UNIVERSIDADE ESTADUAL PAULISTA
“JÚLIO DE MESQUITA FILHO”
Instituto de Ciência e Tecnologia
Campus de São José dos Campos
ORIGINAL ARTICLE DOI: https://doi.org/10.4322/bds.2025.e4538
1
Braz Dent Sci 2025 Jan/Mar;28 (1): e4538
This is an Open Access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in
any medium, provided the original work is properly cited.
Clinical and radiographic success following pulpectomy of primary
molars with rotary instrumentation versus manual instrumentation:
a 12-month randomized clinical trial
Acompanhamento do sucesso clínico e radiográfico de pulpectomia em molares decíduos com instrumentação rotatória
versus instrumentação manual: um estudo clínico randomizado de 12 meses
Azhar Abdulrahman AL-WESABI1,2 , Kamal El MOTAYAM1 , Ahmed Mohamed Abd ALSAMAD3 , Fatma ABDELGAWAD1
1 - Cairo University, Faculty of Dentistry, Pediatric Dentistry and Dental Public Health Department. Cairo, Egypt.
2 - Hodeidah University, Faculty of Dentistry, Department of Pediatric Dentistry. Hodeidah, Yemen.
3 - Cairo University, Faculty of Dentistry, Oral and Maxillofacial Radiology Department. Cairo, Egypt.
How to cite: Al-Wesabi AA, El Motayam K, Alsamad AMA, Abdelgawad F. Clinical and radiographic success following pulpectomy
of primary molars with rotary instrumentation versus manual instrumentation: a 12-month randomized clinical trial. Braz Dent Sci.
2025;28(1):e4538. https://doi.org/10.4322/bds.2025.e4538
ABSTRACT
Objective: This 12-month randomized clinical trial aimed to estimate the postoperative pain, quality of obturation
and clinical and radiographic success in pulpectomy of primary molars using Fanta baby rotary les versus manual
K-les. Material and Methods: This randomized clinical trial included 46 lower second primary molars in 4-6
years old children. In intervention group, canals were prepared using Fanta baby rotary les, while in control
group, manual K-les were used. The postoperative pain was assessed at 12, 24, 48 and 72 hours using modied
Wong-baker pain scale. Clinical assessment was carried on 1w, 3, 6, 9, 12 months in terms of tenderness to
percussion, mobility, and presence of swelling or stula; while radiographically was on 1 week, 6 and 12 months
using digital imaging technique in terms of size of the radiolucency, no development of new radicular or furcation
radiolucency and no pathologic internal or external resorption. The quality of root canal obturation was assessed
based on the presence of voids and the extent of the lling. Results: At 12 and 48 hours postoperative pain was
signicantly lower in the group prepared with rotary les compared with the manual K-les. At 12 months, the
clinical success was 82.6% and the radiographic success was 78.3% in both groups. No signicant difference
was reported between both groups regarding the presence of voids and the extent of lling (
p
=0.667,
p
=0.261)
respectively. Conclusion: Fanta baby rotary les showed marked reduction in postoperative pain compared to
K- les. Regarding clinical and radiographic success, no signicant differences were observed in both groups in
different follow up intervals. There were no signicant differences in obturation quality after one year.
KEYWORDS
Canal obturation; Deciduous teeth; Digital dental radiography; Metapex; Pulpectomy; Root canal therapy; Root
canal preparation.
RESUMO
Objetivo: este estudo clínico randomizado de doze meses teve como objetivo estimar a dor pós operatória, qualidade
da obturação e sucesso clínico e radiográco de pulpectomias em molares decíduos utilizando a instrumentação de
sistema rotatório Fanta baby em comparação a instrumentação com limas manuais K-les. Material e Métodos:
este estudo clínico randomizado incluiu 46 segundos molares decíduos inferiores de crianças de 4 a 6 anos de
idade. No grupo experimental, os canais radiculares foram preparados utilizando limas rotatórias Fanta Baby,
enquanto no grupo controle, foi utilizado limas manuais k-le. A dor pós operatória foi avaliada após 12, 24,
48 e 72 horas, utilizando-se a escala de dor Wong-baker modicada. A avaliação clínica foi realizada após 1
2
Braz Dent Sci 2025 Jan/Mar;28 (1): e4538
Al-Wesabi AA et al.
Clinical and radiographic success following pulpectomy of primary molars with rotary instrumentation versus manual instrumentation: a 12-month randomized clinical trial
Al-Wesabi AA et al. Clinical and radiographic success following pulpectomy of
primary molars with rotary instrumentation versus manual
instrumentation: a 12-month randomized clinical trial
INTRODUCTION
Worldwide, dental caries is the most
prevalent noncommunicable disease in children.
Progression of caries lesions and dental trauma
can cause pain, infection, swelling and lead to
early tooth loss [1]. Premature loss of primary
teeth leads to serious negative effects (e.g., loss of
space, mesial movement of rst permanent molars,
increased risk of severe crowding, impacted
premolar teeth and psychosocial problems) [2,3].
Therefore, maintenance of primary teeth in the
oral cavity is crucial for a smoother shift from
primary to permanent dentition [4]. Accordingly,
pulpectomy is considered one of the most pivotal
ways of preserving irreversibly inflamed and
necrotic primary teeth [4]. The correct diagnosis,
mechanical root canal preparation and obturation
are predictive factors that have a critical role in
the pulpectomy success [4].
Currently, Biomechanical preparation
performed with manual instrumentation using
stainless steel les is the standard method, despite
its low exibility, undesirable cleaning and shaping
of the canal, potential ledge formation and lateral
perforations, fracture of the instrument and time-
consuming [5]. In addition to these drawbacks, it
causes undesirable impact on the child’s behavior
and cooperation during pulpectomy [5].
