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.2024.e4285
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Braz Dent Sci 2024 July/Sept;27 (3): e4285
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.
Comparative evaluation of post operative pain after irrigation with
different concentrations of sodium hypochlorite: a split mouth
triple blinded randomized controlled trial
Avaliação comparativa da dor pós-operatória após irrigação com diferentes concentrações de hipoclorito de sódio: um
estudo randomizado e controlado, triplo-cego, de boca dividida
Divya MUKUNDAN1 , Vignesh RAVINDRAN1
1 - Department of Pediatric and Preventive Dentistry, Saveetha Dental College and Hospitals, Saveetha Institute of Medical and Technical
Sciences, Saveetha University, Chennai, Tamilnadu, India
How to cite: Mukundan D, Ravindran V. Comparative evaluation of post operative pain after irrigation with different concentrations of
sodium hypochlorite: a split mouth triple blinded randomized controlled trial. Braz Dent Sci. 2024;27(3):e4285.
https://doi.org/10.4322/bds.2024.e4285
ABSTRACT
Objective: Post-endodontic pain is a frequently occurring adverse outcome that impacts a patient’s recovery
after a root canal procedure. A range of 4% to 50% of patients experienced moderate-to-severe discomfort after
undergoing endodontic therapy. American Association of Pediatric Dentistry (AAPD) standards recommend
treating primary teeth with 1% sodium hypochlorite irrigation. Despite its widespread use, there is no study
comparing postoperative outcomes of 1% sodium hypochlorite and higher concentrations. The aim of this study
was to compare the postoperative pain following pulpectomy procedures in primary teeth irrigated with 1%
sodium hypochlorite versus those irrigated with a higher concentration of 3% sodium hypochlorite. Materials
and Methods: This study was a split mouth trial. A total of 36 participants were allocated into two groups. In
group 1, canal was irrigated using 1% sodium hypochlorite solution, and in group 2 canal was irrigated using
3% sodium hypochlorite solution. Results: Post operative pain after the procedure was evaluated using a visual
analogue scale at four specic time intervals baseline, 6 hours, 12 hours and 24 hours. However, 8 participants
who took analgesics were excluded, resulting in 28 participants. The paired t test was utilized to evaluate the
difference between two groups. At 6 hours, the 1% NaOCl group reported considerably less pain than 3% NaOCl
group with a p value 0.003. However, at 12 hours and 24 hours there was no statistical difference between the
groups with a p value >0.005. Conclusion: This study indicates that, in comparison to higher concentrations,
the use of 1% sodium hypochlorite showed reduced postoperative discomfort.
KEYWORDS
Irrigation; Pain; Primary teeth; Pulpectomy; Sodium hypochlorite.
RESUMO
Objetivo: A dor após um procedimento de canal radicular é um efeito adverso frequente que afeta a recuperação
do paciente após um procedimento de canal radicular. De 4% a 50% dos pacientes apresentaram desconforto
moderado a grave após a terapia endodôntica. Os padrões da Associação Americana de Odontologia Pediátrica
(AAPD) recomendam o tratamento de dentes decíduos com irrigação de hipoclorito de sódio a 1%. Apesar de seu
uso generalizado, não há nenhum estudo que compare os resultados pós-operatórios do hipoclorito de sódio a
1% e de concentrações mais altas. O objetivo deste estudo foi comparar a dor pós-operatória após procedimentos
de pulpectomia em dentes decíduos irrigados com hipoclorito de sódio a 1% com aqueles irrigados com uma
concentração mais alta de hipoclorito de sódio a 3%. Material e Métodos: Esse estudo foi um ensaio de boca
dividida. Um total de 36 participantes foi alocado em dois grupos. No grupo 1, o canal foi irrigado com solução
de hipoclorito de sódio a 1% e, no grupo 2, o canal foi irrigado com solução de hipoclorito de sódio a 3%.
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Braz Dent Sci 2024 July/Sept;27 (3): e4285
Mukundan D et al.
