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Manual versus rotary instrumentation for primary molar pulpectomies- A 24

months randomized clinical trial

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DOI: 10.1016/j.pdj.2018.02.002

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Pediatric Dental Journal

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Research Paper

Manual versus rotary instrumentation for primary

molar pulpectomies- A 24 months randomized
clinical trial

R. Morankar a,*, A. Goyal a, K. Gauba b, A. Kapur a, S.K. Bhatia a

a
Unit of Pedodontics and Preventive Dentistry, Oral Health Sciences Centre, PGIMER, Chandigarh, India
b
Oral Health Sciences Centre, PGIMER, Chandigarh, India

article info abstract

Article history: Objective: The study compared manual and rotary canal instrumentation differences in
Received 26 November 2017 primary molars receiving pulpectomy and their effect on clinical success after two years.
Received in revised form Materials and methods: Sixty pulpally involved primary mandibular second molars requiring
3 January 2018 pulpectomy treatment were randomly assigned for manual or rotary instrumentation in
Accepted 19 February 2018 children aged 4e7 years. The endodontic procedural steps were similar except the method
Available online xxx of root canal instrumentation i.e. manual group (Stainless steel files 2% taper) and rotary
group (Hyflex CM NiTi rotary files 4% taper).
Keywords: Results: The mean instrumentation time for the manual and rotary groups were 25.71 ± 3.84
Rotary instrumentation and 19.37 ± 4.94 min respectively with a statistically significant difference (p < 0.001) be-
Manual instrumentation tween the groups. The differences between the groups' obturation time, quality of obtu-
Primary molars ration, and complications during instrumentation were not statistically significant
(p > 0.05). At 24 months, the clinical success was 92.3% and 85.2% (p ¼ 0.52) whereas the
radiographic success was 65.4% and 66.7% (p ¼ 0.78) comparing the manual and rotary
groups respectively.
Conclusion: Rotary instrumentation takes significantly less time than manual. There was no
difference in obturation time, quality of obturation, or success rates after 24 months.
© 2018 Japanese Society of Pediatric Dentistry. Published by Elsevier Ltd. All rights reserved.

loss of primary teeth still remains a common problem.

1. Introduction
Despite the emphasis on prevention, damage to dental pulp
still occurs. This can be from the progression of dental caries,
restorative procedures, or traumatic injuries [1]. Premature
Retaining pulpally involved primary teeth preserves arch
space which decreases aberrant tongue habits, maintains es-
thetics, and helps in normal eruption of succedaneous teeth
[2]. One of the treatment options for pulpally affected primary
molars is pulpectomy, which has several advantages over

* Corresponding author. Room.no 202, Unit of pedodontics and preventive dentistry, Oral Health Sciences Centre, PGIMER, Chandigarh,
160012, India.
E-mail addresses: captainrahul88@gmail.com (R. Morankar), ashimapgi@yahoo.in (A. Goyal), gaubakrishan@gmail.com (K. Gauba),
draditikmalhotra@yahoo.com (A. Kapur), docsarab2005@rediffmail.com (S.K. Bhatia).
https://doi.org/10.1016/j.pdj.2018.02.002
0917-2394/© 2018 Japanese Society of Pediatric Dentistry. Published by Elsevier Ltd. All rights reserved.