To address these challenges, Barr et al. [6]
initiated the use of Ni-Ti rotary les in primary
teeth and reported that it is cost effective, has
greater cutting efficacy in dentin, minimizes
debris extrusion and presents variable tapers to
allow better cleaning with apical control and
obturation with a shorter instrumentation time.
Thereafter, Pinheiro et al. [7] reported that using
rotary instrumentation allows an easier and faster
technique, improves behavior and cooperation
especially for children with behavior management
problems and decreases the professional’s fatigue.
In addition, Topçuoğlu et al. [8] and Nair et al. [9]
proved that their application of rotary les reduced
the intensity and duration of postoperative pain
which is considered unpleasant experiences for
both patients and clinicians.
With the constant progression in the
endodontic field of pediatric dentistry, some
pediatric rotary systems such as Kedo-S (Kedo
Dental, India), PrimeTM Pedo (Sky International
Enterprises, India), DXL-ProTM Pedo (Kraft
marketing, India), Pro AF Baby Gold (Kids-e-
dental, India), Zaunba Kids and AF baby rotary
files (Fanta Dental, Shanghai, China) were
exclusively launched for primary teeth with a
total length of 16-17 mm to improve accessibility
and ease of working.
Despite, several studies [10-12] were
conducted to compare the root canal preparation
using manual les versus rotary, no studies have
investigated the postoperative outcome related to
the application of Fanta baby rotary les. Hence,
we aimed to assess the postoperative pain, quality
of obturation and clinical and radiographic
success associated with Fanta baby rotary les
compared with that of manual instrumentation.
semana, 3, 6, 9 e 12 meses em relação a sensibilidade a percussão, mobilidade e presença de inchaço ou fístula;
já a avaliação radiográca foi realizada após 1 semana, 6 e 12 meses utilizando-se de radiograa digital para
avaliar o tamanho da radioluscência, o não desenvolvimento de nova região radiolúcida na raiz ou furca; e não
ocorrência de reabsorção radicular interna ou externa patológica. A qualidade da obturação do canal foi avaliada
baseada na presença de regiões vazias no conduto e pela extensão do preenchimento. Resultados: após 12 e 48
horas a dor pós operatória era signicativamente menor no grupo que foi utilizado os instrumentos rotatórios
se comparados ao grupo de instrumentação manual. Após 12 meses, o sucesso clínico foi de 82,6% e o sucesso
radiográco foi de 78,3% em ambos os grupos. Não houve diferença signicativa entre os grupos em relação
a espaços vazios e extensão do preenchimento (p= 0.0667; p=0,261) respectivamente. Conclusão: o sistema
rotatório Fanta baby apresentou redução acentuada na dor pós-operatória se comparado a instrumentação manual
k-les. Em relação ao sucesso clínico e radiográco, não foram observadas diferenças signicativas em ambos
os grupos nos diferentes intervalos de acompanhamento. Não houve diferenças signicativas na qualidade da
obturação após um ano.
PALAVRAS-CHAVE
Obturação de canal; Dente decíduo; Radiograa odontológica digital; Mentapex; Pulpectomia; Tratamento de
canal radicular; Preparo de canal radicular.
3
Braz Dent Sci 2025 Jan/Mar;28 (1): e4538
Al-Wesabi AA et al.
Clinical and radiographic success following pulpectomy of primary molars with rotary instrumentation versus manual instrumentation: a 12-month randomized clinical trial
Al-Wesabi AA et al. Clinical and radiographic success following pulpectomy of
primary molars with rotary instrumentation versus manual
instrumentation: a 12-month randomized clinical trial
MATERIAL AND METHODS
Trial design and setting
This randomized clinical trial with two
parallel groups was conducted in the post-
graduate clinic, in Pediatric Dentistry and
Dental Public Health Department - Faculty of
Dentistry. Prior to the beginning of this study,
the research protocol was reviewed and approved
by the Research Ethics Committee, Faculty of
Dentistry, with a number (34-9-19) in relation
to the scientic content and compliance with the
applicable regulations regarding human subjects’
research as well as registered at clinical trial.gov
on 17/07/2019 with identier (NCT03964766).
Selection of participants
Forty-six primary lower second molars in
(36) children between the ages 4 to 6 years
were randomly selected from diagnostic clinic.
Intraoral examinations were performed and
standardized digital periapical radiographs
using X-ray machine (Minray, Soredex, Tuusula,
Finland) were taken for the teeth to determine
whether pulpectomy was indicated. Each tooth
was treated as an independent observation.
Examination
Soft and hard tissue clinical examination
Visual examination was performed to
determine presence or absence of sinus or stula
and presence or absence of swelling, while
palpation of the buccal tissues related to the apex
of the suspected tooth was performed to record
any tenderness and the degree of swelling if
present. The suspected tooth was examined using
a mirror and probe under good lighting conditions
to evaluate the degree of carious involvement and
the amount of remaining tooth structure, also for
presence of pain on percussion. Mobility test used
for the presence or absence of mobility.
Radiographic examination
A preoperative periapical radiograph was
taken using size 1 digital radiographic sensor and
Soredex, x-ray machine with exposure parameters
(70Kvp, 10 mA, and a 0.08 second exposure
time). This was performed to determine the
extent of the carious lesion, the root development,
periapical radiolucency and internal or external
root resorption.
The study’s inclusion and exclusion criteria
Inclusion criteria
• Lower second primary molar requiring
pulpectomy.
• Cooperative children in age range from 4 to
6 years
• Two-thirds of each root remaining.
• No internal or external pathologic root
resorption.
• Presence of adequate coronal tooth structure.
• Healthy children.
• Parent or guardian agree to participate in
the study.
Exclusion criteria
• Tooth with pathologic mobility.
• Children with special health care needs.
