PED IATRIC DENTISTRY V 35 I NO 4 JUL I AUG 13

Sodium Hypochlorite Vs Formocresol as Pulpotomy Medicaments in Primary Molars:

1-year Follow-up
Mahboobeh Shabzendedar, MS1 • Fatemeh Mazhari, MS 2 • Maliheh Alami 3 • Maryam Talebi, MS 4

Abstract: Purpose: The study evaluated the effects of 3 percent sodium hypochlorite (NaOCI} and formocresol (FC} as pulp dressing agents in
pulpotomized primary molars. Methods: One hundred children between three and six years each with at least one primary mandibular second
molar requiring pulpotomy were randomly allocated to two groups (of 50 each}. All the teeth received stainless steel crown after conventional
--- pulpotomy procedure with either NaOCI (applied for 15 second} or FC (applied for one minute). Clinical and radiographic signs/symptoms were
blindly recorded at zero, six. and 12 months. The differences were statistically analyzed using the Fisher's exact test. Results: At six months, 100
percent clinical success was found with both NaOCI, and FC. Radiographic success rates for NaOCI were 98 percent and 92 percent at 6- and
12-month recalls respectively. FC group showed 94 percent and 93 percent radiographic success rates at the same periods respectively. There
was no statistically significant difference between the groups. Conclusion: NaOCI can be suggested as a pulpotomy agent for primary teeth
pulpotomies. However further clinical studies with long-term follow-ups are needed to test the efficacy of NaOCI as a pulpotomy medicament
in primary teeth. (Pediatr Dent 2013;35:329-32} Received October 7, 2011 I Last Revision December 2, 2011 I Accepted December 4, 2011

KEYWORDS: SODIUM HYPOCHLORITE, FORMOCRESOL, PRIMARY TEETH, PULPOTOM Y

Pulpotomy is one of the most commonly used treatments in the Therefore, the purpose of this study was to compare the clinical
management of extensive caries in primary molars. 1 Pulpotomy and radiographic results of three percent sodium hypochlorite vs

-
treatment can be classified according to rhe following treatment
objectives: deviralizarion; preservation; or regeneration . 2 Formo-
cresol (FC) , a devitalizing agent, has been a popular pulpotomy
medicament for many yea rs. 1 D es pite its high success rate over
the past years, FC's use as a pulpotomy agent has been challenged
due to pulpal inflammatory response, 3 systemic disturbances, 4
cytotoxicity,5 immunologic responses, 6 and mutagenic and carci-
nogenic potential. 7
These findings have led researchers to look for an alternative
to FC. Accordingly, various materials such as glutaraldehyde, ferric
sulfate, mineral trioxide aggregate, freeze-dried bone, bone mor-
phogenic protein, osteogenic protein , and collagen have been
suggested, 1·8 as well as methods such as electrosurgery and laser
radiation. 9 ' 10
Aside from these suggested materials, sodium hypochlorite
(NaOCl) seems to be a suitable alternative for FC. Used for over
four decades 11 as the most popular endodontic irrigant available,
it has been shown to be a very good antimicrobiaP 2 and hemo-
static agent, 13 two important factors in primary teeth pulpotomy.
Hafez et al. have performed two histological studies and re-
ported NaOCl to be biologically compatible with exposed pulp
tissue when used as a hemostatic agent in direct pulp capping. 14- 15
Rosenfeld er al. demonstrated that using five percent NaOCl had
superficial effects on pulpal tissue, and irs effects on deepes tissues
were minimal. 16 Two other studies also reported that NaOCl did
not impair the healing process after being used as a hemostatic
agent in direct pulp cappingY- 18 Two clinical studies on NaOCl
as a pulpotomy agent in primary teeth have shown that it can
be used successfully as a pulpotomy medicament. 19· 20
1
Dr. Shabzendedar is an assistant professor, Dental Material Research Center; Drs.
formocresol pulpotomies performed on viral human primary molars.
Methods
Participants. Followi ng approval by the Ethics Committee of
Mashhad University of Medical Sciences, Mashhad, Iran, 100 3-
to 5-year-olds (60 males and 40 females; mean age=4.3 years old)
were selected among patients attending the clinic of rhe Pediatric
Dentistry Department of the university's School of Dentistry be-
tween January to May of 2010. Each child had at least one pri-
mary mandibular second molar with advanced caries that required
pulpotomy treatment. The children were healthy and coopera-
tive (uncooperative children during the study were excluded) . In-
formed consent was obtained from the parents of all participants
before the investigation began.
Teeth were selected for inclusion in the study according to
the following cri ceria:
1. primary molars with vital carious pulp exposures that
bled upon entering the pulp chambers;
2. no clinical symptoms or evidence of pulp degeneration,
such as a history of spontaneous and nocturnal pain, pain
on percussion, history of swelling, mobility, or sinus tracts;
3. no radiographic signs of internal or pathologic external
resorption and no furcation radiolucency;
4. teeth would be restorable with posterior stainless steel
crowns.
Periapical radiographs of the teeth were taken using the XCP
(extension cone paralleling) technique.
Interventions. The 100 children were randomly allocated to
receive one of the two pulpotomy techniques: FC (1:5 Buckley's
solution; control group); or three percent NaOCl (experimental
group). After the administration of local anesthesia, the selected

