Odontology (2012) 100:130136
DOI 10.1007/s10266-012-0066-1
REVIEW ARTICLE
Impact of nickeltitanium instrumentation of the root canal
on clinical outcomes: a focused review
Edgar Schafer Sebastian Burklein
Received: 17 January 2012 / Accepted: 2 April 2012 / Published online: 22 April 2012
! The Society of The Nippon Dental University 2012
Abstract Nickeltitanium (NiTi) root canal instruments
have improved the technical quality of enlarging and
shaping. These instruments have been shown to prepare
even severely curved root canal with fewer procedural
errors than traditional stainless steel hand instruments.
While it would appear that these instruments might
enhance clinical outcomes, very few studies have assessed
their impact when used in primary root canal treatment.
Clinical studies investigating the outcome of primary root
canal treatment using nickeltitanium hand or rotary
instruments were identified (MEDLINE database) using
appropriate key words in an attempt to determine if there
have been enhanced outcomes with these instruments.
Evidence from one clinical trial suggests that (i) better
maintenance of the original canal curvature and shape
results in increased success rates and (ii) that ledging of
root canals results in reduced success rates. Evidence from
two studies indicates that the use of NiTieither hand or
rotaryinstruments significantly increases success rates of
primary nonsurgical root canal treatment compared with
the use of stainless steel hand instruments, while three
investigations failed to show any significant differences.
Keywords Flare-up ! Periapical health ! Prognosis !
Success rate ! Survival
E. Schafer (&) ! S. Burklein
Central Interdisciplinary Ambulance in the School of Dentistry,
University of Munster, Waldeyerstr. 30,
48149 Munster, Germany
e-mail: eschaef@uni-muenster.de
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Introduction
Numerous, mostly retrospective studies have analyzed data
to identify relevant factors having a certain impact on the
outcome of nonsurgical primary root canal treatment (for an
overview see [1]). Factors that have been identified include
apical extent of root canal filling [2], immune status of the
patient [3], presence of periapical lesion [1, 4], pulpal status
(vital versus non-vital) [5], quality of the coronal restoration
[1], and root filling density [1, 6]. Besides these unambig-
uous factors the effect of other aspects on the success rates of
primary root canal treatment is currently inconclusive. For
instance, regarding the effect of the size of periapical/per-
iradicular lesions some investigations reported reduced
success rates in the case of larger lesions [710], while other
studies failed to confirm this finding [11, 12]. Furthermore,
the impact of the age of the patient on the outcome is
indecisive. Some studies have found that the age has no
significant influence on the success rates [1, 1315], while
another study performing a multivariate analysis of the
outcome of root canal treatment has identified the variable
age to exert a significant impact [6].
The question of whether the general health of the patient
displays a certain effect on the treatment outcome has
become a matter of intensive research. In 1969, Storms [7]
was unable to detect a correlation between the health of the
patient and the treatment outcome, while more recent
studies identified this parameter as having a strong influ-
ence on the success rates of root canal treatment [3, 16, 17].
Systemic diseases like diabetes mellitus, hypertension, and
coronary artery disease are obviously associated with an
increased risk of tooth extraction after nonsurgical root
canal treatment [1618].
Surprisingly few studies have assessed the influence of
specific instruments or preparation techniques on treatment
Odontology (2012) 100:130136 131

Table 1 Clinical studies comparing root canal instrumentation using
NiTi and stainless steel instruments
Authors Instruments Evaluated criteria
Pettiette et al. 1999 Stainless steel hand Canal straightening
[30] K-files
NiTi hand instruments
Schafer et al. 2004 Stainless steel hand Canal straightening
[25] instruments
Rotary NiTi Apical file size
instruments Preparation time
Kleier and Stainless steel hand Number of
Averbach instruments appointments
2006 [24] required
Rotary NiTi Canal shape
instruments Apical file size
outcome [14, 19, 20]. According to Kirkevang and Hor-
sted-Bindslev this lack of evidence can be explained by the
fact that among the aforementioned numerous factors
affecting the outcome it is rather difficult to single out the
effect of a specific instrumentation technique or a specific
type of root canal instrument [21]. Nonetheless, with the
introduction of root canal instruments made from the su-
perelastic alloy nickeltitanium the technical quality of
root canal preparation has been steadily improving during
the past years. Nickeltitanium (NiTi) hand as well as
rotary instruments with tapers greater than the ISO-stan-
dard have been shown in numerous in vitro studies (for
overviews see [22, 23]) and in some clinical studies
(Table 1) to enlarge and shape even severely curved root
canal with fewer procedural errors than traditional stainless
steel hand instruments. These differences in the centering
ability of especially rotary NiTi instruments versus stain-
less steel hand instruments are even more pronounced
when the final apical preparation is larger than size 30.