Comparative evaluation of post operative pain after irrigation with different concentrations of sodium hypochlorite: a split mouth triple blinded randomized controlled trial
Mukundan D et al. Comparative evaluation of post operative pain after irrigation
with different concentrations of sodium hypochlorite: a split
mouth triple blinded randomized controlled trial
INTRODUCTION
Primary teeth are essential for phonetics,
aesthetics, mastication, and maintaining space
for permanent teeth. Hence, preserving primary
teeth holds important signicance. Children who
have poor dental hygiene practices are prone
to experiencing frequent occurrences of severe
dentinal caries, discomfort, and swelling [1].
Pulpectomy is a procedure that refers to the
removal of the roof of the pulp chamber to
provide access to the root canals. These canals are
then cleaned, shaped, disinfected, and lled with
a material that is resorbable. Consequently, the
tooth can be preserved in the dental arch while
maintaining the tooth’s functionality [2].
Pulpectomy is considered as an alternative
option to tooth extraction in cases of irreversible
pulpitis or dental pulp necrosis. Bacteria and the
byproducts they produce in root canal systems are a
major cause of pulpal and periapical infections [3].
Therefore, in order to eradicate infection from
the root canal, it is essential to perform chemo
mechanical preparation and irrigation using
antibacterial solutions. This is necessary to
reduce the presence of microorganisms and their
byproducts. Because of the complexities of the
root canal, chemical irrigation and mechanical
preparation play an important role in achieving
appropriate disinfection [4,5].
Sodium hypochlorite (NaOCl) is well
recognized as the predominant irrigation
solution in endodontics for over 70 years
because of its potent antibacterial characteristics
and exceptional ability to dissolve tissues.
The effectiveness of NaOCl in dissolving organic
soft tissue and biolms is directly linked to its
concentration. This higher concentration has
an ability to irritate the periapical tissues [6].
The toxicity of endodontic irrigant to periapical
tissues is a serious concern, especially when
treating children in paediatric dentistry. Because
of the possibility of resorption areas, it is crucial
to exercise caution when it comes to the overow
of irrigating solution via the apical region of
primary teeth. This might result in damage to the
permanent tooth bud underneath.
A study by Wang et al. [7] showed that a
higher concentration of 6% NaOCl resulted in
enhanced antibacterial efcacy, nevertheless,
the adverse consequence was that it had
the potential to harm the periapical tissues
and increase cytotoxicity if it was forced out
beyond the apical foramen. An in vivo study by
Liapis et al. [8] revealed a notable difference
in the cytotoxicity of varying concentrations of
NaOCl employed as the irrigant. This finding
implies a greater probability of experiencing post-
operative pain in clinical scenarios when a higher
concentration of 3% NaOCl was used.
Post-endodontic pain is a frequently
occurring adverse outcome that impacts a patient’s
recovery after a procedure. A range of 4% to
50% of patients experienced moderate-to-severe
discomfort after undergoing endodontic therapy,
regardless of whether their pulps were necrotic
or vital [9]. Multiple reports have specically
addressed these potential complications [10,11].
There are, however, few evidence-based studies
that assessed postoperative pain using various
NaOCl irrigation concentrations.
In accordance with the American Association
of Pediatric Dentistry (AAPD) guidelines [12],
the use of 1% sodium hypochlorite irrigation
has been established in the treatment of primary
teeth. However, despite its common practice,
there remains a gap in research specifically
comparing the postoperative outcomes between
the utilization of 1% sodium hypochlorite and
higher concentrations. Thus, this study was
conducted to compare the postoperative pain
following pulpectomy procedures in primary
Resultados: A dor pós-operatória após o procedimento foi avaliada por meio de uma escala visual analógica em
quatro intervalos de tempo especícos: 6 horas, 12 horas e 24 horas. No entanto, 8 participantes que tomaram
analgésicos foram excluídos, resultando em 28 participantes. O teste t pareado foi utilizado para avaliar a
diferença entre os dois grupos. Em 6 horas, o grupo do NaOCl a 1% relatou consideravelmente menos dor do que
o grupo do NaOCl a 3%, com um valor de p de 0,003. Entretanto, após 12 horas e 24 horas, não houve diferença
estatística entre os grupos, com um valor de p >0,005. Conclusão: Este estudo indica que, em comparação com
concentrações mais altas, o uso de hipoclorito de sódio a 1% reduziu o desconforto pós-operatório.
PALAVRAS-CHAVE
Irrigação; Dor; Dentes decíduos; Pulpectomia; Hipoclorito de sódio.