Sample size calculation
To obtain a 90% power, and signicant at the
5% level, the primary outcome measure 44% in the
control group and 88% in the intervention group at
12 hours and it was based on Panchal et al. [13].
Thus, the required sample size was 40 primary
molars. The sample size was then increased by
15% to compensate for dropouts to be 46 primary
molars. Sample calculated using G-power*
software version (3.1.9.7) [14].
Participant’s randomization and allocation
Eligible consented participants were randomly
assigned according to a sequence generated on
website [15]. The table of sequence generation
was generated and kept with the assistant
supervisor. The study was explained to the parent/
guardian and a written informed consent was
signed, principal investigator prepared the child
for the procedure after opening the access cavity,
cleaning the pulp chamber, a phone call was
performed to the assistant supervisor to assign
the group according to the sequence generated.
Blinding
Statistician, clinical and radiographic
outcome assessor were blinded to whether it is
an intervention or a control group.
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Braz Dent Sci 2025 Jan/Mar;28 (1): e4538
Al-Wesabi AA et al.
Clinical and radiographic success following pulpectomy of primary molars with rotary instrumentation versus manual instrumentation: a 12-month randomized clinical trial
Al-Wesabi AA et al. Clinical and radiographic success following pulpectomy of
primary molars with rotary instrumentation versus manual
instrumentation: a 12-month randomized clinical trial
Pulpectomy procedures and mechanical
instrumentation
a- Preparation of the tooth for both groups
In all patients, topical anaesthesia (Iolite,
Dharma, USA) was applied, followed by inferior
alveolar nerve block injections with (1 ml) of
Articaine 4% with 1:100,000 epinephrine (Inibsa
Dental S.L.U., Lliçà de Vall, Barcelona, Spain),
then the tooth was isolated with rubber dam.
Dental caries was removed using a high-speed
round bur with copious water spray. An Endo Z
bur (Dentsply, Maillefer, Johnson City, TN) was
used to remove the pulp chamber roof’s and all
of the overlying dentin to create a straight path
into the canals, with removal of coronal pulpal
tissues using excavator and the canal orices were
localized using a DG-16 explorer (Hu-Friedy,
Chicago, IL, USA). Then, each canal’s working
length was determined by inserting 15 K-le 1
mm away from its apex radiographically.
b- Mechanical Preparation
In rotary group (A)
The root canals preparation was performed
by Fanta baby rotary files (FANTATM Dental
Material Co., LTD, China) under 350 rpm speed
and torque of 2N/cm using E connect pro motor
(Hangzhou Eighteeth Medical Technology
Co., Ltd., China). Rotary instrumentation was
preceded by manual instrumentation using no.15
manual Kle in a watch winding motion to full
working length, to scout canal, get a patent
canal pathway and extirpate pulpal tissues.
First, the orifice opener file (17/.08) of 0.08
taper and 0.17 tip was used to prepare 3m of
each canal in brushing motion on the outer wall
and get straight line access [16]. Following that,
canals were prepared with different sizes of les
depending on their width and anatomy [16,17]:
- In narrow and curved canals, preparation
was carried out using 20/04 and 25/04
rotary files in a pecking motion to full
working length.
- For wide and straight canals, preparation
was continued till 30/04 le in a pecking
motion to full working length.
After completion of each le size and at the
end of instrumentation, the canals were irrigated
with 5ml normal saline using disposable syringe.
After each insertion, le was removed and the
utes were cleaned of debris by wiping the le
with alcohol-soaked cotton, file can then be
inserted into canal. EDTA gel (MD-ChelCream,
META BIOMED Co, Ltd., Korea) was used as a
lubricating paste with each rotary le.
In manual group (B)
Pulpal tissues were removed and extirpated
using manual K-le # 15. Using the standardized
technique, root canals were prepared by
sequentially enlarging #15 to #35 K-les with
a quarter-turn-pull motion. The mesiobuccal
and mesiolingual canals were instrumented in
a sequence of size (15/0.02, 20/0.02, 25/0.02
and30/0.02) manual K-les (Mani, Tokyo, Japan)
using a quarter-turn-pull motion to full working
length. While, the wide distal canals were
instrumented using no.20 up to 35 K-les [18].
c- Obturation of the canals and restoration of the
tooth for both groups
Absorbent paper points (size 35 and 40)
were used to dry the canals in preparation for
obturation. Root canals were lled using calcium
hydroxide with iodoform paste (Metapex, Biomed
Co, Ltd., Korea). The metapex syringe was
inserted into the root canal space, to full working
length. The syringe was gradually withdrawn as
paste was pressed into the canals. The access
cavity was sealed using a glass ionomer capsule
(Riva Self Cure GIC, SDI Limited, Australia).
Then, the quality of obturation was checked
by the immediate postoperative radiograph.
Following that, modied Wong-baker pain scale
was provided to the participants’ parents for
the purpose of asking their children about their
postoperative pain levels and indicating the face
that depicted their level of pain at 12, 24, 48 and
72 hours. Each child was provided a prescription
for analgesic (ibuprofen) with instructions to take
only if needed for severe pain after contacting the
investigator, antibiotic was also provided in case
of intraoral swelling postoperatively.
After 5 days from pulpectomy, an
appointment was given to prepare the tooth for
stainless steel crown (Kids Crowns shunghung
Co. Ltd., Korea) that was cemented by glass
ionomer luting cement (Nova G.I.C,Imicryl,
Konya Turkey). The questionnaire was then taken
from the children’s parents/guardians and an
alginate impression was performed to fabricate
acrylic radiographic stent on the cast for each
patient during the second appointment. At 1
5
Braz Dent Sci 2025 Jan/Mar;28 (1): e4538
Al-Wesabi AA et al.