Thus rotary NiTi instruments offer the opportunity to
enlarge root canals to greater apical preparation sizes [23
27]. When viewed in total, these positive attributes would
tend to support the speculation that the use of NiTi
instrument may very well result in enhanced clinical out-
comes. The aim of this focused review is to assess if evi-
dence from clinical studies is currently available
supporting this speculation.
Literature search
Clinical studies investigating the outcome of primary root
canal treatment using NiTi hand or rotary instruments were
identified electronically (MEDLINE database). Studies
published up to the end of May 2011 were included. The
following key words were used for the search: nickel
titanium; NiTi; root canal preparation; root canal instru-
mentation; root canal treatment; root canal therapy; treat-
ment outcome; success; survival; hand instruments; and
rotary instruments. Besides the MEDLINE search also a
Cochrane Library search was performed. Moreover, the
most relevant endodontic journals (International End-
odontic Journal, Journal of Endodontics, Oral Surgery Oral
Medicine Oral Pathology Oral Radiology and Endodon-
tology, Dental Traumatology, Endodontic Topics) as well
as the reference lists of all relevant articles were hand
searched. Full articles were obtained for all relevant papers.
Considered outcome measures
Outcome measures of root canal treatment have included
among other things inter-appointment pain/swelling, reso-
lution of pain, healing of apical periodontitis, tooth sur-
vival, procedural errors, and reduction of root canal
bacterial load. This focused-review considered studies
evaluating success based on healing of apical/periradicular
periodontitis, respectively, with periapical health following
primary nonsurgical root canal treatment as the main out-
come measure. Additionally, two further surrogate out-
comes were considered, namely tooth survival and
interappointment flare-ups. The criterion tooth survival
was selected since recently the American Association of
Endodontists adopted revised definitions of success fol-
lowing root canal treatment that included tooth survival as
an outcome measure [28]. The outcome measure flare-
up was included since it has recently been shown that
absence of interappointment flare-ups significantly
improves periapical healing [29]. Details of the included
studies are summarized in Table 2. Studies with other
surrogate outcomes were not taken into consideration since
the influence of other measures on periapical health of root
canal-treated teeth is currently inconclusive [1].
Comparison of stainless steel and NiTi hand
instruments
Only one study (out of 327 publications) was identified
comparing stainless steel hand instruments with manual
NiTi instruments. This prospective cross-over designed
investigation evaluated root canal treatment performed by
undergraduate students [30, 31]: In the first part of this two-
part clinical trial, 60 molar teeth were treated by inexpe-
rienced dental students and root canal transportation and
procedural errors of the root canal treatment were evalu-
ated [30]. Root canal instrumentation was performed with
0.02 tapered hand NiTi instruments or with ISO sized
stainless steel hand K-files. All root canals were enlarged

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132 Odontology (2012) 100:130136

Table 2 Profile of the included studies

Study Outcome Type of study Evidence Number Follow-up Recall Instruments Outcome
measure levela of cases rate used

Pettiette Periapical Prospective 2b 60 molars 1 year 66 % SS K-files Significant better success

et al. health cross-over rates for teeth instrumented
1999 [30] with NiTi instruments
Pettiette NiTi hand
et al. instruments
2001 [31]
Marending Periapical Prospective 2b 132 teeth; C30 months 79 % SS K-files Type of instrumentation had
et al. health observational 84 (mean: NiTi rotary no significant effect on
2005 [3] patients 46 months) treatment outcome
Cheung Periapical Retrospective 2b 225 Mean: SS K-file 3.8-fold higher success when
and Liu health cohort study molars; 31.6 months NiTi rotary using NiTi rotary
2009 [35] 216 instruments compared with
patients SS K-files
Peters et al. Periapical Retrospective 2b 268 teeth; Mean: 88.6 % Different NiTi Preparation technique had no
2004 [36] health cohort study 179 25.4 months rotaries effect on healing rates
patients
Iqbal et al. Incidence Retrospective 2b 6580 N.A. SS hand Type of instrumentation had
2009 [33] of flare- patients instruments no significant effect on the
up NiTi rotaries incidence of flare-ups
Fleming Tooth Retrospective 2b 984 teeth; Mean: SS hand No significant differences
et al. survival 857 75.7 months Combination of between the groups
2010 [34] patients NiTi rotary
and SS hand
files
a
For definition of the different levels of evidence see Table 3

Table 3 Description of the different levels of evidence as proposed NiTi hand instruments resulted in significantly (P \ 0.001)
by the Oxford Center for Evidence-based Medicine (taken from [37]) less canal straightening and procedural errors such as strip
Level of Description perforations only occurred in teeth instrumented with
evidence stainless steel instruments.