-- 2
Mazhari, and 'Talebi are associate professors, Oral & Maxillofacial Diseases Research
Center, Department of Pediatric Dentistry, Faculty of Dentistry; and 3Dr. Alami is a
prosthodontic assistant, Prosthodontic Department, School of Dentistry, all at Mashhad
University of Medical Sciences, Mashhad, Iran.
Correspond with Dr. Mazhari at mazharif@mums. ac. ir
teeth were isolated with a rubber dam. Following caries removal,
coronal access was performed using a sterile low-speed bur. A
sterile no. 6 carbide round bur was used for coronal pulp ampu-
tation, and a water-moistened cotton pellet was used to achieve
hemostasis for no more than five minutes to ensure that the pulp

SODIUM HYPOCHLORIT E AS PULPOTOMY MEDICAM ENT IN PR IMARY MO LARS 329

PEDIATRIC DENTISTRY V35 1 N04 JUL I AUG 13

was healthy. If bleeding began during placemem of the medica- respectively in the rwo studies. Considering the probability of a 20 [.

tions, rhe tooth was excluded from the study. Placed on the pulp percent dropout, a sample size of 50 in each group was planned. 111
stumps in the experimental group (N=50) and control group Randomization and blinding. Each child was randomly h
(N=50), respectively, was a cotton pellet saturated with three per- allocated to one of the rwo groups using the Research Randomizer
cent NaOCl (for 30 seconds) or a cotton pellet moistened with FC program (available at www.randomizer.org; Social Psychology Net-
(for one minute). After removing the pellet, the cavity was rinsed work, Middletown, Conn., USA). The dentists assessing the out- J
with sterile physiologic saline. In all groups, a layer of reinforced comes were blinded to group assignment, but due to the obvious
zinc oxide and eugenol (IRM, Dentsply DeTrey, Konstanz, Ger- smell of FC and the differences in the techniques, the operator
many) was placed over the dressed pulp stumps prior to restoring could not be blinded. n
the reeth with stainless steel crowns (3M ESPE, Sr. Paul, Minn., Statistical methods. Statistical analysis of the differences in gc
USA) lured with glass ionomer cement. The same operator provided treatment outcomes was performed using Fisher's exact test. We n-
rhese uearmems to all patients. used the SPSS 11.5 software (SPSS Inc, Chicago, Ill., USA) to o.
Follow-up. The children were recalled for clinical and radio- perform the analyses. The rests were conducted at a sign ificance
graphic evaluations after six and 12 months. Two experienced level of 5 percent. Cl
dentists (other than the aforementioned operator), both blinded to
the technique, evaluated the teeth clinically and radiographically. Results
The interexaminer reproducibility was good (K=0.889±0.077 SD). Treatment results for each group at each of the follow-up periods 1'

For intra-examiner reproducibility for radiographic assessment,
10 percent of the radiographs were reevaluated after rwo weeks.
The result was optimal (K=l.O) . The diagram of the participams
and teeth is shown in Figure 1.
Hypothesis and outcomes. The null hypothesis of this study
was chat the rwo treatmems (FC or NaOCl) would show no dif-
ferences in clinical and radiographical effectiveness. Teeth were
judged clinically successful if they had no pain symptoms, tender-
ness to percussion, swelling, fistula, and pathologic mobility. Teeth
were scored as radiographic successes if they showed no evidence
of inter-radicular radiolucency, internal or external root resorption,
and periapical radiolucency.
Sample size. According to rwo prior studies (Zurn and Seale21
and Vargas et al. 19 ), the sample size of 40 in each group, with 95
percent confidence and a power of 86 percent, could detect the
differences berween the rwo groups (FC and NaOCl) at the 12-
momh follow-up. The success rates were 97 percem and 76 percem,
are presented in Table 1. After one year, 45 samples from the
FC group and 36 samples from the NaOCl group were available
for reevaluation. At both the 6- and 12-month postoperative eval- 11
uations, all of the teeth were clinically successful. At the 6-month
evaluation, one tooth from the NaOCl group was radiographi-
cally assessed as a failure because of internal resorption. At the same !r
time, three teeth from the FC group were considered a failure (rwo
had internal resorption and one had external resorption). At the
12-month evaluation, three of the teeth treated with NaOCl (one
had internal resorption and two had external resorption) and
three of the teeth treated with FC (rwo had internal resorption
and one had external resorption) were considered failures.
In the NaOCl group, the tooth with internal resorption at
the 12-month recall was the same one at the 6-month recall.
None of the radiographic failures of the FC group were new. The
c