Clinical and radiographic success following pulpectomy of primary molars with rotary instrumentation versus manual instrumentation: a 12-month randomized clinical trial
Al-Wesabi AA et al. Clinical and radiographic success following pulpectomy of
primary molars with rotary instrumentation versus manual
instrumentation: a 12-month randomized clinical trial
week of pulpectomy, standardized postoperative
periapical radiograph was taken using size 1
digital sensor (Digora Optime, Soredex, Tuusula,
Finland) through Soredex x-ray machine (Minray,
Soredex, Tuusula, Finland) with subsequent
exposure parameters: 70kVp, 10Ma and 0.08
seconds exposure time as a baseline record using
acrylic radiographic stent attached to Rinn XCP
(Extension Cone paralleling, Dentsply, United
Kingdom) lm holder and held upright for the
paralleling technique Figure 1.
Outcome assessment
a- Postoperative pain
Intensity of postoperative pain was recorded
by providing the parents with a modied Wong-
baker pain scale at different time intervals and
instructed on how to use it and asked them to
record the pain response at 12, 24, 48 and 72 hours
as told by the child. It was scored from zero to three
according to fourpoint facial pain intensity rating
scale, as follows: zero=no pain, one=slight pain,
two=moderate pain and three=severe pain [13].
b- Instrumentation time
In both groups, time was measured and
compared for both techniques. The time including
irrigation and instrument exchange was recorded
in minutes using a stopwatch from the beginning
of instrumentation until the preparation of canals
was completed [10].
c- Quality of obturation according to Shah et al. [11]
Two blinded independent assessors
evaluated the quality and extent of root canal
obturation by assessing voids and lling based
on the following criteria:
Score 0 – Complete absence of voids
Score 1 – Presence of one void
Score 2 – Presence of two voids
Score 3 – Presence of three voids
Score 4 – Presence of four voids
Score 5 – Presence of ve voids.
Extent of lling:
Grade A – Less than one half of the canal
obturated
Grade B – Greater than one half but less than
optimal ll
Grade C – Optimal ll
Grade D – Extrusion of material beyond apex
d- Assessment of clinical and radiographic
outcome (Morankar et al. [10]):
Clinical evaluation was carried on 1w, 3,
6, 9, 12 months; while radiographically was on
1 week, 6 and 12 months by two assessors who
were blinded to the treatment group. The teeth
were considered successful depending on the
clinical and radiographic criteria (Table I). As
these are considered composite outcomes. To
consider clinical success all clinical criteria should
be present. Otherwise, it was considered failure.
The same applied to the radiographic success.
Statistical analysis
Categorical and ordinal data were presented
as frequency and percentage values. Categorical
data were compared using chi-square test.
Parametric data (age) were compared using
independent t-test. Numerical data were
presented as mean and standard deviation
values. They were analysed for normality using
Shapiro-Wilk’s test. A Mann-Whitney U test was
used to compare ordinal data across groups,
while Friedman’s test followed by a Nemenyi
Figure 1 - Photograph showing acrylic radiographic stent attached
to Rinn XCP.
Table I - clinical and radiographic criteria
Clinical success criteria Radiographic success criteria
- Absence of tenderness to percussion.
- No abnormal mobility.
- Absence of swelling.
- Absence of fistula
- Decrease in the size of pre-operative radiolucency.
- No development of new radicular or furcation radiolucency.
- No development of pathologic internal or external resorption.
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Braz Dent Sci 2025 Jan/Mar;28 (1): e4538
Al-Wesabi AA et al.
Clinical and radiographic success following pulpectomy of primary molars with rotary instrumentation versus manual instrumentation: a 12-month randomized clinical trial
Al-Wesabi AA et al. Clinical and radiographic success following pulpectomy of
primary molars with rotary instrumentation versus manual
instrumentation: a 12-month randomized clinical trial
post hoc test was used to compare intragroup
data. Interexaminer reliability was analysed using
Cohen’s Kappa coefcient. Statistical analysis was
conducted using R statistical analysis software
version 4.1.3 for Windows (2022). A signicance
level of < 0.05 was used for all tests.
RESULTS
The study was conducted on 46 teeth
that were randomly and equally assigned to
both groups (i.e., 23 teeth each). The baseline
characteristic table (demographic data) in terms
of gender, age, number of root canals, caries
indices, extra and intraoral examinations are
shown in Table II.
An interexaminer reliability kappa test was
performed for the assessors, producing scores
with a statistically signicant strong agreement
between both (k=0.756, p<0.001).
Table III describes intergroup and intragroup
comparisons, after 12 and 48 hours, the
intervention group (A) had signicantly lower
pain severity than group (B) (
p
<0.05), while for
other intervals the difference was not statistically
signicant (
p
>0.05). In addition, for both groups,
there was a statistically signicant difference
between values measured at other intervals with
the highest pain severity measured at 12 hours
(
p
<0.001) and decreased over a period of time.
Analgesics were provided only for one case in
each group (the rotary and the control group).
The cases were evaluated at 2, 6, 9 and 12
months according to clinical and radiographic
criteria. The number of teeth per group at
different study periods is shown in the consort
owchart Figure 2.
Table IV describes intergroup comparisons,
values of frequency and percentage for clinical
outcomes in different groups at 12 months. After
12 months, there was a 4(17.4%) failed cases in
group (A) and no dropout, while in group (B)
there was 3(13.0%) failed cases and a single
dropout and the difference between both groups
was not statistically signicant (p=0.565).
While Table V describes intergroup
comparisons, values of frequency and percentage
for radiographic outcomes in different groups
at 12 months. The result revealed that there
was 5(21.7%) failed cases in group (A) and
no dropout, while in group (B) there was a
4(17.4%) failed cases and a single dropout and
the difference between both groups was not
statistically signicant (
p
=0.574).