1a: Systematic reviews (with homogeneity) of In the second part of this investigation, the 1-year success
randomized controlled trials rates of the same teeth used in the aforementioned study
1b: Individual randomized controlled trials (with narrow were compared [31]. The recall rate was 66 % (40 out of 60
confidence interval) teeth) and the follow-up cases comprised 19 teeth instru-
1c: All or none randomized controlled trials mented with NiTi and 21 instrumented with stainless steel
2a: Systematic reviews (with homogeneity) of cohort hand instruments. Using customized bit blocks standardized
studies pairs of radiographs (immediate post-operative = first study
2b: Individual cohort study or low-quality randomized and 1-year post-operative recall = second study) were
controlled trials (e.g. \80 % follow-up)
assessed. The comparison of success rates was based pri-
2c: Outcomes Research
marily on the interpretation of the periapical status of the
3a: Systematic review (with homogeneity) of case teeth. Statistical analysis revealed that the operator (student)
control studies
did not have a significant effect on the success rate
3b: Individual casecontrol study
(P \ 0.76), whereas significantly better success rates were
4: Case-series (and poor-quality cohort and case
control studies) observed for teeth prepared with NiTi instruments than with
5: Expert opinion without explicit critical appraisal, or stainless steel K-files (P \ 0.03). The data indicated that
based on physiology, bench research or first maintaining the original canal shape and curvature after
principles instrumentation resulted in increased success rates and thus
better prognosis.
according to the step-back technique. Root canal straight- Nevertheless, this conclusion cannot be directly
ening was defined as the difference between pre-operative extrapolated to all manual instrumentation techniques and
and post-operative canal curvature. Instrumentation using all varieties of hand instruments, as already stated by the

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Odontology (2012) 100:130136
authors [31]. Furthermore, the follow-up period of this trial
was only 1 year and the number of teeth that were subse-
quently evaluated, although statistically significant differ-
ences were obtained, was comparatively small. In addition,
only those cases with stainless steel instruments that had
severe preparation errors, such as perforations, contributed
to the inferior success.
Comparison of rotary NiTi instruments and stainless
steel hand instruments
Four clinical studies (out of 327 publications) were inden-
tified comparing the impact of stainless steel hand instru-
mentation and rotary NiTi preparation on the outcome of
root canal treatment. The designs of these investigations
were relatively heterogeneous, which might be an explana-
tion for the fact that results of these trials were contradictory
to a certain extent in as far as three investigations failed to
show any significant differences between these two types of
instruments. In only one study rotary NiTi instrumentation
resulted in significantly better success rates.
The first study evaluated the effect of stainless steel
hand versus NiTi rotary instrumentation on the outcome of
orthograde root canal therapy [3]. Additional explanatory
variables assessed in this study were patient age, integrity
of the nonspecific immune system, smoking status, PAI
(PERIAPICAL INDEX) score before treatment, initial
versus retreatment, prior exposition of the root canal to
saliva, and quality of the root canal filling. One operator
performed 132 orthograde root canal treatments (42 inci-
sors, 17 canines, 41 premolars, 32 molars) in 84 patients.
The unit of observation was the patient-individual. The
diagnoses of the 84 teeth included in this study were 20
pulpitis, 5 vital, root canal treatment for prosthetic reasons,
32 with necrotic pulps and periapical lesions, 11 non-sen-
sitive teeth, root canal treatment for prosthetic reasons, 11
retreatment with periapical lesion, and 5 retreatment
without periapical lesion. Follow-ups were performed after
a minimum of 30 months, with a mean of 46 12 months.
Periapical health was evaluated radiographically on the
basis of the PAI system [32]. Root canal instrumentation
was performed using either stainless steel K-files used
according to the step-back technique or rotary NiTi ProFile
(Dentsply Maillefer) 0.04 and 0.06 instruments according
to the crown-down approach. The choice of instrumenta-
tion technique was not randomized.
The recall rate was 79 % (66 patients out of 84) and the
distribution of variables evaluated in this study was sta-
tistically similar comparing those patients who failed to
return (drop outs) and patients available for recall. Twenty-
four teeth were shaped and enlarged with rotary NiTi
instruments with 2 drop outs and 58 with hand instruments
133
and 14 drop outs. According to the results, the type of
instrumentation had no significant effect on the treatment
outcome (P = 0.57), whereas the immune status of the
patient, the initial PAI score, and the radiological quality of
the root canal filling were found to have a large influence
on outcomes.