Please cite this article in press as: Morankar R, et al., Manual versus rotary instrumentation for primary molar pulpectomies- A 24
months randomized clinical trial, Pediatric Dental Journal (2018), https://doi.org/10.1016/j.pdj.2018.02.002
2 p e d i a t r i c d e n t a l j o u r n a l x x x ( 2 0 1 8 ) 1 e7
extraction. The procedure includes removal of irreversibly
inflamed or necrotic radicular pulp tissue, cleaning the root
canal system, followed by root canal filling. The success of
pulpectomy treatment depends on the method and the qual-
ity of instrumentation, irrigation, disinfection and obturation
of the root canals [3,4].
Instrumentation of root canals in primary teeth is carried
out with the primary objective to remove the infection [5]. It is
challenging due to the presence of extensive webbing of
pulpal tissue within the narrow and curved roots of primary
teeth which exhibit continuous physiological resorption
[6].The traditional method of cleaning and shaping the root
canals in permanent teeth using manual stainless steel files
can lead to undesirable curvatures in root canal morphology
making a proper filling of the root canals difficult. It is also
time-consuming and sometimes leads to iatrogenic errors [7].
Rotary nickel-titanium instrumentation techniques have been
developed to overcome these problems. Several investigators
have reported the superiority of rotary instrumentation over
manual in permanent teeth [8]. However, there is a paucity of
literature regarding the use of rotary instruments in primary
teeth. Some in-vitro studies have demonstrated the superi-
ority of nickel titanium rotary instruments over the manual
one with regard to time efficiency and cleaning capacity for
instrumentation of root canals in primary teeth [9e15].
There are no published papers on primary tooth pulpec-
tomy comparing different instrumentation methods and their
effect on success after two years. The majority of the trials are
either in-vitro or are cross-sectional in design [9e16]. The
purpose of this investigation in primary teeth was two-fold: (1)
to evaluate if there was any difference between manual and
rotary canal instrumentation time, obturation time, quality of
fill and complications during instrumentation; (2) to compare
the clinical and radiographic pulpectomy success when using
hand files versus rotary files after two years.
2. Materials and methods
2.1. Sample selection
Based on history, clinical signs and symptoms and radio-
graphic examination a total of 60 decayed primary mandib-
ular second molars, requiring pulpectomy treatment were
selected from children aged 4e7 years, attending the Outpa-
tient Unit of Pediatric and Preventive Dentistry at Oral Health
Sciences Centre, Postgraduate Institute of Medical Education
and Research, Chandigarh. Inclusion criteria for the sample
were teeth that exhibited any one or more of the following: a
necrotic pulp, sinus tract, irreversible pulpitis symptoms,
radiolucent areas in furcation or periapical region, and had at
least two-thirds of each root remaining. Exclusion criteria
were teeth with any of the following associated characteris-
tics: tooth structure inadequate for restoration, perforated
pulpal floor, swelling (intraoral or extraoral) and excessive
mobility. In addition, children with mental disabilities, sys-
temic diseases, and those requiring sedation/general anes-
thesia for management were not included in the study.
An ethical clearance was obtained from Institute Ethic
Committee before the commencement of the study. The
Please cite this article in press as: Morankar R, et al., Manual versus rotary instrumentation for primary molar pulpectomies- A 24
months randomized clinical trial, Pediatric Dental Journal (2018), https://doi.org/10.1016/j.pdj.2018.02.002
parents were informed about the objectives of the study and a
written informed consent was obtained.
2.2. Randomization
The selected mandibular second primary molars were
randomly allocated to one of the two treatment groups using
block randomization technique of varying block sizes using
computer generated sequence. It was provided by an inde-
pendent researcher not involved in the study. The allocation
was done using serially numbered concealed envelopes
opened just after working length determination by a person
other than the operator. Block randomization ensures equal
chance of selection without any allocation bias also the
sample remain equally distributed at any given point of time.
2.3. Clinical procedure
The pulpectomy procedure was performed on all the selected
teeth in a single appointment by the same operator (Principal
Investigator). Routine non-pharmacological behavior man-
agement techniques were used to manage the children. The
standard endodontic procedural steps were performed on all
the selected teeth. The intervention (rotary group) and control
(manual group) differed only in terms of root canal instru-
mentation technique. The clinical procedural steps included;
administration of local anesthesia (2% lignocaine, Lignox,
Bangalore, India), application of rubber dam and adequate
root canal access preparation. The pulpal debris was removed
with broaches and canals were irrigated with 2.5% sodium
hypochlorite (Alfa Laboratories, India). No. 15 fine reamers
and files (Mani Inc. Japan) were gently inserted into the canals
and a diagnostic radiograph was obtained to establish the
length of root canals. In the manual group, instrumentation of
the root canals was done using manual stainless steel files
(No.15e30 files with 2% taper Mani Inc. Japan) in a sequential
manner to the predetermined working length. Copious irri-
gation was done using 2.5% sodium hypochlorite and normal
saline alternatively. All the canals were enlarged up to a size of
No. 30 file. In the rotary group, instrumentation of the root
canals was done using hyflex-CM [17e19] nickel titanium ro-