Table II - Baseline characteristic table
Parameter Group
(A)
Group
(B)
p
-value
Gender1
Male n 13 14
0.765ns
% 56.5% 60.9%
Female n 10 9
% 43.5% 39.1%
Age2Mean±SD 5.24±0.61 5.28±0.61 0.812ns
Extra-oral
examination1
Yes n 1 1
1ns
% 4.3% 4.3%
No n 22 22
% 95.7% 95.7%
Dmf3Mean±SD 6.00±2.19 6.26±3.30 0.690
Def3Mean±SD 7.71±2.87 8.50±1.29 0.443ns
DMF Mean±SD 0.00±0.00 0.00±0.00 NA
Number of
canals1
Three n 5 9
0.200ns
% 21.7% 39.1%
Four n 18 14
% 78.3% 60.9%
Tenderness 1
Yes n 15 18
0.326ns
% 65.2% 78.3%
No n 8 5
% 34.8% 21.7%
Fistula1
Yes n 2 2
1ns
% 8.7% 8.7%
No n 21 21
% 91.3% 91.3%
Mobility1
Yes n 0 0
NA
% 0.0% 0.0%
No n 23 23
% 100.0% 100.0%
Swelling1
Yes n 3 3
1ns
% 13.0% 13.0%
No n 20 20
% 87.0% 87.0%
Furcation
radiolucency1
Yes n 5 3
0.437ns
% 21.7% 13.0%
No n 18 20
% 78.3% 87.0%
Periapical
radiolucency1
Yes n 4 4
1ns
% 17.4% 17.4%
No n 19 19
% 82.6% 82.6%
External root
resorption1
Yes n 0 0
NA
% 0.0% 0.0%
No n 23 23
% 100.0% 100.0%
Internal root
resorption1
Yes n 0 0
NA
% 0.0% 0.0%
No n 23 23
% 100.0% 100.0%
ns; non-significant (p>0.05) NA; Not Applicable; Standard deviation
(SD); 1; Chi-square test, 2; Independent t-test, 3; Mann-Whitney U
test.
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Braz Dent Sci 2025 Jan/Mar;28 (1): e4538
Al-Wesabi AA et al.
Clinical and radiographic success following pulpectomy of primary molars with rotary instrumentation versus manual instrumentation: a 12-month randomized clinical trial
Al-Wesabi AA et al. Clinical and radiographic success following pulpectomy of
primary molars with rotary instrumentation versus manual
instrumentation: a 12-month randomized clinical trial
For a case to be considered having overall
outcome success, it should have both clinical and
radiographic success.
Table VI shows the overall clinical and
radiographic outcomes after 12 months, there
was a 5(21.7%) failed cases in both groups, a
single dropout in group (B), and the difference
between both groups was not statistically
signicant (
p
=0.598).
Table VII states the instrumentation time per
group of treatment (min:sec) (minutes/seconds).
The instrumentation time in the control group
was signicantly higher than the intervention
group (
p
<0.001).
Table III - Inter, intragroup comparisons, frequency and percentage values for postoperative pain in different groups
Time Pain
Rotary Group (A) Manual Group (B)
p
value1
N (%) N (%)
12h
None 7A (30.4%) 2A (8.7%)
0.004*
Mild 11 (47.8%) 6 (26.1%)
Moderate 1 (4.3%) 3 (13.0%)
Severe 4 (17.4%) 12 (52.2%)
24hr
None 17B (73.9%) 11B (47.8%)
0.052ns
Mild 2 (8.7%) 2 (8.7%)
Moderate 3 (13.0%) 6 (26.1%)
Severe 1 (4.3%) 4 (17.4%)
48hr
None 20B (87.0%) 13B(56.5%)
0.022*
Mild 2 (8.7%) 5 (21.7%)
Moderate 1 (4.3%) 5 (21.7%)
Severe 0 (0.0%) 0 (0.0%)
72hr
None 19B (82.6%) 15B(65.2%)
0.189ns
Mild 4 (17.4%) 8 (34.8%)
Moderate 0 (0.0%) 0 (0.0%)
Severe 0 (0.0%) 0 (0.0%)
p-value2<0.001* <0.001*
Different superscript letters indicate a statistically significant difference within the same vertical column*. significant (
p
≤ 0.05) ns; non-
significant (
p
>0.05). 1; Mann-Whitney U test, 2; Friedman’s test.
Table VI - Intergroup comparisons, frequency and percentage values for overall clinical and radiographic outcomes in different groups.
Parameter
Groups
p
-value1
Rotary Group (A) Manual Group (B)
n % N %
Success 18 78.3% 17 73.9%
0.598nsFailure 5 21.7% 5 21.7%
Dropout 0 0.0% 1 4.3%
ns; non-significant (p>0.05). 1; Chi-square test.
Table V - Intergroup comparisons, frequency and percentage values for radiographic outcomes in different groups at 12 months
Parameter
RADIOGRAPHIC EVALUATION
p
-value1
Rotary Group(A) Manual Group (B)
n % N %
Success 18 78.3% 18 78.3%
0.574nsFailure 5 21.7% 4 17.4%
Dropout 0 0.0% 1 4.3%
ns; non-significant (p>0.05). 1; Chi-square test.
8
Braz Dent Sci 2025 Jan/Mar;28 (1): e4538
Al-Wesabi AA et al.
Clinical and radiographic success following pulpectomy of primary molars with rotary instrumentation versus manual instrumentation: a 12-month randomized clinical trial
Al-Wesabi AA et al. Clinical and radiographic success following pulpectomy of
primary molars with rotary instrumentation versus manual
instrumentation: a 12-month randomized clinical trial
Table VIII describes intergroup comparison,
frequency and percentage values for quality of
obturation in different groups, no significant
difference was observed between both groups
regarding the presence of voids (
p
=0.667) and
the extent of lling (
p
=0.261).
Case presentation for both groups are shown
in Figure 3 and Figure 4.