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Braz Dent Sci 2024 July/Sept;27 (3): e4285
Mukundan D et al.
Comparative evaluation of post operative pain after irrigation with different concentrations of sodium hypochlorite: a split mouth triple blinded randomized controlled trial
Mukundan D et al. Comparative evaluation of post operative pain after irrigation
with different concentrations of sodium hypochlorite: a split
mouth triple blinded randomized controlled trial
teeth irrigated with 1% sodium hypochlorite
versus those irrigated with a higher concentration
of 3% sodium hypochlorite.
MATERIAL & METHODS
Study design
The present investigation was conducted
as a split-mouth, triple blinded, randomized
controlled experiment.
Study setting
The study was carried out at a private dental
institution in Chennai in the Department of
Paediatric and Preventive Dentistry.
Ethical clearance
The institutional ethics committee (IHEC/
SDC/PEDO-2101/23/140) authorized the
study before its commencement. The study
was registered with the Clinical Trials Registry
India (CTRI) with a registration number
CTRI/2023/11/059520. Parents gave written
informed consent. The participants remained
anonymous.
Study population
Patients visiting the Paediatric dental
outpatient department between November
2023 and December 2023, aged 4 to 8 years,
were included in the study. A total of thirty six
children were assigned to two groups using a
random allocation process.
Inclusion criteria
Children requiring pulpectomy procedure for
two primary mandibular posterior teeth, children
belonging to Frankl 2 and 3 ratings during the
examination process, participants belonging
to American Society of Anaesthesiologists
1 category.
Exclusion criteria
Teeth with calcified canals, crowns that
cannot be restored, or showing evidence of
signicant internal or external root resorption.
Children with any systemic disorder or medically
compromising conditions and children who had
been administered antibiotics within 2 weeks
prior to the procedure.
Sample size calculation
A preliminary pilot split mouth study was
conducted on ve patients to gather initial data
on pain levels following pulpectomy using 1%
and 3% sodium hypochlorite (NaOCl) solutions
as irrigants. The pilot data provided estimates of
variability and effect size, which were used in a
sample size calculation performed using MedCalc
software version 23.0.1. The objective was to
determine the number of participants required
to detect a signicant mean difference of 20%
in post-operative pain between the two groups,
with a targeted study power of 95% and an alpha
error of 0.05. The software program calculated a
sample size of 28 taking the effect size, variability,
and desired statistical power into account.
A total of 36 participants were initially enrolled
to account for potential dropouts, ensuring that
the required sample size was maintained for the
study. Data obtained from the pilot study were
not included in the nal trial.
Randomization
A computerized random number generator
created a randomized list, the allocation ratio
was 1:1 and the allocation sequence were
placed within an opaque, sealed envelope. Based
on the order of enrolment, the patients were
assigned numbers. A dental assistant opened
these envelopes at the time of the intervention.
The participants were divided into two groups,
each group consisting of 36 participants. In Group
1, the canals were irrigated using a 1% sodium
hypochlorite solution, and Group 2 with 3%
sodium hypochlorite solution. Data collection
was carried out by a dentist. The data collection
was conducted in a blinded manner, without
any differentiation between the participants.
Participants, operator and data collector were
blinded during the procedure.
Procedure
Before any dental intervention, participants
were instructed to record their perceived pain
intensity using a Visual Analogue Scale (VAS),
which provided a quantitative measure of pain.
Baseline pain assessment was done on the
day of the procedure. Each patient underwent
a single-visit pulpectomy performed by a
trained Paediatric dentist. An Inferior Alveolar
Nerve Block and a lingual nerve block were
administered following the application of topical
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Braz Dent Sci 2024 July/Sept;27 (3): e4285
Mukundan D et al.
Comparative evaluation of post operative pain after irrigation with different concentrations of sodium hypochlorite: a split mouth triple blinded randomized controlled trial
Mukundan D et al. Comparative evaluation of post operative pain after irrigation
with different concentrations of sodium hypochlorite: a split
mouth triple blinded randomized controlled trial
anesthetic gel (Progel B-Benzocaine Gel 20%)
to both groups. A 30-gauge, 25 mm needle
(Hindustan syringes-Dispo van) was used to
deliver 1.5 mL of 2% lignocaine hydrochloride
with 1:100,000 adrenaline.
