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Year : 2018  |  Volume : 21  |  Issue : 5  |  Page : 546-550
Assessment of pain and dissolution of apically extruded sealers and their effect on the periradicular tissues

1 Department of Conservative Dentistry and Endodontics, Institute of Dental Sciences, Siksha ‘O’ Anusandhan Deemed to be University, Bhubaneswar, Odisha, India
2 Private Practitioners, Bhubaneswar, Odisha, India

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Date of Submission24-May-2018
Date of Decision15-Jun-2018
Date of Acceptance17-Jul-2018
Date of Web Publication17-Sep-2018


Aim: This study aimed to evaluate the intensity of pain after unintentional extrusion of resin-based and calcium hydroxide (Ca[OH]2)-based endodontic sealers as well as their influence on the periradicular tissues.
Materials and Methods: A total of 120 single-rooted teeth exhibiting extrusion of sealer in the postoperative radiographs were included in the study. According to the sealers used, the teeth were divided into four groups (n = 30): Group I – AH Plus®, Group II – Resino Seal, Group III – Sealapex™, and Group IV – Apexit® Plus. Postoperative pain was assessed at 0–6 h, 6–12 h, 12–24 h, and 24–48 h of obturation using Visual Analog Scale. Radiographs were taken at 3, 6, and ≥9 months to 1-year follow-up and compared with baseline radiographs to assess the dissolution of extruded sealers and healing of periradicular tissues.
Statistical Analysis: ANOVA, Kruskal–Wallis, and Pearson's Chi-square test were used. Statistical significance level was set at P ≤ 0.05.
Results: Postoperative pain intensity was higher in case of AH Plus® sealer followed by Sealapex™ up to 12 h of obturation and was statistically nonsignificant. Apexit® Plus at all time intervals showed statistically significant less pain intensity than AH Plus® and Sealapex™ but not from Resino Seal group. At 9-month follow-up, better healing of periradicular tissues was shown by AH Plus® (48.1%) followed by Apexit® Plus (44.4%) and Sealapex™ (41.2%) with statistically nonsignificant difference.
Conclusion: In case of periapical extrusion, both resin-based and Ca(OH)2-based sealers caused postoperative pain. Both Ca(OH)2- and resin-based sealers did not influence the treatment outcome.

Keywords: Pain assessment; periradicular tissue healing; sealer dissolution; sealer extrusion; Visual Analog Scale

How to cite this article:
Shashirekha G, Jena A, Pattanaik S, Rath J. Assessment of pain and dissolution of apically extruded sealers and their effect on the periradicular tissues. J Conserv Dent 2018;21:546-50

How to cite this URL:
Shashirekha G, Jena A, Pattanaik S, Rath J. Assessment of pain and dissolution of apically extruded sealers and their effect on the periradicular tissues. J Conserv Dent [serial online] 2018 [cited 2022 Jun 29];21:546-50. Available from:

   Introduction Top

Root canal obturation prevents channel of fluids from the periradicular tissues into the canal as well as microorganisms and their virulent by-products from the canal to the periradicular tissues.[1] Canal irregularities, accessory canals, discrepancies between the filling materials, and the canal walls are expected to be filled by the sealer. Ideally, the obturating material should reach to the apex of the tooth without percolating into the periradicular tissues.[2],[3] However, in some scenarios, it is difficult to control the flow of sealer into the periradicular tissues as well as into the surrounding anatomical structures. Once the filling material extrudes, either it solubilizes in the tissue fluids or gets phagocytosed.[4] According to guidelines approved by Comitato Intersocietario Coordinamento delle Associazioni Odontostomatologiche Italiane in the year 2003, extrusion of small amount of endodontic filling materials beyond the root apex could be acceptable if it does not cause insult to vitally important structures such as maxillary sinus and inferior alveolar nerves.[5] Pain is a common complication due to extrusion of sealer. Pain cannot be quantified; hence, various pain-measuring scales such as Visual Analog Scale (VAS), Wong–Baker Faces pain scale, Descriptor Differential Scale, and McGill Pain questionnaire have been used clinically.