ne Whaldent Inc., USA) with 4% taper operating
tary files (Colte
at 500 rpm with minimum torque setting. After establishing
the working length, an orifice opener (08/25,19 mm) of 8%
taper, size 25, length 19 mm was used in the coronal root canal
up to 3e4 mm using a crown-down method to widen the canal
orifice. Further, cleaning and shaping of the root canals was
carried out using rotary files nos. 04/20, 04/25, 04/30 in a
sequential manner to the predetermined working length. Care
was taken to avoid any over instrumentation. Copious irriga-
tion was done using 2.5% sodium hypochlorite and normal
saline alternatively. All the canals were enlarged up to a size of
No.30 file.
The prepared canals were dried with absorbent paper
points (SSWhite, Lakewood, New Jersey) followed by obtura-
tion with a mixture of calcium hydroxide paste (Apexcal,
Ivoclar Vivadent, USA) and zinc oxide powder (Septodont,
India). The obturation mixture was prepared by mixing a
7.5 cm long strip of calcium hydroxide paste (Apexcal, Ivoclar
Vivadent, USA), 70 mg of Zinc oxide powder (Septodont, India)
 p e d i a t r i c d e n t a l j o u r n a l x x x ( 2 0 1 8 ) 1 e7
[pre-weighed capsule] and a few drops of normal saline to
obtain the desired consistency [20,21]. The mixture was car-
ried inside the root canals with an engine driven lentulo spiral
in a clockwise motion. The pulp chamber was cleaned with a
moist cotton pellet followed by restoration with glass ionomer
cement (GC Gold Label Universal Restorative, Japan). Radio-
graphic assessment regarding the quality of root filling was
done immediately post-obturation by an independent cali-
brated evaluator using the modified Coll and Sadrian criteria
[22]. The root filling terminating at or within 2 mm from
radiographic apex was considered optimum. Instrumentation
and obturation times were calculated by one of the evaluators
using a stopwatch.Instrumentation time was the time
required to negotiate and shape the root canals to the desired
size after root canal access opening and working length
determination. Obturation time was the time required to
obturate all the root canals of a tooth after instrumentation.
Stainless steel crowns (3M, ESPE,USA) were placed as a final
restoration in all the pulpectomized teeth to prevent restora-
tion fracture and microleakage. The crowns were placed in the
second appointment scheduled within seven days post-
obturation as some younger children could not bear the long
appointments. Thus, in order to have a standardized proced-
ure all the crowns were placed in the second visit in all the
children.
2.4. Follow-up evaluations
Pulpectomized teeth were evaluated clinically and radio-
graphically at 3, 6 and 24 months post-operatively using the
modified Coll and Sadrian criteria by independent calibrated
evaluators who were blinded to the instrumentation tech-
nique used [22]. The pulpectomy treatment was judged as
clinically successful if there was none of the following: history
of pain, tenderness to percussion, gingival swelling, sinus
tract formation, or abnormal tooth mobility. Similarly, a pul-
pectomy was judged radiographically successful if there was
none of the following: increase in the size of pre-operative
radiolucency, development of new radiolucency on subse-
quent follow-ups and development of pathologic root
resorption (internal or external). The radiographs were coded
and shuffled before evaluations for the purpose of blinding.
The clinical and radiographic success was determined inde-
pendently as all radiographic failures were not associated
with clinical symptoms and vice versa.
2.5. Statistical analysis
The quantitative and qualitative data were analyzed statisti-
cally using Student t-test, chi-square, and Fisher's exact tests
where indicated. All statistical tests were two-sided and per-
formed at a significance level of p ¼ 0.05.
3. Results
The mean age of the children included in the manual and
rotary instrumentation technique groups were 5.57 ± 0.817
and 5.57 ± 0.774 respectively (p ¼ 1.00). The manual group
Please cite this article in press as: Morankar R, et al., Manual versus rotary instrumentation for primary molar pulpectomies- A 24
months randomized clinical trial, Pediatric Dental Journal (2018), https://doi.org/10.1016/j.pdj.2018.02.002
3
numbered 15 males and 15 females while the rotary group had
17 males and 13 females (p ¼ 0.60).
3.1 The mean instrumentation time (in minutes) for the
manual group was 25.71 ± 3.84 versus the rotary group
time of 19.37 ± 4.94 (p < 0.001). The mean obturation
time (in minutes) was 5.23 ± 0.91 for manual instru-
mentation compared to 4.72 ± 0.99 for rotary (p ¼ 0.07)
(Table 1).
3.2 The quality of obturation in the 60 roots in the manual
and rotary groups did not differ significantly (p ¼ 0.40)
(Table 2). Instrument fracture occurred in two (6.7%)
cases during rotary instrumentation and in none during
manual instrumentation with the difference being sta-
tistically non-significant (p ¼ 0.49).
3.3 The intergroup comparison of clinical, radiographic
success did not reveal any statistically significant dif-
ference between the two study groups at 3, 6, or 24
months. At 24 months, the clinical success was 92.3%
and 85.2% (p ¼ 0.52) and the radiographic success was
65.4% and 66.7% (p ¼ 0.78) with the manual and rotary
techniques of root canal instrumentation respectively
(Table 3).
There were two dropouts in the manual group and one in
the rotary group over 24-months. One in each group did not
return for the 3 month appointment and the other from the
manual group for the 24-month follow-up. Four teeth had
exfoliated (two each in the manual and rotary group) 6 months
after pulpectomy. These teeth were asymptomatic until ex-
foliations and thus were not considered as a failure. They
were excluded from further evaluations. Early exfoliations
cannot be correlated with preoperative radiographic status as
only one of these four teeth had radiolucency at baseline.
Three teeth were clinically symptomatic immediately after
pulpectomy.They were retreated and recorded as a clinical as
well as radiographic failure.
4. Discussion
The present randomized controlled clinical trial (RCT) was
planned for comparative evaluation of manual and rotary
techniques of root canal instrumentation in primary molars.
A significant reduction in instrumentation time for pri-
mary molars was found in the present study with the rotary
technique. This finding is consistent with the results of
Romero et al., 2011 [16] and Makarem et al., 2014 [23] who too
reported a significant decrease in mean instrumentation time
Table 1 e Comparison of instrumentation and obturation
time (minutes) for two study groups.
Evaluation Instrumentation Mean time ± SD P
parameter technique (minutes) value
Instrumentation Manual 25.71 ± 3.84 <0.001
time Rotary 19.37 ± 4.94
Obturation time Manual 5.23 ± 0.91 0.07
Rotary 4.72 ± 0.99
4 p e d i a t r i c d e n t a l j o u r n a l x x x ( 2 0 1 8 ) 1 e7