Group Evaluations
Assessed for eligibility
6 mos (%) 12 mos (%)
I (N;178)
I N N

3% Sodium hypochlorite
Excluded (N; 78) Success: 41 (98) 33 (92)
(Did not meet the
inclusion criteria)
Failure: 1 (2) 3 (8)
I :5 Formocresol
Success: 45 (94) 42 (93)
Randomization (N;1QO) Failure: 3 (6) 3 (7)
I I

----- ------
Allocated to NaOCL group
(N;SQ)
Allocated to FC group
(N;SQ)
I
P-value .62 1.00

J ~
Lost to follow-up (N;8) Lost to follow-up (N;2)
£c: 8 dropouts 2 dropouts
0
E Analyzed (N;42) Analyzed (N;48) 3% Sodium 1:5 Formocresol
J, (1 radiographic failure) (3 radiographic failure) hypochlorite

~ ~ 6 mos 12 mos 6mos 12 mos

£c: Lost to follow-up (N;14) Lost to follow-up (N;S) RR*

14 dropouts 5 dropouts
0
E IR* 1 2 2
Analyzed (N;36) Analyzed (N;45)
~ (3 radiographic failure) (3 radiographic failure) ER* 2
PR*

Figure I. Flow of participants and pulpotomized reerh up to 12 months. * RR=radicular radiol ucency; IR=inrernal rooc resorpcion;
ER=exrernal root resorp cion; PR=periapical radiolucency.