The aim of the present study was to assess the postoperative pain (VAS) and dissolution of four apically extruded sealers (AH Plus ®, Sealapex™, Resino Seal, and Apexit ® Plus) with their influence on periradicular tissues.

   Materials and Methods Top

This study was undertaken after ethical clearance from the Institutional Review Board. Informed consent was obtained from all patients. Inclusion criteria were single-rooted teeth with either exhibiting apical periodontitis which was radiographically determined or exhibiting symptoms of irreversible pulpitis or tooth with attrition requiring endodontic treatment. Exclusion criteria were teeth with open apex, crack, or fracture lines; periapical abscess or cyst; diabetic patients; weeping canals; and patients requiring antibiotic premedication. Based on clinical signs, symptoms, and periapical radiographs, teeth were diagnosed as “vital” or “necrotic.”

In general, of all single-rooted root canal-treated teeth (n = 673) from 524 patients over a period of 2 years, teeth exhibiting overextrusion of sealer in the postobturation radiographs (n = 120) from 93 patients with follow-up examination up to 1 year were selected for analysis of the present study. The procedure followed was as follows: all the teeth were cleaned using rubber cup and pumice prophylaxis. Standard protocol for administration of local anesthesia was done (2% lignocaine and adrenaline 1:200,000; Lox, Neon Laboratories, Mumbai, India) followed by rubber dam isolation (Hygenic Dental Dam, Coltene Whaledent Inc., Germany) and field disinfection with 30% H2O2 (Alpha Chemika, Mumbai, India) and 5% tincture of iodine (Rougier Pharma, USA). Coronal flaring was done with Gates Glidden burs (Mani Inc., Japan) and apical patency was checked with #15 K-file (Mani Inc., Japan). Working length was established using apex locator (Propex Pixi, Dentsply Maillefer, Switzerland) and radiographs. Crown-down preparation was done using different rotary systems (Protaper Universal, Dentsply Maillefer, Switzerland, and Hero Shaper, Micro Mega, France). Care was taken in all cases to avoid overinstrumentation. Irrigation protocol was 2 ml of 3% NaOCl (Prime Dental, India) in between instrumentation followed by final irrigation with 2 ml 17% ethylenediaminetetraacetic acid (Prevest Denpro, India) and final rinse was done with 5 ml of distilled water. This protocol was followed after understanding the interactions, advantages, and limitations of the irrigants used.[6]

Two resin-based sealers, AH Plus ® (Dentsply Maillefer, Switzerland) and Resino Seal (Amrith Chemicals and Mineral Agency, India), and two calcium hydroxide (Ca[OH]2)-based sealers, Sealapex™ (Sybron Endo, USA) and Apexit ® Plus (Ivoclar Vivadent, Liechtenstein), were taken for the study. Teeth with a diagnosis of vital pulp were treated in a single visit, whereas teeth with necrotic pulp were treated in two visits with an interappointment medication with Ca(OH)2 (Avue Cal, Dental Avenue, India) for 2 weeks. For obturation, warm vertical compaction technique was followed. Access restoration was done with glass ionomer cement (3M ESPE, USA). Postoperative periapical radiographs were taken immediately after completion of endodontic treatment (baseline). Samples were divided into four groups according to the sealers used: Group I – AH Plus ®, Group II – Resino Seal, Group III –Sealapex™, and Group IV – Apexit ® Plus. Pain assessment was done for 0–6, 6–12, 12–24, and 24–48 h following root canal treatment using 100-mm VAS. Pain scoring was as follows: none (0–4 mm), mild (5–44 mm), moderate (45–74 mm), or severe (75–100 mm). Patients experiencing severe pain were instructed to take analgesics (Zerodol-SP, Ipca Laboratories Ltd, Mumbai, India; paracetamol 325 mg, aceclofenac 100 mg, and serratiopeptidase 15 mg) orally. Patients' follow-up was done after 3, 6, and ≥9 months to 1 year of endodontic treatment.


