
The fracture incidence data were collected from a total of 711 posterior teeth of
patients who sought treatment from January 2012August 2013. A specic data le was
completed for each patient in order to obtain the required information. Four endodon-
tists trained in the WaveOne reciprocating technique were included in the study.
After access cavity preparation, straight-line access to the canal orices was
achieved using the Gates-Glidden drills #3 and #2 or an orice opener with similar geo-
metric diameters. A reproducible glide path with apical patency was created using
K-type hand les of small diameter (#08, #10, or #15) and/or PathFile rotary les
#1 (tip size 13 with a taper of 0.02), #2 (tip size 16 with a taper of 0.02), and #3
(tip size 19 with a taper of 0.02) (Dentsply Tulsa Dental Specialties). The instrumen-
tation procedure was performed with the canals ooded and irrigated with copious
From the *Division of Endodontics, University of Manitoba,
Winnipeg, Manitoba, Canada;

Graduate Program in Endodon-
tics, Salta Endodontics Society, Salta, Argentina;

Private Prac-
tice Limited to Endodontics, Bloomingdale, Illinois; and

Division of Endodontics at the CPO-Sao Leopoldo Mandic,

Campinas, S~ao Paulo, Brazil.
Address requests for reprints to Dr Rodrigo Sanches Cunha,
Division Endodontics, Department of Restorative Dentistry,
D226C780 Bannatyne Avenuem, Winnipeg, Manitoba, Can-
ada R3E 0W2. E-mail address: rodrigo.cunha@umanitoba.ca
0099-2399/$ - see front matter
Copyright 2014 American Association of Endodontists.
http://dx.doi.org/10.1016/j.joen.2014.03.016
Clinical Research
922 Cunha et al. JOE Volume 40, Number 7, July 2014
amounts of sodium hypochlorite (NaOCl) in various concentrations
ranging from 2.5%6%.
The working length was determined to be 0.5 mm from the root
apex. This was achieved with the aid of a Root ZX II electronic apex
locator (J Morita Corp, Kyoto, Japan) and conrmed radiographically.
A newle of the appropriate size was selected according to the following
criteria:
1. If a size #10 K-le was resistant to apical advancement, a small le
was selected.
2. If a size #10 K-le passively advanced to the established working
length or t loosely at length, a primary le was selected.
3. If a size #20 hand le or larger passively advanced to the established
working length, a large le was selected.
File selection was individualized for each canal. As such, multiple
les could be used in a single tooth if the canals were of differing diam-
eters as frequently is the case in multirooted teeth. If all canals were the
same size, a single le was used for the complete instrumentation of
1 tooth.
After ooding the canals with NaOCl, the le was inserted and
advanced apically. After 3 consecutive apical pecking movements, the
le was removed from the canal and cleansed of debris using
alcohol-soaked gauze. This process was repeated until the le advanced
to the pre-established working length. After each le insertion, the ca-
nals were irrigated with NaOCl, and patency was conrmed with a #10
or #15 hand le.
Files exhibiting deformation were discarded, and treatment was
completed using a new le of the same size. Final irrigation was per-
formed with 5 mL 17% EDTA in association with sonic activation
(EndoActivator, Dentsply Tulsa Dental Specialties) for 1 minute fol-
lowed by 5 mL NaOCl.
Upon completion of endodontic treatment, the clinician recorded
the appropriate data relating to the tooth type, number of canals treated,
and le(s) used. If separation occurred, a detailed description of the le
used, tooth type, specic canal, and canal level at which le fracture
occurred was recorded.
Results
During the 18-month period in which the 4 clinicians instru-
mented 2,215 canals (711 teeth), 3 le separations occurred. Two of
the 3 were small les, and the other was a primary le. The overall
le separation incidence in relation to the number of canals instru-
mented was found to be 0.13% (0.42% in relation to the number of
teeth). For tabulated data, please refer to Table 1 and Table 2.
Discussion
Despite the numerous improvements made in instrument design
and alloy composition, le separation during root canal shaping re-
mains a concern. This phenomenon can occur at any time without
any visible signs of le deformation (15). The presence of a retained
instrument fragment within the root canal systemalone is an insufcient
predictor of treatment outcome success. However, if the canal
harboring the instrument fragment was insufciently cleaned before
separation and infective microorganisms remain within the canal, the
prognosis may be less favorable (16, 17).
The concept of shaping a canal with an engine-driven recipro-
cating instrument in an asymmetric envelope of motion is relatively
new. The incidence of instrument separation associated with this tech-
nique should be studied in a clinical environment. Posterior teeth are
the most appropriate specimens for this study given their challenging
anatomy and the higher likelihood of instrument fracture (18).
The cleaning and shaping protocols reected in this prospective
clinical study were established in accordance with the manufacturers
guidelines in order to standardize the treatment protocol between op-
erators. A reproducible glide path was established either manually or
with the assistance of engine-driven glide path les. The selected
method for glide path preparation was dictated by canal anatomy and
was determined based on the discretion of the treating clinician. In
2012, Alves Vde et al (19) found no signicant clinical difference in api-
cal transportation when comparing the use of hand les with engine-
driven glide path les used in the creation of a glide path. De-Deus
et al (20) assessed the frequency at which reciprocating les were
able to achieve the full working length in mandibular molar canals
without a reproducible glide path. De-Deus et al concluded that these
les were able to achieve the full working length only when the canal
was straight or moderately curved.
Three instrument separations occurred over the course of this
study, yielding a separation incidence of 0.13% in relation to the num-
ber of canals and 0.42% according to the number of teeth treated.
Several studies currently exist looking at the separation incidence of ro-
tary instruments during root canal treatment (814, 18, 21). In all of
these studies, the le separation incidence was found to be higher
when compared with the results of the current study. Separation
incidence ranged from 0.3% in Shen et als study (13) to 2.6% in
Wu et als study (10).
A possible explanation as to why the separation incidence
observed in the current study is lower than those reported in the afore-
mentioned studies could relate to clinician skill level. Experience level
ranged from undergraduate students (12, 13) to postgraduate students
(14, 18, 21) and endodontic specialists (8, 9, 11) in the series of
studies, whereas the current study observed treatments performed
exclusively by endodontic specialists. When comparing the results of
this study with only those studies in which treatment was limited to
endodontic specialists (8, 9, 11), the results suggest a lower
separation incidence with the WaveOne reciprocation system as
opposed to rotary les systems in the hands of specialists.
Within the parameters of this study, all 3 le separations occurred
in the apical portion of the root canal system. This nding was in line
with previous studies that suggested le fractures are more prone to
occur in the apical third of the canal. This is most likely because of
the high anatomic complexity encountered in this region (16, 21).
Two of the 3 separations occurred when using the WaveOne small
les. These les may be at a higher risk for separation given that they
TABLE 1. Data Collected from All Patients Treated between January 2012 and
August 2013
Premolars Molars
No. of
teeth
No. of root
canals
No. of
teeth
No. of root
canals
Maxillary 102 177 293 1,042
Mandibular 42 53 274 943
TABLE 2. Number of Separations with Respect to Tooth Type, Canal, and
Location within the Canal
File
Number of le
separations Tooth Canal Canal location
Small 02 5/3 P/MB Apical/apical
Primary 01 15 DB Apical
Large 00
DB, distobuccal; MB, mesiobuccal; P, palatal.
Clinical Research
JOE Volume 40, Number 7, July 2014 Separation Incidence of WaveOne Files 923
are selected to work in the most challenging canals, namely those with
extreme curvatures or tight constrictions.
The authors have identied 3 potential explanations for the low
incidence of le separation when using reciprocating les. WaveOne
les are manufactured from M-Wire NiTi. Studies have shown that
NiTi les made from M-Wire have both physical and mechanical prop-
erties that increase exibility and improve resistance to cyclic fatigue
compared with les made from conventionally processed NiTi wires
(2226). Therefore, it is conceivable that the metallurgy of the
WaveOne le contributed to its low fracture incidence.
These reciprocating les shape canals using an asymmetric mo-
tion. The le continually changes direction applying greater rotation
in the cutting direction (170