DISCUSSION
Pulpectomy in primary teeth has high success
rates, which make most of the practitioners
choose them over tooth extraction and space
maintainer. However, pulpectomy is considered
a challenge in pediatric dentistry [19].
To our knowledge, this is the rst study that
compared the postoperative pain, clinical and
radiographic success of Fanta baby rotary les
le with Manual K-les in primary molars teeth.
Our study focused on children aged 4-6 years
old because this is the most suitable age group
with signicant root length and to perform the
study away from the age of normal physiologic
root resorption as well as children younger than
Figure 2 - CONSORT Flow chart showing the number of teeth involved in the two groups at different study periods.
Table IV - Intergroup comparisons, frequency and percentage values for clinical outcomes in different groups at 12 months
Parameter
CLINICAL EVALUATION
p
-value1
Rotary Group (A) Manual Group (B)
n % n %
Success 19 82.6% 19 82.6%
0.565ns
Failure 4 17.4% 3 13.0%
Dropout 0 0.0% 1 4.3%
ns; non-significant (p>0.05). 1;Chi-square test.
Table VII - Showing instrumentation time per group of treatment (min: sec)
Groups of treatment N Mean±SD
P
Value1
Rotary group (A) 23 12:05±02:09 <0.001*
Manual group (B) 23 17:14±02:17
*; significant (p ≤ 0.05) ns; non-significant (p>0.05); Standard deviation (SD). 1; Independent t-test.
9
Braz Dent Sci 2025 Jan/Mar;28 (1): e4538
Al-Wesabi AA et al.
Clinical and radiographic success following pulpectomy of primary molars with rotary instrumentation versus manual instrumentation: a 12-month randomized clinical trial
Al-Wesabi AA et al. Clinical and radiographic success following pulpectomy of
primary molars with rotary instrumentation versus manual
instrumentation: a 12-month randomized clinical trial
Table VIII - Intergroup comparisons, frequency and percentage values for quality of obturation in different groups
Parameter
Groups
p
-value1
Rotary Group (A) Manual Group (B)
n % n %
Presence of voids
Complete absence of voids 13 56.5% 15 65.2%
0.667nsPresence of one void 6 26.1% 6 26.1%
Presence of two voids 4 17.4% 2 8.7%
Extent of filling
Greater than half but less than
optimal fill 5 21.7% 10 43.5%
0.261ns
Optimal fill 11 47.8% 9 39.1%
Extrusion of material beyond apex 7 30.4% 4 17.4%
ns; non-significant (p>0.05).1; Chi-square test.
Figure 3 - Photograph showing clinical and radiographic photos for a case from the rotary instrumentation group at different intervals. (a) preoperative
clinical photo showing lower left second primary molar, (b) preoperative radiograph showing lower left second primary molar, (c) immediate post-
operative clinical photo showing lower left second primary molar with stainless steel crown, (d) immediate post-operative radiograph showing lower
left second primary molar with stainless steel crown, (e) radiograph showing lower left second primary molar with stainless steel crown at 6 months, (f)
clinical photo showing lower left second primary molar with stainless steel crown at 12 months and (g) radiograph showing lower left second primary
molar with stainless steel crown at 12 months. Case I: Baby Fanta rotary files instrumentation group.
Figure 4 - Photographs showing clinical and radiographic photos for a case from the manual instrumentation group at different intervals. (a) preoperative
clinical photo showing lower right second primary molar, (b) preoperative radiograph showing lower right second primary molar, (c)immediate post-
operative clinical photo showing lower right second primary molar with stainless steel crown, (d) immediate post-operative radiograph showing lower
right second primary molar with stainless steel crown, (e) radiograph showing lower right second primary molar with stainless steel crown at 6 months,
(f) clinical photo showing lower right second primary molar with stainless steel crown at 12 months and (g) radiograph showing lower right second
primary molar with stainless steel crown at 12 months. Case II: Manual K-file instrumentation group.
10
Braz Dent Sci 2025 Jan/Mar;28 (1): e4538
Al-Wesabi AA et al.
Clinical and radiographic success following pulpectomy of primary molars with rotary instrumentation versus manual instrumentation: a 12-month randomized clinical trial
Al-Wesabi AA et al. Clinical and radiographic success following pulpectomy of
primary molars with rotary instrumentation versus manual
instrumentation: a 12-month randomized clinical trial
the age of 4 are easily affected by any stimuli
and have more a propensity to show negative
behaviors. Teeth with pathologic root resorption
and teeth with less than two third of each root
remaining were excluded from the study similar
to Shah et al. [11] and Cademartori et al. [20].
Lower second primary molars were selected
in this study for standardization as it is easier
and accessible for practical work and for more
precisely diagnosis of radiographic changes
(pathology and healing) than in upper molars
due to the reduced overlap of permanent lower
tooth buds on the bifurcation of the lower primary
molars [11,21].
Since the angle at which the radiograph is taken
is extremely critical. All postoperative radiographs
were taken with a custom-made stent for each
child and the Rinn XCP lm holding instrument
with the same exposure parameters. So, we will be
able to compare the preoperative and immediate
postoperative x-rays without consideration of
differences in the radiographic angle [21].
The intensity of postoperative pain was
greatest at 12 hours after treatment and gradually
decreased irrespective of instrumentation
techniques. This is in agreement with several
studies evaluating the duration of postoperative
pain after RCT [8,9]. This could be due to
the possible irritation of the periapical area
during endodontic treatment that causes local
inflammatory response and decreases after
healing of the periapical area [22].
Postoperative pain in the control group was
signicantly higher than in the rotary group with
statistically signicant differences at 12 and 48
hours. These results were consistent with those
of previous trials of Topçuoğlu et al. [8] and
Nair et al. [9] The less postoperative pain in
the rotary group might be explained by early
preflaring using Fanta baby’s orifice opener
file. By preflaring, any cervical obstruction is
eliminated, so irrigants can reach the canal
easily according to Subramaniam et al. [23] and
less debris and microorganisms are extruded
apically during instrumentation as stated by
Topçuoğlu et al. [8].