330 SODIUM HYPOCHLORITE AS PULPOTOMY MEDICAMENT IN PRIMARY MOLARS


radiographic appearance of the pulp in treated molars is described
in Table 2. No statistically significant differences were detected
between the two groups at any of the follow-up periods (P>.05).
No adverse events or side effects were identified during this study.
Discussion
The pulp of a tooth can be exposed due to several causes, includ-
ing dental caries. Caries penetration of the pulp can cause bacte-
rial invasion of the pulp, resulting in pulpal inflammation. 22•23 The
goal of vital pulp therapy is to treat reversible pulpal injury and
maintain pulp vitality and function. In pulpotomy treatment,
only the inflamed coronal pulp tissue is removed and the unaffected
radicular pulp tissue, which is able to heal, is left in situ. If suc-
cessful, this procedure precludes the need for more invasive and
expensive treatments, such as pulpectomy. Until now, differ-
ent medicaments have been investigated for use as a pulpotomy
agent. Nadin et al., however, in a Cochrane Review, reported that
there was no reliable evidence supporting which is the most ap-
propriate agent or technique for pulpally involved primary
molars. 24 Therefore, we aimed to compare the clinical and radio-
graphic success rates ofNaOCl and FC as pulpotomy agents.
The results showed that there were no significant differences
in effectiveness between the two agents after six and 12 months.
In the NaOCl group, clinical success rates were 100 percent and
radiographic success rates were approximately 98 percent and 92
percent at the 6- and 12-month recalls, respectively.
Our findings are different from those reported by Vargas et
al. Their prospective, randomized, clinical study compared the
effectiveness of five percent NaOC1 with that of ferric sulfate as
a pulpotomy medicament in decayed primary rriolars. At six and
12 months follow-up, Na0C1 showed 91 percent and 79 percent
radiographic success rates, respectively. The clinical success rates
at the two follow-up periods were 100 percent. The authors con-
cluded that NaOCl can be used successfully as a pulpotomy med-
icament. 19 Vosratek et al. have also reported a lower success rare
(clinical and radiographic success rates were 95 percent and 82
percent respectively) than what was recorded in the present study10 •
Merhodologic differences, however, such as age range, diversity in
tooth type, design of study, sample size, and using a higher con-
centration of NaOCl (five percent) in the two latter studies could
explain the difference in results with the present study.
A suitable dressing agent for exposed vital pulp should be
bactericidal, biocompatible, and reasonably priced. 25 Being hemo-
static, however, will also help achieve the goal of a bacteriometic
seal. 13 After initial hemostasis, using a sterile cotton pellet, it is
important to remove the blood clot from the pulpotomy site, as
it can be a medium for bacterial growth.
After amputating the coronal pulp, bacteria may remain in
the pulp stumps. Studies have shown that, in vital pulp therapy,
the pulp is more likely to respond with an inflammatory reaction
in case of bacterial contamination. If an antibacterial agent is
used, even in cases of existing bacteria, there is a higher probability
that rhe treatment will be successful.2 6 Biological data show that
dental pulp has an inherent capacity to heal in the absence of
bacterial infection. 27
It seems that NaOCl has all of the aforementioned charac-
teristics 'in concentrations of 2.5 percent to 5.25 percent, in addi-
tion to being ideal for hemostasis when placed on an exposed
pulp. NaOCl also provides disinfection, chemical amputation of
the blood clot, and fibrin. Furthermore, it can be used for re-
moval of residual microbial flora, which can be a major deterrent
in healing exposed pulp. 13
NaOCl has been used in dentistry for a long time. Histo-
logical studies have shown that NaOCl does not impair the cellular
healing of exposed pulps and dentin bridge formation 28 -29 and has
PEDIATRIC DE NTISTRY V 35 I NO 4 JUL I AUG 13
only superficial effects on vital pulp tissue. 16 A study by Hafez et
al. showed that primate pulps treated with three percent NaOCl
showed no evidence of pulpal necrosis at seven or 27 days. 14 The
authors concluded that three percent NaOCl is biocompatible as
a hemorrhage control agent. Tunc et al. eyaluated the effect of
three percent NaOCl (for 30 seconds) to control hemorrhage in
calcium hydroxide pulpotomies of primary teeth. 30 They reponed
that the use of three percent NaOCl as a hemostatic agent had
no effect on the outcome of calcium hydroxide pulpotomies.
In another study, Hafez et al. supported the use of NaOCl
for disinfection and chemical amputation of a clot before placing
a pulpotomy agent. 15 A recent in vitro study reponed that the
use of 0.04 percent NaOCl did not affect the viability of cells,
even in 15-minute time intervals. 31 In addition to all of the afore-
mentioned properties, NaOCl is also an inexpensive agent, which
is important when choosing an agent for pulpotomy.
In this study, FC was selected as the control pulpotomy
medicament for two reasons:
1. It is still considered to be the standard therapeutic agent
for pulpotomy treatment in primary teeth.
2. Thus far, it has been compared with many agents or
techniques, such as mineral trioxide aggregate, 32 ferric
sulphate, 33 enamel matrix derivative, 34 calcium hydrox-
ide,35 lasers, 10 and electrosurgical pulpotomy. 9
Although the standard technique is using formocresol for
five minutes, the 5-minute application time has been determined
somewhat arbitrarily. 36 Some studies have shown that a 1-minute
application rime is sufficient.3.3 7 Therefore, due to the potential
side effects of formocresol, it was decided ro apply it for a lesser
duration of time (one minute). The radiographic success rate of
93.3 percent found in the present srudy is comparable to the radio-
graphic success rates that have been previously reported (5-minutes
application of formocresol). 38.39
There were seve-ral limitations in this study. First, its design
was not "split mouth." When this study was to begin, several
investigations were simultaneously being done on teeth needing
pulpotomy treatment at rhe Department of Pediatric Dentistry,
School of Dentistry, Mashhad University of Medical Sciences.
Therefore, it was difficult to find children with at least two pri-
mary mandibular second molars requiring pulporomy. As a result,
children with at least one tooth requiring pulpotomy treatment
were considered to be eligible. Another limitation was rhar the
dropout rate was fairly high [14 patients (28 percent) in rhe
NaOCl group and five patients (10 percent) in the FC group at
the 12-month recall]. Usually, dental patients seek treatment when
they are in pain. Hence, after completion of treatment, when pa-
tients do not have any dental problems, some of them do not
come back for recall appointments, despite repeated calls.
Concl usions
Based on this study's results, the following conclusions can be
made:
l. There were no statistically significant differences at 12
months follow-up between primary molar pulpotomies
performed with diluted (1:5) formocresol and three per-
cent sodium hypochlorite.
2. Furrher clinical studies with long-term follow-ups are
needed, however, to test the efficacy of NaOCl as a
pulpotomy medicament in primary teeth.
Acknowledgment
This research was supported by the vice chancellor for research,
Mashhad University of Medical Sciences, Mashhad, Iran.
SODI UM HYPOCHLORITE AS PULPOTOMY MEDICAM ENT IN PRIMARY MOLARS 33 1