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Year : 2019  |  Volume : 37  |  Issue : 2  |  Page : 198-204

A histopathological comparison of pulpal response to formocresol and sodium hypochlorite used as pulpotomy medicaments: In primary teeth – A clinical trialA histopathological comparison of pulpal response to formocresol and sodium hypochlorite used as pulpotomy medicaments: In primary teeth – A clinical trial

Department of Pedodontics and Preventive Dentistry, Mamata Dental College, Khammam, Telangana, India

Date of Web Publication26-Jun-2019

Correspondence Address:
Dr. Srikanth Reddy Kola
Department of Pedodontics and Preventive Dentistry, Mamata Dental College, Khammam, Telangana
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/1319-2442.261333

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Aim: The aim of the study was to evaluate and compare formocresol (FC) and 5% Sodium hypochlorite (NaOCl) as pulpotomy medicaments and to assess the histological features of both pulpotomy medicaments in primary teeth. Materials and Methods: In the present study, pulpotomies were performed on 60 primary molars in 55 children aged 5–8 years. The teeth were divided into two groups NaOCl and FC were placed on the canal orifices, respectively, and crowns were restored with intermediate restorative material and glass ionomer cement. The teeth were underwent a histopathological procedure and extracted after 6 months. The Histological samples were evaluated in relation to odontoblastic integrity, pulp calcification, dentin bridge formation, and presence of pulp stone. Results: No statistically significant difference was found between the two groups with respect to inflammatory response, soft-tissue organization, and dentin bridge formation (P > 0.005). Conclusion: Based on the results of this study Sodium hypochlorite may be a suitable medicament for conducting pulpotomy in primary teeth.

Keywords: Formocresol, Sodium hypochlorite, Pulpotomy, Primary molars, Histological evaluations

How to cite this article:
Kola SR, Reddy N V, Sneha T, Reddy M A, Niharika P, Kumar P J. A histopathological comparison of pulpal response to formocresol and sodium hypochlorite used as pulpotomy medicaments: In primary teeth – A clinical trialA histopathological comparison of pulpal response to formocresol and sodium hypochlorite used as pulpotomy medicaments: In primary teeth – A clinical trial. J Indian Soc Pedod Prev Dent 2019;37:198-204

How to cite this URL:
Kola SR, Reddy N V, Sneha T, Reddy M A, Niharika P, Kumar P J. A histopathological comparison of pulpal response to formocresol and sodium hypochlorite used as pulpotomy medicaments: In primary teeth – A clinical trialA histopathological comparison of pulpal response to formocresol and sodium hypochlorite used as pulpotomy medicaments: In primary teeth – A clinical trial. J Indian Soc Pedod Prev Dent [serial online] 2019 [cited 2020 Jul 15];37:198-204. Available from: http://www.jisppd.com/text.asp?2019/37/2/198/261333

   Introduction Top

Pulpotomy is the most common pulp treatment of the caries involved primary teeth in children before 6 years of age,[1],[2] it is indicated in primary molars when the radicular pulp tissue is capable of healing after surgical amputation of the affected or infected coronal pulp.[3] This treatment has attained acceptance clinically and radiologically when pulpal inflammation is confined to the coronal pulp.[4] The importance lies not only with the choice of the procedure but also with the different pharmacotherapeutics agents which have been already used.[5] The procedure involves coronal pulp amputation, and the remaining vital radicular tissue surface is treated with long-term clinically evaluated medicaments to preserve the vitality and function of radicular pulp.[6]

The pioneering medicament used for pulpotomy was formocresol (FC) [Figure 1] a mixture of formaldehyde and cresol,[7] it was first introduced by Sweet in the 1930,[8] owing to its bactericidal and tissue fixative properties. Since then, FC pulpotomy technique has been practiced widely world over, and a sizable literature is available on its different aspects.[7] The overall clinical success rate of more than 90% is reported for FC although histologically, it is less and variable. There are histological evidence in animals and humans showing that FC initiates devitalization process in the remaining radicular tissue.[9],[10] Along with this fact, concern about safety haunted this material persistently for the past three decades.[11],[12]
Figure 1: Formocresol: Sultan Health care; Inc., (New york, USA)

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However, several studies have reported its potential for the local/systemic side effects, i.e., local inflammation/necrosis, general cytotoxicity, mutagenic/carcinogenic effect, systemic disturbances, and immunologic responses.[13] Concern has been expressed about the effect of FC on the enamel structure of the permanent successors.[14]