At each follow-up session, one periapical radiograph was taken in straight projection for all the cases. The radiographs were scanned using CanoScan 9950F scanner (Canon Inc, Melville, New York, U.S.A.) and images were saved at 650 dots per inch using Canon Utility software 16.0.5 version (Canon Inc, U.S.A.) for further analysis by endodontist blind to the procedures. The evidence of sealer dissolution in radiographs compared to the baseline radiographs was denoted as “present” or “absent.” When both the contour and width of the periodontal ligament space were normal or slightly widened along with the surrounding normal bone, it was categorized as “healed.” Radiographs those showed reduction in the size of periapical lesion compared to the baseline radiographs were categorized as “healing.” Those presented definitive apical radiolucency without any change compared to baseline were categorized as “nonhealed.”[4]

   Results Top

Comparative periapical sealer dissolution for different groups at different time intervals is illustrated in [Figure 1]. The mean VAS score at different time intervals was calculated using ANOVA [Table 1] and Kruskal–Wallis test for intergroup comparison [Table 2]. For comparing the presence/absence of different sealers along with periradicular healing, Pearson's Chi-square test was performed [Table 3].
Figure 1: Representation of sealer dissolution. (a-c) Depicts AH Plus; (d-f) Resino Seal; (g-i) Sealapex; (j-l)- Apexit Plus (3 months, 6 months, >9 months–1 year follow up respectively)

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Table 1: Mean and standard deviation of Visual Analog Scale score at different time intervals for all groups using ANOVA

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Table 2: Intergroup comparison of pain at different time intervals using Kruskal-Wallis test

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Table 3: Influence of extruded endodontic sealers on the periradicular tissues at different time intervals

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AH Plus ® group proved to have better periapical healing capacity, i.e., 48.1% (healed) and 40.7% (healing) with only 11.1% nonhealed cases during 9 months to 1-year follow-up. Following that 44.4% and 41.2% of healed cases were shown by Apexit ® Plus and Sealapex™ groups, respectively. Resino Seal showed to have the least healing capacity (41.2%) (nonhealed) during ≥9 months to 1-year follow-up as compared to 6-month follow-up (15.4%). Periapical sealer presence was maximum in AH Plus ® group (81.5%), whereas complete dissolution was shown by Sealapex™ group (35.3%).

   Discussion Top

In this in vivo study, the intensity of pain had been evaluated after the extrusion of different endodontic sealers along with their fate and influence on periradicular tissues. Huang et al. stated that biocompatibility facilitates stimulation of the damaged apical tissue reorganization which is in direct contact with the material.[7] Freshly mixed sealers possess toxicity which however reduces on setting of the sealer.

Among all the sealers, AH Plus ® was associated with the highest pain intensity post 12 h evaluation. This signifies the increased toxic effect of AH Plus ® sealer followed by Sealapex™, Resino Seal, and Apexit ® Plus. AH Plus ® contains both epoxy resins and amines which have toxic effect. The unpolymerized residues remain due to formation of oxygen inhibition layer in the mixture of AH Plus ® sealer which is responsible for maintaining its toxic effect.[8] Increase in cytotoxicity as time progressed might be due to the volatilization of formaldehyde during the hot incubation or setting process of the AH Plus ® sealer.[9] Results of our study are concurrent with those of earlier studies which show increased cytotoxic effect of AH Plus ® Sealer.[10] In Sealapex™ group, severe pain was experienced by three patients at 6 h and five patients at 12 h interval. This can be correlated to its cytotoxic potential. Sealapex™ after setting becomes unstable and disintegrated.[11] Its cytotoxicity is due to components such as isobutyl salicylates and polymethylene methyl salicylate resin [12] and Ca(OH)2 itself because of its high pH.[12] Earlier studies have shown that Sealapex™ has longer setting time [13] and has proved to be cytotoxic even after 1, 7, and 14 days of evaluation.[10]

Resino Seal also showed cytotoxic effect as 13 cases had pain, of which 1 was severe in intensity during the initial 6 h period and rest were of moderate or mild intensity. Between 6 and 12 h, pain was of moderate and mild type. This indicates the toxic effect of Resino Seal sealer which could be due to the presence of methanamine which releases some amount of formaldehyde during setting process.[14] Another reason is the presence of epoxy resin in the sealer. In Apexit ® Plus group, the presence of Ca(OH)2 and disalicylate in Apexit ® Plus sealer could contribute to its cytotoxicity resulting in pain.[15] The inflammatory response may be severe in cases of overextrusion, but this response has short-term effect.[16] Lowest pain intensity was observed in this group. As time progresses, most of the sealers lose their inflammatory or irritating components and became relatively inert.[17] Similar observations were seen in our study too.