) and less in the reverse direction

(50

) (27). Recent studies suggest that reciprocating movements pro-

long le fatigue and therefore extend the life of engine-driven NiTi in-
struments when shaping curved canals (2830).
The WaveOne systemdoes not allowfor le sterilization; therefore,
each le is considered a single-use instrument. Multiple-instrument us-
age has been shown to signicantly increase the le separation potential
(31) because of a reduction in cyclic exural fatigue resistance. In addi-
tion, as les are reused, they undergo increased wear and develop sur-
face defect that can promote fracture propagation (32). All of the
referenced articles that analyzed clinical le separation presented in
this study (814, 18, 21) used the same instrument(s) multiple
times. Ramirez-Solomon et al (1997) (8) states excessive usage of
the instruments before le separation, and this could explain the higher
incidence of separation when compared to the current study.
It can be concluded that the lowincidence of WaveOne le fracture
seen in the current study may be a direct result of the les metallurgic
composition, reciprocating motion, and/or its single-use nature. Within
the limitations of this study, the incidence of endodontic instrument sep-
aration when using the WaveOne reciprocating le was determined to be
considerably low. Further research should be conducted to corrobo-
rate the ndings of this study.
Acknowledgments
Dr Nudera is an advocate and key opinion leader for Dentsply
Tulsa Dental Specialties.
The authors deny any conicts of interest related to this study.
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Clinical Research
924 Cunha et al. JOE Volume 40, Number 7, July 2014