Aside from these suggested materials, sodium hypochlorite (NaOCl) [Figure 2] seems to be a suitable alternative for FC. Used for over four decades[15] as the most popular endodontic irrigant available, it has been shown to be a very good antimicrobial[16] and hemostatic agent[17] two important factors in primary teeth pulpotomy, as well as a pulpotomy medicament. The clinical and radiological success rates of NaOCl pulpotomy were reported to be 100% and 76%, respectively.[18]
Figure 2: NaOCl; Vishal dental care Pvt., Ltd. (Gujarat, India)

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When considering the detrimental effects of FC and suitable properties of NaOCl, it may be wise to perform the pulpotomy of primary teeth with NaOCl. Therefore, the purpose of thisin vivo study was to evaluate pulp status after pulpotomy with NaOCl and FC.

   Materials and Methods Top

In the present study, 60 primary molars from 55 children who attended the Department of Pedodontics and Preventive dentistry, Mamata Dental College and Hospital, Khammam with good general health and no history of systemic illness or hospitalization were selected. Written informed consent was obtained from the parents or guardians of children. The protocol was approved by institutional human ethical committee.

Teeth requiring pulpotomy treatment which met the clinical and radiographic criteria were selected randomly from children aged between 5 and 8 years and were divided into two groups: FC and NaOCl groups allocating 30 teeth in each group. Further, from each group, 10 teeth were subjected to histological evaluation.

The clinical criteria for tooth selection were the following:

The following are the inclusion criteria for the tooth selection (1) teeth with deep carious lesion (radiographically, the caries should be approximating to the pulp), (2) tooth should be vital with healthy periodontium, (3) pain if present should neither be spontaneous nor persistent (4) absence of clinical signs or symptoms suggesting a nonvital tooth such as suppurating sinus, soft-tissue swelling, mobility, or tenderness to percussion, (5) tooth should be restorable after the pulpotomy, (6) hemorrhage should stop within 5 min from the amputated pulp stumps using a sterile pledget of moist cotton, (7) children who were to go for serial extraction procedure, and (8) antibiotics should not be received by the patient at least 1 week before the treatment.

The following were the exclusion criteria for the study: (1) evidence of internal resorption, (2) presence of any interradicular bone loss, (3) existence of abscess or fistula in relation to the tooth, (4) radiographic signs of calcific globules seen in pulp chamber, (5) caries penetrating to the floor of the pulp chamber, and (6) tooth close to normal exfoliation.[19],[20]


The pulpotomy procedure was performed on the lower primary canine's, primary first molar and second molar for accessibility and accuracy. The tooth was anesthetized with 2% lidocaine, 1:80,000 adrenaline and rubber dam isolation obtained. Soft debris, caries, and unsupported enamel and dentin were removed with spoon excavator before opening the pulp chamber. Caries removal and coronal access were made using a no ≠ 245 bur (DENTSPLY, USA) in a high-speed handpiece. The coronal pulp was removed with a small sharp spoon excavator. Pulp chamber was then irrigated with saline to remove all debris. Hemostasis was obtained with a moistened cotton pellet gently pressed against the amputated pulp stumps in both the groups.

Formocresol group

The FC pulpotomy group was designated as the control group; the pulpotomy treatment was carried out using FC solution (1:5) (Sultan health care, Inc., USA). The excess amount of FC from the cotton pellets was impregnated into a sterile cotton pellet onto the FC impregnated cotton pellet. The FC pellet remained in the canals for 5 min, after which the cotton pellet was removed from the cavity, and it was confirmed that the bleeding had stopped and the pulp tissue had turned brown. Intermediate restorative material (IRM) (DENTSPLY) was then placed on the root pulp, the cavity was closed with glass ionomer cement (DENTSPLY), and the tooth was restored with a stainless steel crown (3M ESPE, St. Paul, USA).

Sodium hypochlorite group

In NaOCl (Vishal Company, India) group, cotton pellet soaked with 5% NaOCl was placed on coronal pulp stumps for 30 sec, fill the chamber with IRM (DENTSPLY) and condense. The tooth was restored with a stainless steel crown (3M ESPE).

In all the groups, teeth were restored with stainless steel crowns after 1 week. All the teeth were evaluated at 3 months' and 6 months' intervals for the clinical and radiological symptoms. The children were examined at follow-up clinically for the signs and symptoms such as pain, swelling, and sinus/fistula, and radiographically for periapical changes, furcation radiolucency and internal root resorption, but with no clinically symptoms, were monitored but not removed.