Although the second study did not directly evaluate the
impact of different types of instrumentation on the treat-
ment outcomes of orthograde root canal treatment [33], it
was still considered for this review because it has recently
been shown that absence of interappointment flare-ups
significantly improved periapical healing [29]. In this ret-
rospective investigation the authors assessed different
factors related to flare-ups in nonsurgical root canal treat-
ments performed by graduate students. The records of 6580
patients treated over a period of 5 years were checked
regarding the incidence of flare-ups. This retrospective
analysis of the data revealed a total of 26 patients (0.39 %)
with flare-ups. A logistic regression model was used to
evaluate the following independent variables: history of
previous pain, one versus two visit treatment, periapical
diagnosis, tooth type, lateral versus vertical compaction of
gutta-percha, and hand stainless steel versus rotary NiTi
instrumentation. Both instrumentation strategies were used
according to crown-down technique. No further specifica-
tion regarding the exact types of instruments used are given
in the paper.
Out of the 6580 patients included in this study, 5508
were root canal treated using NiTi rotary instruments with
22 flare-ups (0.40 %) and 1043 with stainless steel hand
instruments with 4 flare-ups (0.38 %), respectively. The
type of instrumentation was found not to exert a significant
influence on the incidence of flare-ups in this study. The
only variables that showed a statistically significant cor-
relation with flare-ups were the presence or absence of
periapical radiolucency and the number of treatment visits.
The probability of developing a flare-up was 9.64 times
greater in teeth associated with a periapical radiolucency
compared with teeth without periapical radiolucency and
was about 40 times greater in cases completed in three or
more appointments than in cases treated in one visit.
The third study evaluated survival rates instead of
classical success rates. Two different treatment groups
were created [34]: the classic group including the use of
stainless steel hand instruments and the contemporary
group using a combination of hand and rotary NiTi
instruments. Nine hundred eighty-four teeth in 857 patients
were root canal treated, 459 in the classic and 525 in the
contemporary group. Survival was defined as radio-
graphic evidence of the treated tooth being present in the
oral cavity. Average follow-up times ranged from 34 to
75.7 months. According to the results, survival rate was
98 % in the classic and 96 % in the contemporary
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group, with no statistically significant difference between
the two treatment groups. However, more teeth in the
classic group required post-treatment interventions (such
as apical surgery, retreatment, and hemisection) than in the
contemporary group (6.7 vs. 0.9 %, respectively).
The informative value of this clinical trial is consider-
ably limited due to many constrains. Being a retrospective
study it mainly evaluated the influence of two different
treatment strategies with marked differences between the
groups. For instance, in the classic group (stainless steel
hand instruments) root canals were irrigated with NaOCl
and H2O2 and obturated using cold lateral compaction.
Second, more contemporary irrigation and obturation
techniques were used in the contemporary group
(chlorhexidine and EDTA irrigation, warm vertical com-
paction). Third, the armamentarium in the latter group
included the use of dental microscopes, ultrasonic instru-
mentation, and electronic apex locators. Thus, it is ques-
tionably if the study designs allowed for identifying the
sole effect of the type of instruments used on the treatment
outcomes. Furthermore, the survival rates were calculated
instead of more relevant success rates. Moreover, while all
teeth belonging to the classic group were treated by only
one operator, those belonging to the contemporary group
were treated by several endodontists. Due to the small
number of operators, the study failed to evaluate if dif-
ferences in the survival rates were caused by differences in
the treatment technique or by the clinical abilities of the
operators. A further aspect that should not be neglected is
the fact that follow-up times were markedly different.
While the mean follow-up time was 75.7 months in the
classic group, only an average follow-up time of
34 months was obtained for the contemporary group. On
the whole, due to these limitations of the study design it
remains questionable if the results provide any evidence
whether the use of different root canal instruments has an
influence on the outcome of nonsurgical root canal
treatment.
In the fourth clinical trial, solely the influence of rotary
NiTi and stainless steel hand instrumentation on treatment
outcome was evaluated [35]. In this retrospective cohort
study a total of 225 maxillary and mandibular first and
second molars, all of them treated by undergraduate or
postgraduate students, in 216 patients were included. Re-
treatments were excluded from this study, and thus only
primary root canal treatment was evaluated. Root canals
were prepared using either stainless steel hand instruments
(Flexofile, Dentsply Maillefer) used in a filing motion or
with rotary NiTi instruments (ProFile .06, Dentsply
Maillefer) used in a hybrid technique based on a combi-
nation of rotary ProFile and NiTi hand instruments. After a
mean of 31.6 22.7 months the patients were recalled for
clinical and radiographic examination. The treatment
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Odontology (2012) 100:130136
outcome was classified into three categories: favorable,
uncertain, and failure to heal. Moreover, five types of
procedural were recorded from the post-obturation radio-
graphs: ledging, lateral or strip perforation, apical trans-
portation, stripping (but not perforated), and instrument
separation.