Regarding instrumentation time, the study
results showed that the manual group provided
signicantly longer time than the rotary group
during canals preparation which corresponded with
the ndings of several previous studies [24,25].
It is possible that the higher time required
for the manual instrumentation is due to a
greater number of manual files with a lower
cutting potential. In turn, this will cause fatigue
during instrumentation and ultimately result
in a decrease in the operator performance.
Our findings, however, were contradicted by
Madan et al. [26] and Katge et al. [27] who
found that rotary le systems increased root canal
instrumentation time in primary teeth. This was
attributed to the number of rotary instruments
used and operator’s experience.
In other word, the instrumentation time
in rotary group was at a lower rate (mean
12:05±02:09) than the instrumentation time
found by Morankar et al. [10] (19.37 ± 4.94
min) and Babu and Kavyashree [24] (mean
14.56 ± 2.89 min), while it was longer than that
by Makarem et al. [28] (10.1±1.71 min) and
Priyadarshini et al. [18] (3.4827 ± 0.48 min).
This is explained by variations the number of
rotary les used.
Regarding the quality of obturation, the
manual group in our study showed a higher
percentage of underlled root canals than the
rotary group. The problem could be due to the
use of a less elastic and tapered manual file,
resulting in narrow irregular debrided canals
that prevent proper obturating material ow.
Although there was no statistically signicant
difference between both groups. This result
is in accordance with Govindaraju et al. [29],
Sruthi et al. [30] and Lakshmanan et al. [31]
reported higher optimal filled teeth in rotary
group and higher underlled teeth in manual
group respectively with no statistically signicant
difference between the two groups. On the
contrary, Priyadarshini et al. [18] and Babu and
Kavyashree [24] reported statistically signicant
differences in obturation quality between both
groups. Extrusion of material beyond apex
was more in rotary group than manual group,
although there were no signicant differences
in both groups. This result is similar with
Divya et al. [32] who found more overlling in
rotary group with statistical signicant difference
between both groups.
Another critical aspect of obturation is the
voids’ incidence. In our study, the presence
of voids in obturation was not significantly
different between the rotary and manual groups.
Accordingly, this suggests that rotary files
11
Braz Dent Sci 2025 Jan/Mar;28 (1): e4538
Al-Wesabi AA et al.
Clinical and radiographic success following pulpectomy of primary molars with rotary instrumentation versus manual instrumentation: a 12-month randomized clinical trial
Al-Wesabi AA et al. Clinical and radiographic success following pulpectomy of
primary molars with rotary instrumentation versus manual
instrumentation: a 12-month randomized clinical trial
allow for proper obturations with less chairside
time required. This result is in consistent with
Shah et al. [11] and Lakshmanan et al. [33].
Based on a prior paper conducted by
Morankar et al. [10], clinical and radiographic
follow up visits were after 3, 6, 9 and 12
months. The two blinded independent assessors
interpreted radiographs with strict success/
failure criteria. Then, an interexaminer reliability
kappa test was performed for these assessors,
producing scores with a statistically signicant
strong agreement between both assessors.
Regarding clinical evaluations, our study
showed no statistically significant difference
in clinical parameters including tenderness
to percussion, gingival swelling, fistulas, and
pathological tooth mobility between the two
groups at the different follow up period. However,
there was significant reduction in tenderness
within each group through follow up period with
marked improvement after treatment. This result
is in accordance with Elheeny et al. [34] who
stated no statistical signicant difference in all
clinical parameters between both groups, while
there was high statistical signicant difference in
all clinical parameters within each groups.
At 12 months, the clinical success at our
study was 82.6% with no statistically signicant
difference in both groups. These ndings are in
line with those obtained by Elheeny et al. [34] ,
who revealed no statistically signicant difference
in term of clinical success rates in the rotary
and manual groups. On the contrary, Babu and
Kavyashree [24] and Amorim et al. [35] reported
that clinical success rate during the 12 months
follow up was 100% in both groups.
The rst sign of failure may be periapical
or/and furcation radiolucency followed by
external root resorption, especially as the failure
progresses. This failure was observed in both
groups and continued until the end of the study
period. There was no statistically significant
difference between both groups. This result goes
in accordance with Babu and Kavyashree [24]
who reported development of a new radiolucency.
At 12 months, radiographic success in both
groups was 78.3% and statistically significant
difference was not observed. Our nding was higher
than radiographic success in rotary and manual
group (66.7%,65.4% respectively) obtained by
Morankar et al. [10], while it was relatively lower
than those (100%, 95.8% respectively) obtained
by Babu and Kavyashree [25].
Apart from the type of instrumentation
technique in both groups, a possible explanation
of these similar success rates in both groups
may be attributed to proper eld isolation, use
of copious amounts of suitable irrigants, type
of obturation material and hermitic seal post
restoration, all of which are considered critical
factors for pulpectomy success.
In our study, the possible reasons for
radiographic failure observed in both groups
may be attributed to the inherent problems in
primary molars as (connecting brils, partial fusion
of canals, accessory canals, lateral branching,
apical ramication, thin apical isthmus and root
curvature) leading to incomplete removal of
inamed/necrotic tissues.In addition to persistence
of bacteria in the canals and apex and the presence
of more resistant microorganisms [36].
While the differences between our ndings
and those of previous studies may likely be
attributed to differences in teeth chosen, type of
rotary instruments used and type of irrigating
solutions as well as operator skills and experience.