Histological preparation

Following postoperative interval of 6 months, the teeth were extracted and subjected to histological examination. The extracted teeth were injected with formalin from the apical foramen with injected with formalin from the apical foramen with minimum pressure and stored in formalin for overnight fixation. Decalcification was obtained using 5% HCL + 5% HNO3 for 2–4 weeks. Subsequently, the tooth was embedded in paraffin wax, and 5 μm sections were obtained and stained with hematoxylin and eosin. The observer evaluating the histologic section was blinded to all the procedure involved.

Histological evaluations were made under a light microscope (Carl Zeiss) Oberkachen, Germany at × 400 magnification based on the criteria previously established.

Statistical analysis

All data were entered into MS Excel sheet and analyzed by Microsoft Excel software (SPSS-17.0, SPSS Inc., Chicago, Illinois, USA) to assess the success rate of the treatment with FC, NaOCl, After 3, 6 months. The difference between the effects of the two materials was statistically analyzed by Fisher's exact test. P < 0.005 was considered statically significant.

   Results Top

[Table 1] represents samples for available for follow-up giving a total sum of 25 (FC group) and 26 (NaOCl group) subjects at 6 months' interval. The sample loss was 16.6% for FC group. 13.3% in NaOCl group at the end of 6 months' interval.
Table 1: Participants available for follow-up

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[Table 2] presents the frequency % of clinical success rate of FC, NaOCl was 88%, 96.3% subjects at 3 months', 6 months' interval. With no statistical differences between them based on the results of Fisher's exact test (P = 0021).
Table 2: Number of drop outs

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[Table 3] presents the frequency % of the radiological success rate of FC; NaOCl was 72%, 88.4% at 3 months', 6 months' interval. With no statistically differences between them based on the results of Fisher's exact test (P = 0.055).
Table 3: Results of histological evaluation between FC vs NaOCl

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The results of the histological evaluation of samples obtained are listed in [Table 4]. A total of 20 teeth were subjected to histological evaluation, with 10 teeth in each group. The parameters and scoring criteria were according to systemic proposed by Cox et al. 1996.[21]
Table 4: Histological success rates between FC vs NaOCl groups at 3 m and 6 months interval

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[Table 4] presents the frequency % of histological success at 3 months', 6 months' interval were 53.9%, 55.4%, respectively, with no statistical differences between them based on the results of Fisher's exact test (P = 0.454).

Histological evaluation

The Histological evaluation shows no Dentin bridge formation in FC group at 3 months, 6 months time intervals [Figure 3]a, [Figure 3]b, [Figure 3]c, [Figure 3]d. While in NaOCl group the dentin bridge formation was continuous and thick, well defined odontoblastic layer surrounding the pulp chamber at 3 months and 6 months intervals [Figure 4]b.
Figure 3: Histological feature of formocresol group. (a) Photograph at × 40 magnification shows Area of mild necrosis in radicular pulp at 3 months. (b) Photograph at × 40 magnification area of mild chronic inflammatory cell Infiltrate predominantly composed of lymphocyte in radicular pulp at 3 months. (c) Pulp calcification are found as isolated discrete masses in radicular pulp at 6 months. (d) Chronic inflammatory cell infiltrate composed predominantly. Of lymphocyte in radicular pulp at 6 months. (e) Photomicrograph at × 40 magnification showing chronic, minimal inflammatory cell infiltrate composed predominantly of lymphocytes at 6 months

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Figure 4: Histological feature of sodium hypochlorite group. (a) Photomicrograph × 40 magnification shows area mild chronic inflammatory cell infiltrate predominantly composed of lymphocytes and necrosis dilated blood vessels at 3 months. (b) Photomicrograph × 40 magnification area of mild necrosis in radicular pulp at 3 months. (c) Photomicrograph at × 40 magnification chronic minimal inflammatory cell infiltrate composed predominantly of lymphocyte at 6 months. (d) Photograph at × 40 magnification dentin bridge formation between NAOCl and pulp chamber with intact odontoblast layer and no inflammatory cells at 6 months

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Regarding the inflammatory cell infiltrate, all two groups [Figure 3]b and [Figure 4]a, [Figure 4]c showed chronic, diffuse, minimal chronic inflammatory cell infiltrate predominantly of lymphocytes (Grade 2) in specimens extracted after 3 months. After 6 months, specimens in FC group continued to show chronic diffuse, minimal inflammatory cell infiltrates [Figure 3]d and [Figure 3]e whereas specimens of NaOCl group [Figure 4]d showed normal pulp tissue with presence of abundant collagen bundles and fibroblasts adjacent to odontoblast layer.