Table 2 e Quality of obturation in the two study groups.

Quality of obturation Study groups P value
Manual group Rotary group Total
(N ¼ 60 roots) (N ¼ 60 roots) (N ¼ 120 roots)
N % N % N %
Optimum filled 41 68.3% 37 61.7% 78 65.0% 0.40
Over filled 10 16.7% 16 26.7% 26 21.7%
Under filled 9 15.0% 7 11.7% 16 13.3%
Total 60 100% 60 100% 120 100%

Table 3 e Clinical and radiographic success of pulpectomy with manual and rotary instrumentation techniques.
Evaluation criteria Manual group Rotary group P value Total
N % N % N %
a,b,c
Clinical Success 3 months (N ¼ 58) 28/29 96.6% 27/29 93.1% 0.55 55/58 94.8%
6 months (N ¼ 58) 28/29 96.6% 27/29 93.1% 0.55 55/58 94.8%
24 months (N ¼ 53) 24/26 92.3% 23/27 85.2% 0.41 47/53 88.7%
Radiographic Successa,b,c 3 months (N ¼ 55) 20/29 69.0% 23/29 79.3% 0.22 43/58 74.1%
6 months (N ¼ 55) 21/29 72.4% 19/29 65.5% 0.70 40/58 68.9%
24 months (N ¼ 50) 17/26 65.4% 18/27 66.7% 0.75 35/53 66.0%
a
Three dropouts (two from manual group and one from rotary group) one from each group lost before 3 months and one from group manual
not reported for 24 months follow up.
b
Four teeth exfoliated (two from manual group and two from rotary group) after 6 months were excluded from further evaluations.
c
Three teeth failed (one from manual group and two from rotary group) immediately after pulpectomy were recorded as clinical as well as
radiographic failure.