Our study found that the clinical success
was higher than radiographic success in both
groups, this result was evident in study previously
conducted by Morankar et al. [10] which declare
that, radiographic success rates have been found
to be lower than the clinical success rates. As
cited by Elheeny et al. [34], this may be because
failure of pulp therapy treatment is rst detected
radiographically and tooth could be remained
asymptomatic clinically until natural exfoliation
of the patient teeth.
Additionally, our study showed that the
overall clinical and radiographic success in rotary
and manual groups were 78.3% and 73.9%
respectively. These results differ from those
obtained by Kuo et al. [37] who reported overall
clinical and radiographic success rates in rotary
group was 95%. This higher success rate may be
accounted for that majority of the selected teeth
had acute pulpitis as cited by Elheeny et al. [34].
In our study, the difference between both
groups was not statistically signicant regarding
clinical and radiographic failure. This result was
supported by Elheeny et al. [34] who found nearly
similar number of failed cases in rotary group and
in manual group, while Morankar et al. [10]
12
Braz Dent Sci 2025 Jan/Mar;28 (1): e4538
Al-Wesabi AA et al.
Clinical and radiographic success following pulpectomy of primary molars with rotary instrumentation versus manual instrumentation: a 12-month randomized clinical trial
Al-Wesabi AA et al. Clinical and radiographic success following pulpectomy of
primary molars with rotary instrumentation versus manual
instrumentation: a 12-month randomized clinical trial
found similar number in rotary group but higher
in manual group.
It is worth to mention that we faced some
difculties in comparing our results with other
studies having the same aim due to differences in
the type of rotary systems used in other studies.
Furthermore, there have been limited clinical
trials that evaluate the clinical and radiographic
outcomes of using rotary systems for instrumenting
primary molars. Consequently, there were no
comparison data available for Fanta baby rotary
les regarding clinical and radiographic success.
Study strength:
This is the rst randomized clinical trial using
the Fanta baby rotary les compared to manual
les. Thus, there is no clinical data available for
Fanta baby rotary les. A standardized technique
was performed through this trial in both groups.
Study limitations:
1- The postoperative pain used is a subjective
method of evaluation where children can
state that they are in pain but actually they
do not feel pain, they might recall their
previous pain as if it is present.
2- A further limitation was the inability to blind
the operator and participating children due
to notable differences in instrumentation
techniques.
3- It is also worth mentioning that we followed
manufacturers recommendations, to use
EDTA with rotary systems; whereas EDTA
was not used with the manual les group.
Thus, the imputation of using EDTA with
both rotary and manual systems need to be
furtherly investigated.
Despite these limitations, the study
contributes meaningful preliminary data on the
relationship between [rotary /manual ] which
can guide subsequent research in this area.
CONCLUSIONS
We concluded that Fanta baby rotary les
provide less postoperative pain after pulpectomy
procedures compared to the manual files. In
addition, there was no statistically significant
difference between both groups in clinical
and radiographic success after 12 months. No
signicant difference was observed between both
groups regarding the presence of voids and the
extent of lling. Further studies are needed using
larger sample sizes and diverse materials and more
objective parameters are required to strengthen the
evidence. Also, future studies with larger sample
sizes specically powered for secondary outcomes
are recommended to conrm our ndings and
further explore their clinical implications.
Acknowledgements
The authors are grateful to all children and
their parents/ guardians who participated in the
study.
Author’s Contributions
AAW: conceptualization, methodology,
investigation, formal analysis, writing-
review&editing, writing-Original draft preparation.
KE: conceptualization, methodology, formal
analysis, writing- review & editing. AMAA:
conceptualization, methodology, investigation,
formal analysis, writing-review & editing. FA:
conceptualization, methodology, investigation,
formal analysis, writing- review &editing, writing-
Original draft preparation.
Conict of Interest
No conflicts of interest were declared
concerning the publication of this article.
Funding
The authors declare that no nancial support
was received.
Regulatory Statement
Before the commencement of research, the
ethical approval for the current study was obtained
from Research Ethics Committee, Faculty of
Dentistry, Cairo University with approval number
(34-9-19) following the declaration of Helsinki
for human subject research. Prior to the beginning
of the study, an informed consent was obtained
from the parents/guardians of all the children
who had enrolled for the study.
LIST OF ABBREVIATIONS
dmf = decay, missing, lling
13
Braz Dent Sci 2025 Jan/Mar;28 (1): e4538
Al-Wesabi AA et al.
Clinical and radiographic success following pulpectomy of primary molars with rotary instrumentation versus manual instrumentation: a 12-month randomized clinical trial
Al-Wesabi AA et al. Clinical and radiographic success following pulpectomy of
primary molars with rotary instrumentation versus manual
instrumentation: a 12-month randomized clinical trial
EDTA= Ethylenediaminetetraacetic acid
min: sec = minuets: second
Ni-Ti = Nickel-titanium
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14
Braz Dent Sci 2025 Jan/Mar;28 (1): e4538
Clinical and radiographic success following pulpectomy of
primary molars with rotary instrumentation versus manual
instrumentation: a 12-month randomized clinical trial
Al-Wesabi AA et al.
Clinical and radiographic success following pulpectomy of primary molars with rotary instrumentation versus manual instrumentation: a 12-month randomized clinical trial
Al-Wesabi AA et al. Clinical and radiographic success following pulpectomy of
primary molars with rotary instrumentation versus manual
instrumentation: a 12-month randomized clinical trial
Date submitted: 2024 Oct 06
Accept submission: 2025 Jan 24
Azhar Abdulrahman Al-Wesabi
(Corresponding address)
Cairo University, Faculty of Dentistry, Pediatric Dentistry and Dental Public Health
Department, Cairo, Egypt.
Hodeidah University, Faculty of Dentistry, Department of Pediatric Dentistry,
Hodeidah, Yemen.
Emails: Azhar-ali@dentistry.cu.edu.eg, Azharali5255@gmail.com
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