One of the specimens each from FC which was extracted after 6 months showed single pulpal calcification in the center of the radicular pulp [Figure 3]c.

   Discussion Top

When the pulp tissue from primary teeth, observed clinically successful after pulp therapy, were evaluated histologically the number of samples classed as successful did reduce.[22] Since the best criteria for judging the effectiveness of a medicament when used for vital pulp therapy is the response it produces in the pulp, the present study evaluated the efficacy of NaOCl as a pulpotomy agent in human primary teeth through the histopathologic evaluation of pulpal response. It was compared with FC, taking into account that FC is still considered the Gold standard in primary tooth pulpotomy and the tissue reactions of the dental pulp to FC were well examined histologically in many studies.[23],[24]

The purpose of this histopathologic study was to evaluate the effect of NaOCl as well as FC on the pulp. With respect to the histopathological evaluation, the samples in FC group revealed mild areas of necrosis of radicular pulp at 3 months which is in support to Berger JE (1972) who reported a complete loss of vitality with fibrous granulation tissue in the apical part of the radicular pulp.[25] None of the samples were observed for the formation of dentin bridge as reported by Fuks AB et al. (2008)[26] Sarkar (2005) and after 2 months, 6 months, and 9 months, respectively.[27] In accordance to the study conducted by Srinivasan and Jayanthi we could notice the presence of single, isolated pulpal calcifications in center of the pulp in one sample of FC group which is due to excessive odontoblastic activity.[28]

Mild-to-moderate inflammation (grade 2) was observed in almost all the samples which is in accordance to the previous studies.[29],[30],[31] Ranly also reported that treatment of pulp with FC leaves the pulp chronically inflamed and susceptible to abscess formation.[31] NaOCl has been suggested to remove the coagulum, control hemorrhage, remove dentin chips, and aid formation of dentin bridge.[32]

Hafez et al. have performed two histological studies and reported NaOCl to be biologically compatible with exposed pulp tissue when used as a hemostatic agent in direct pulp capping.[33],[34] Rosenfeld et al. demonstrated that using 5% NaOCl had superficial effects on pulpal tissue, and its effects on deeper tissues were minimal.[35] Two other studies also reported that NaOCl did not impair the healing process after being used as a hemostatic agent in direct pulp capping.[36],[37] Two clinical studies on NaOCl as a pulpotomy agent in primary teeth have shown that it can be used successfully as a pulpotomy medicament.[38],[39]

Cox et al. reported that hemostasis is best achieved with Naocl.[40] Chompu-Inwai et al. reported a similar success rate of NaOCl/RMGIC when compared to FC/ZOE in their 3 months' evaluation.[41] Vargas et al. showed promising results from a pilot study using 5% NaOCl as a primary molar pulpotomy agent.[38] Various studies have shown a good success rate with NaOCl as pulpotomy agent ranging from 82% to 100%.[42],[43] Histologically, Haghgoo and Abbasi noted mild inflammation and also dentin bridge formation after 2 months following NaOCl pulpotomy.[44]

Our results of the present study showed that severe inflammation in FC is more than NaOCl. NaOCl can induce hemostasis and control the hemorrhage, and therefore, this may decrease the potential for inflammation following pulpotomy. Three teeth in the FC group resulted in pulpal necrosis; however, one case was seen in the NaOCl group. FC devitalizes the pulp, and this phenomenon can induce necrosis.

   Conclusion Top

Based on this study's results, the following conclusions can be made.

NaOCl has therapeutic properties that facilitate pulp healing (1) provides hemostasis, (2) provides debridement of necrotic tissue, (3) delivers antisepsis to the surgical site, and (4) does not result in prolonged cytotoxicity to the remaining dental pulp.

The use of NaOCl for wound healing and revascularization and preparing the vital pulp for pulpotomy indicates that NaOCl has a history of success in both medicine and dentistry.


As this study was only performed 60 teeth, we suggest a more extensive study to be performed with greater clinical, radiographic, and histopathological studies with long-term follow-ups are needed, however, to test the efficacy of NaOCl as a pulpotomy medicament in primary teeth.

Financial support and sponsorship


Conflicts of interest

There are no conflicts of interest.

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  [Figure 1], [Figure 2], [Figure 3], [Figure 4]

  [Table 1], [Table 2], [Table 3], [Table 4]


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