in primary molars using rotary technique compared to
manual. A decreased instrumentation time reduces the pa-
tient's and dentist's fatigue, thereby allowing a faster, safer
and quality procedure. On the contrary, Madan et al., 2011 [13]
demonstrated an increased instrumentation time in primary
teeth on comparing rotary profiles to manual K-files. Accord-
ing to the authors themselves, this could be attributed to the
operator's experience and number of files used during rotary
instrumentation. Although, in the present study rotary tech-
nique took significantly less time for instrumentation in pri-
mary molars compared to manual technique, it was relatively
longer (mean 19.37 ± 4.94 min) than the instrumentation time
reported by Kuo et al., 2006 [24] (4e5 min) and Romero et al.,
2011 [19] (mean 13.3 min).This can be attributed to the number
of rotary files (08/25, 04/20, 04/25, 04/30) used in present study
leading to sequential enlargement of root canal in comparison
to other studies which used less numbers of rotary files
without any instrument sequence.
The manual and rotary instrumentation techniques
showed an equal performance in terms of quality of fill in the
present study. This finding was in contradiction to studies by
Romero et al., 2011 [16] and Makarem et al., 2014 [23] who in
their studies found a better quality of obturations with the
rotary instrumentation technique compared to manual. The
authors proposed that the rotary instrumentation technique
prepares conical canals which results in better quality obtu-
rations compared to manual technique which resulted in
irregularly shaped canals [10,16,23,25]. The equal performance
shown by rotary and manual techniques of instrumentation
in terms of quality of root filling can be attributed to the same
filling method used in the present study, as all the root canals
were obturated using a low-speed engine driven lentulo spiral.
The present study also investigated different complica-
tions during the instrumentation of the root canals in primary
molars. Instrument fracture was the only complication
noticed. It was observed in two (6.7%) cases in the rotary group
only. Though, this intergroup difference was statistically non-
significant, it bears considerable clinical significance as this
can be a limiting factor for use of rotary instrumentation in
primary teeth. An attempt of instrument retrieval was made
but was unsuccessful. Both the teeth with fractured instru-
ment were obturated and were found to be successful on
clinical and radiographic follow-up evaluations and are under
periodic observation. Operator-related factors such as their
proficiency with the instruments and the decision on the
number of uses after which the instruments have to be
replaced may help to explain the variation in the prevalence of
fractured instruments reported among the different studies
[26]. It is important to know that reasons for fracture of rotary
NiTi instruments are complex and multifactorial [26,27] and
complications related to instrument fracture can be avoided
with better operator skill and experience and by avoiding the
overuse of instrument.
After 24 months, 92.3% teeth in the manual and 85.2% teeth
in the rotary group were clinically asymptomatic (Fig. 1).The
results are consistent with studies by Thomas et al. [28], Reddy
and Fernandes [29], Mani et al. [30], Ozalp et al. [31], and
Chawla et al. [20]. They all reported a high degree of clinical
success for pulpectomy procedures in primary molars using
manual instrumentation ranging between 80 and 100%. Kuo
et al. [24] in their study reported the clinical success of pul-
pectomy in primary molars to be 95% after 12 months using
the rotary method of instrumentation. In the present study,
the radiographic success of pulpectomy after 24 months was

Please cite this article in press as: Morankar R, et al., Manual versus rotary instrumentation for primary molar pulpectomies- A 24
months randomized clinical trial, Pediatric Dental Journal (2018), https://doi.org/10.1016/j.pdj.2018.02.002
 p e d i a t r i c d e n t a l j o u r n a l x x x ( 2 0 1 8 ) 1 e7 5

Fig. 1 e CONSORT design.