Root canal preparation with NiTi instruments resulted in
a significantly higher rate of favorable/complete healing
than preparation with stainless steel hand instruments (77
and 60 %, respectively; P \ 0.05). Likewise, significantly
fewer procedural errors were noted when using NiTi
instruments compared with stainless steel hand ones (19.1
and 39.1 %, respectively, P \ 0.05). However, with
respect to procedural errors only the incidence of ledging
and perforation showed significant differences between the
two types of instrumentation. When further analyzing the
influence of procedural errors on the treatment outcome, a
stepwise logistic regression analysis considering ledging
and perforation as variables, while only ledging was
found to have a significant negative impact on the treat-
ment outcome. The odds ratio revealed a twofold higher
chance of failure when ledging occurred during instru-
mentation. In summary, the authors concluded that the
chance of success was about 3.8-fold higher when using
rotary NiTi instruments compared with hand instrumenta-
tion using stainless steel instruments.
Comparison of different rotary NiTi systems
One retrospective study was found comparing the treat-
ment outcome of root canal therapy using three different
types of rotary NiTi instruments [36]. This study included
179 patients and 268 teeth with 661 root canals were
instrumented with three different rotary NiTi systems:
Group A: Lightspeed (Lightspeed Inc. San Antonio, TX,
USA); Group B: ProFile .04 (Dentsply Maillefer, Ballai-
gues, Switzerland; and Group C: either GT Rotary instru-
ments (Dentsply Maillefer) or a combination of ProFile .04
and .06 instruments. All rotary NiTi systems were used in a
kind of crown-down approach. Root canal instrumentation
was performed by two different operators, both having
experience with rotary NiTi root canal preparation for more
than 3 years. All patients were recalled approximately
3 months as well as 1, 2, and 3 years postoperatively.
Teeth were radiographically assessed and the radiographs
were evaluated according to the criteria purported by
rstavik [32]. A periapical index score (PAI) was assigned
to all root apices. The overall recall rate was 88.6 % and
the mean observation time 25.4 11.8 months. Of the
recalled patients, 15.8 % had teeth with an initial diagnosis
of irreversible pulpitis, while all other teeth were diagnosed
as non-vital, including retreatment cases. PAI scores were
Odontology (2012) 100:130136
equally distributed among the three groups (P = 0.434)
and also the recall times were statistically similar among
the groups. Of those recalled, 18.5 % of the teeth were
prepared with instruments of Group A, 38.6 % with
instruments of Group B, and 42.9 % with instruments of
Group C.
Overall, a favorable treatment outcome (defined as
PAI \ 3 at recall) was found in 86.7 % of cases. Univariate
tests and logistic regression analyses showed that the use of
three different rotary NiTi instruments was not associated
with significant differences in radiological treatment out-
comes. Only two pre-operative variables, namely presence
or absence of a periapical lesion and retreatment versus
initial treatment, were found to significantly influence
treatment outcomes. Hence, the selection of different rotary
NiTi instruments used according to the crown-down
approach appeared to have no impact on the treatment
outcome.
Conclusions
Although it is often claimed that root canal preparation
with NiTi instruments results in better maintenance of the
original canal shape and that the use of these modern
instruments has a huge impact on the outcome of root canal
therapy [26, 27], little evidence is currently available
supporting this assumption.
Evidence from one clinical trial suggested that better
maintenance of the original canal curvature and shape
resulted in increased success rates [31]. Level of
evidence: 2b (for definition of the different levels of
evidence see Table 3).
Evidence from one clinical study indicated that ledging
of root canals results in reduced success rates [35].
Level of evidence: 2b (Table 3).
Evidence from two studies suggested that the use of
NiTieither hand or rotaryinstruments significantly
increased success rates of nonsurgical root canal
treatment compared with the use of stainless steel hand
instruments [31, 35]. Level of evidence: 2b (Table 3).
Three investigations failed to show any significant
differences between NiTi and stainless steel instru-
ments [3, 33, 34]. Level of evidence: 2b (Table 3).
Prospectively designed randomized clinical studies
based on the CONSORT agreement and on calculation
of the required number of patients are necessary to
obtain higher levels of evidence, as already demanded
[35, 36]. The suggestion or even recommendation to
use modern NiTi instruments to assure better treatment
outcomes is lacking significantly in evidence-based
support.
135
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