To isolate the tooth, a rubber dam was used.
Access to the pulp chamber was achieved with
a high-speed diamond round bur (#330). Upon
completion of the access cavity preparation, the
root canals were located. A 10 size K-le (Mani
les) was introduced into each canal, stopping
approximately 1 mm short of the root apex as
indicated by preoperative radiographs. Gentle
ling was performed in a watch winding motion,
followed by saline irrigation. The pulp tissue was
extirpated using a 15 size H-le (Mani les), with
subsequent irrigation using 1 ml of 1% or 3%
sodium hypochlorite.
Canal preparation was completed to the
working length using Kedo S Plus rotary les
(Kedo Files) in a clockwise direction, followed
by irrigation with 2 ml of 1% or 3% sodium
hypochlorite. Final canal preparation was
performed with Kedo S Plus rotary files, and
canals were subsequently irrigated with 5 ml of
saline. The canals were obturated with Calcium
hydroxide and Iodoform paste (Metapex, Met
Biomed, South Korea) and restored with Type IX
GIC (Glassionomer FX Ultra – Shofu INC, Japan).
Patients with under or over obturation were
excluded from the study. Analgesics, Paracetamol
250 mg was prescribed three times daily (TDS),
in cases of severe pain.
The pain was evaluated using a visual
analogue scale (VAS) at four specific time
intervals: baseline (before treatment), 6 hours,
12 hours and 24 hours after the procedure.
The pain level was recorded on a number
scale of 0-10, with 0 representing no pain,
1-3 representing mild pain, 4-6 representing
moderate pain, and 7-10 representing severe
pain. Patients were contacted by phone at certain
intervals following their visit to ensure that their
pain had been accurately recorded on the VAS.
They were directed to record the number of
analgesic pills if taken. Participants who have
taken analgesics were excluded from the study.
After a one-week interval, a similar
pulpectomy procedure was repeated on the
contralateral molar of the same participant
irrigating with 1% or 3% sodium hypochlorite
solution. Post-procedural pain was evaluated
and compared with the previous procedure,
considering the VAS ratings provided by the child.
Statistical analysis
The Normality tests Kolmogorov-Smirnov
and Shapiro-Wilks tests results reveal that
values follow Normal distribution. Therefore,
to analyse the data, parametric was applied.
Descriptive statistics was expressed using mean
and standard deviation. Inferential statistics was
done using paired t test to analyse comparison
of time interval between the groups. To analyse
the data SPSS (IBM SPSS Statistics for Windows,
Version 26.0, Armonk, NY: IBM Corp. Released
2019) was used. Signicance level is xed as
5% (α = 0.05). P-value 0.05 is considered to be
statistically signicant.
RESULTS
The current split-mouth study involved
36 children aged 4 to 8 years who underwent
pulpectomy. After 6 hours, 8 participants had
taken analgesics and were excluded from the study.
Consequently, 28 participants were included in
the nal analysis, with their demographic details
provided in Table I.
The pain scores for both the 1% and 3% sodium
hypochlorite irrigation groups exhibited a decrease
from baseline to 24 hours post irrigation. When
intra group comparison was done using paired t
test, there was a signicant reduction in pain score
from baseline to 24 hours with p value of 0.001 in
both the groups (Table II, Graph 1). However, when
intergroup comparison was done from baseline to
24 hours, there was signicant difference at 6 hours
with a p value 0.003 (Table III).
Table I - Demographic details of the patients participating in the
study
AGE
DISTRIBUTION FREQUENCY (N) PERCENTAGE (%)
4 years 5 17.9
5 years 13 46.4
6 years 7 25.0
7 years 1 3.6
8 years 2 7.1
GENDER
DISTRIBUTION FREQUENCY (N) PERCENTAGE (%)
FEMALE 22 78.6
MALE 6 21.4
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Braz Dent Sci 2024 July/Sept;27 (3): e4285
Mukundan D et al.