Please cite this article in press as: Morankar R, et al., Manual versus rotary instrumentation for primary molar pulpectomies- A 24
months randomized clinical trial, Pediatric Dental Journal (2018), https://doi.org/10.1016/j.pdj.2018.02.002
6 p e d i a t r i c d e n t a l j o u r n a l x x x ( 2 0 1 8 ) 1 e7
65.4% and 66.7% (p ¼ 0.78) and did not differ statistically be-
tween the manual and rotary technique of instrumentation.
Though, this radiographic success was less compared to suc-
cess reported by other studies in the literature, only three
teeth in manual group and five teeth in rotary group required
retreatment. This discrepancy between clinical and radio-
graphic success can be attributed to silent radiographic fail-
ures which occurred in seven teeth treated with the manual
technique and in five teeth treated with rotary technique.
These teeth added to the radiographic failure though they
were clinically asymptomatic.
It is pertinent to mention that besides instrumentation, the
success of pulpectomy also depends on the obturating mate-
rial. A mixture of zinc oxide eugenol and calcium hydroxide
was used as an obturating material in the present study.
Chawla et al., 2008 [20] had used the same obturating material
and reported a clinical success of 96.1% after 12 months. The
radiographic success in the present study with manual and
rotary instrumentation techniques using a mixture of zinc
oxide eugenol and calcium hydroxide for obturation is less
compared to studies by Chawla et al., 2008 [20] and Chawla
et al., 2001 [21]. This to an extent can be attributed to radio-
graphic evaluation criteria. These authors included only
changes in the furcation and periapical areas as a determinant
of radiographic success and not pathological root resorption
thus, leading to more radiographic success in their studies.
Both root resorption and periapical radiolucent defects are the
radiographic expressions of a periapical inflammatory process
and need to be considered in radiographic success.
The introduction of the nickel-titanium rotary system for
the instrumentation of root canals in primary teeth is recent.
There are limited clinical trials comparing manual and rotary
techniques of instrumentation in primary teeth. Studies on
permanent teeth by Pettiete et al., 1999 [32], Marending et al.,
2005 [33], Peters et al., 2004 [34] and Iqbal et al., 2009 [35] had
shown that the type of instrumentation has no significant
effect on the outcome of root canal treatment. Apart from the
method of instrumentation and obturation material the suc-
cess of pulpectomy procedure also depends on the quality of
obturation, irrigation solution and post-obturation restoration
[3,4]. In the present study, the two study groups differed only
in terms of technique of root canal instrumentation while all
other factors were controlled which could be a reason for
nearly similar clinical and radiographic success after 24
months.
5. Conclusions
From the results of the present study it can be concluded that
rotary technique required significantly less time for instru-
mentation of root canals in primary molars compared to
manual. There was no difference in obturation time, quality of
obturation, or clinical and radiographic success rates after 24
months between manual and rotary techniques.
Thus, rotary instrumentation can be used as a suitable
alternative to manual instrumentation in primary teeth. The
results of the present study emphasize the need for further
clinical trials with a larger sample and longer follow-up to
adapt the technique in primary teeth.
Please cite this article in press as: Morankar R, et al., Manual versus rotary instrumentation for primary molar pulpectomies- A 24
months randomized clinical trial, Pediatric Dental Journal (2018), https://doi.org/10.1016/j.pdj.2018.02.002
Conflict of interest
Authors have no conflict of interest to declare.
Author contributions
Goyal A and Gauba K conceived the ideas; Morankar R is the
principal investigator. Kapur A and Bhatia SK collected the
data; Morankar R and Goyal A analyzed the data; All the au-
thors led the writing. All authors have made substantive
contribution to this study and/or manuscript, and all have
reviewed the final paper prior to its submission.
Acknowledgment
None. Research is independent and not funded by any agency.
Appendix A. Supplementary data
Supplementary data related to this article can be found at
https://doi.org/10.1016/j.pdj.2018.02.002.
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Please cite this article in press as: Morankar R, et al., Manual versus rotary instrumentation for primary molar pulpectomies- A 24
months randomized clinical trial, Pediatric Dental Journal (2018), https://doi.org/10.1016/j.pdj.2018.02.002
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