Comparative evaluation of post operative pain after irrigation with different concentrations of sodium hypochlorite: a split mouth triple blinded randomized controlled trial
Mukundan D et al. Comparative evaluation of post operative pain after irrigation
with different concentrations of sodium hypochlorite: a split
mouth triple blinded randomized controlled trial
DISCUSSION
Ensuring the prevention and effective
management of pain during endodontic
therapy is crucial for successful treatment.
The cause of pain or discomfort after pulpectomy
procedure is multifactorial and depends upon the
immunological response of the host, infection, and
damage to peri apical tissues [13]. Nonsteroidal
anti-inammatory drugs (NSAIDs) have been
found to have limited efcacy in young children.
Research suggests that these medications may
not provide significant relief for pain and
inammation in this age group [14,15].
The primary objective of pulpectomy is to
thoroughly clean and shape the root canals,
ensuring the removal of all debris and bacteria-
laden tissue. By achieving this, the procedure
aims to minimize post-operative pain for the
patient. Irrigation plays an important role in post-
operative care for maintaining optimal healing
conditions. Hence the current study focused on
comparing the effectiveness of different sodium
hypochlorite concentrations on post-operative
pain.
Regarding the ideal NaOCl concentration
for root canal preparation, there is currently no
agreement. Although NaOCl has better tissue
dissolving characteristics, it also shows more
cytotoxicity at higher concentrations [16].
The majority of research on postoperative pain has
utilized concentrations of sodium hypochlorite
ranging from 2.5% to 5.25% or higher [17,18].
However, according to American Association of
Paediatric Dentistry (AAPD) guidelines [12], the
use of 1% sodium hypochlorite irrigation has
been recommended in the treatment of primary
teeth. Hence in the current study 1% NaOCl was
compared with a higher concentration of 3%
NaOCl.
Table II - Comparison of pain score within the group using Paired t test
Groups
Mean ± Std Deviation
P value
Baseline 6 hours 12 hours 24 hours
1% Sodium hypochlorite 4.428 ± 2.062 1.785 ± 1.370 0.785 ± 0.994 0.357 ± 0.780 0.001*
3% Sodium hypochlorite 4.214 ± 1.912 1.928 ± 1.488 0.714 ± 0.975 0.428 ± 0.835 0.001*
*Denotes the value obtained was statistically significant as significance level was set at 0.05.
Table III - Intergroup Comparison of pain score using Paired t test
Post operative pain 1% Sodium hypochlorite 3% Sodium hypochlorite P value
Baseline 1.474 ± 0.214 1.484 ± 0.326 0.449
6 hours 1.799 ± 0.142 1.892 ± 0.152 0.003*
12 hours 1.799 ± 0.071 1.878 ± 0.142 0.769
24 hours 1.274 ± 0.071 1.284 ± 0.091 0.713
*Denotes the value obtained was statistically significant as significance level was set at 0.05.
Graph 1 - Comparison of pain score within the group using Paired t test.
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Braz Dent Sci 2024 July/Sept;27 (3): e4285
Mukundan D et al.
Comparative evaluation of post operative pain after irrigation with different concentrations of sodium hypochlorite: a split mouth triple blinded randomized controlled trial
Mukundan D et al. Comparative evaluation of post operative pain after irrigation
with different concentrations of sodium hypochlorite: a split
mouth triple blinded randomized controlled trial
The current investigation was a randomized
split mouth study. Since pain perception varies
among individuals and the main objective of this
study was to evaluate the post operative pain, a
randomized split-mouth design was implemented
for this investigation. This study aimed to
assess postoperative pain in patients following
pulpectomy procedure with various irrigation
solutions, including 1% and 3% NaOCl, at
different time intervals. The current study utilized
the Visual Analogue Scale (VAS) to evaluate the
pain experienced after the procedure.
VAS is a well-recognized subjective pain
evaluation scale, consisting of a 10-centimeter
line with ends labelled as “no pain” and “worst
possible pain” to measure pain severity. Children
were instructed to mark their perceived pain level
on the line, allowing for a subjective but reliable
measure of pain intensity [19].
After 6 hours, 8 participants who had
taken analgesics were excluded from the study,
leaving 28 participants in the final analysis.
Among the excluded participants, 2 participants
were treated with 1% sodium hypochlorite and
6 with 3% sodium hypochlorite. Overall, there
was no signicant difference observed between
the irrigants used at 12, and 24 hours. However,
the group treated with a 1% concentration of
sodium hypochlorite experienced lower levels
of postoperative pain in the first six hours
following the procedure. This can be due to
higher concentrations of NaOCl can cause greater
tissue irritation due to their strong antimicrobial
and proteolytic properties. This increased irritant
effect might lead to more inflammation and
postoperative discomfort. Lower concentrations,
like 1% NaOCl, may be gentler on periapical
tissues, resulting in decreased irritation and
subsequent pain [19].
The ndings of the present study correlate
with the research conducted by Mostafa et al. [20]
who concluded that low concentration of NaOCl
irrigation resulted in less post operative pain when
compared to higher concentrations. Research
indicates that even at lower concentrations,
NaOCl effectively eliminates bacteria within
the root canal [21]. Hence, in addition to
efciently cleaning the canal, use of the lower
concentration solution may potentially reduce
tissue inammation and subsequent pain [22].
Moreover, according to Rôças and
Siqueira [23] it is assumed that lower
concentrations have a lesser detrimental effect
on vital structures including periapical tissues
and dentinal structures and the preservation
of vital structures may contribute to reducing
postoperative pain due to higher concentrations
of NaOCl. However, in contrast to the current
study result, a study by Farzaneh et al. [24]
reported less postoperative pain in 5.25% NaOCl
when compared to 2.5% NaOCl. It is important to
recognize that postoperative pain can arise from
multiple factors beyond the irrigation protocol.
Variables inuencing pain include pulp and apical
status, size of the periapical lesion, irrigation
pressure and size of the apical foramen.
The study has few limitations such as the
limited sample size, the short-term follow-up
period may not fully capture post-operative
discomfort. The narrow range of sodium
hypochlorite concentrations compared in the
present study. These limitations highlight the
need for larger, more diverse studies with
longer follow-up durations to better understand
the relationship between sodium hypochlorite
concentrations and root canal post-operative
pain.
CONCLUSION
Within the limitations of this study, the
results indicate that using 1% sodium hypochlorite
(NaOCl) was associated with lower post-operative
pain, suggesting a potential advantage over
higher concentrations.
Author’s Contributions
DM: Conceptualization, Methodology,
Formal Analysis, Investigation, Resources, Data
Curation, Writing – Original Draft Preparation.
VR: Conceptualization, Validation, Investigation,
Writing – Review & Editing, Visualization,
Supervision, Project Administration.
Conict of Interest
The authors have no conicts of interest to
declare.
Funding
This research did not receive any specic
grant from funding agencies in the public,
commercial, or not-for-prot sectors.
7
Braz Dent Sci 2024 July/Sept;27 (3): e4285
Mukundan D et al.
Comparative evaluation of post operative pain after irrigation with different concentrations of sodium hypochlorite: a split mouth triple blinded randomized controlled trial
Mukundan D et al. Comparative evaluation of post operative pain after irrigation
with different concentrations of sodium hypochlorite: a split
mouth triple blinded randomized controlled trial
Regulatory Statement
This study was conducted in accordance with
all the provisions of the local human subject’s
oversight committee guidelines and policies of
Clinical Trial Registry India. This study protocol
was reviewed and approved by Saveetha Dental
College – Institutional Human Ethical Committee
(SD-IHEC), approval number IHEC/SDC/PEDO-
2101/23/140. The study was registered with
the Clinical Trials Registry India (CTRI) with a
registration number CTRI/2023/11/059520
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8
Braz Dent Sci 2024 July/Sept;27 (3): e4285
Mukundan D et al.
Comparative evaluation of post operative pain after irrigation with different concentrations of sodium hypochlorite: a split mouth triple blinded randomized controlled trial
Mukundan D et al. Comparative evaluation of post operative pain after irrigation
with different concentrations of sodium hypochlorite: a split
mouth triple blinded randomized controlled trial
Vignesh Ravindran
(Corresponding address)
Department of Pediatric and Preventive Dentistry, Saveetha Dental College
and Hospitals, Saveetha Institute of Medical and Technical Sciences, Saveetha
University, Chennai, Tamilnadu, India
Email: vigneshr.sdc@saveetha.com
Date submitted: 2024 Feb 29
Accept submission: 2024 Sept 18