At 3-month follow-up, none of the groups showed complete dissolution of sealer. At >9 months to 1-year follow-up, complete dissolution of sealer was in the following order: Sealapex™ >Apexit ® Plus >Resino Seal >AH Plus ®. The thixotropic nature of AH Plus ® transforms its internal structure allowing change in the flow speed,[18] and therefore lower removal rate of AH Plus ® sealer.

When the sealer gets extruded in the periradicular region, chemical mediators of inflammation affect the nerve fibers causing pain. Sealer particles gets phagocytosed by the macrophages, transporting them to the site of inflammatory reaction. In due course of time, the sealer is completely removed creating a space which eventually promotes healing, subsiding the symptoms of pain and inflammation.[19] This space allows the ingrowth of connective tissue with formation of cementum layer (sometimes), narrowing the canal lumen and foramen.[20] On the other hand, this space created could be disadvantageous as fluid seepage and bacterial regrowth may occur leading to recurrent infection.[21] Although AH plus showed higher pain intensity and low removal rate from the periradicular tissues, it was associated with the significantly better healing as compared to the other sealers used in the present study. The reason for better healing property of AH Plus ® sealer could be the low solubility of AH Plus ® sealer which contributes to its maintained antibacterial action and local tissue repair. AH Plus ® has been shown to be excellent in repairing the periradicular tissue where apposition of mineralized tissue was evident histologically in the root canal walls of periapical region.[22]

Apexit ® Plus and Sealapex™ showed comparatively less healing than AH Plus ® sealer. Ca(OH)2 has been known for its antibacterial and tissue-regenerating capacity. This ability of Ca(OH)2 is achieved on leaching of calcium and hydroxyl ions into the surrounding tissues. Due to this property, Ca(OH)2-based sealers exhibit a satisfactory effect with the surrounding tissues thereby assisting in healing.[10] However, for Ca(OH)2-based sealers to be an efficient antibacterial agent, they should maintain a high pH (≥12.5), but as the sealer sets, the pH drops resulting in decreasing antibacterial property and loss of effectiveness.[23]

Significant reduction was seen in periapical index score for Apexit ® Plus and AH Plus ® sealers at >9month-12 month interval, with both the sealers showing 90% success rate.[15] Periradicular healing with minimal areas of inflammation was observed when teeth were obturated using Sealapex™. Along with this, significant bone formation, cemental deposition, and periodontal fiber organization have been noticed.[16] In our study, minimal amount of healing was seen in Resino Seal group as compared to other sealers. Since no studies have been conducted using Resino Seal, further studies evaluating its properties need to be investigated.

The absence of sealer does not mean it gets completely dissolved into the periradicular region. It might have happened that the density or volume of the remaining sealer was so minimal which could not be detected radiographically because of the bidimensional nature of radiographs and can be confirmed histologically. If all the 93 patients could have been evaluated for the complete follow-up time, the result obtained could have been more appropriate.

   Conclusion Top

Under the limitations of the study, it was concluded that postoperative pain was higher in case of AH Plus ® sealer and least for Apexit ® Plus. Complete dissolution of sealer from periapical region was not seen in any of the tested groups. Faster removal was seen for Ca(OH)2-based sealers as compared to resin sealers. All the sealers resulted in significant healing, but due to low solubility and long term antibacterial action, AH Plus ® showed better results as compared to other groups.

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Conflicts of interest

There are no conflicts of interest.

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Correspondence Address:
Amit Jena
Department of Conservative Dentistry and Endodontics, Institute of Dental Sciences, Siksha ‘O’ Anusandhan Deemed to be University, Bhubaneswar - 751 003, Odisha
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/JCD.JCD_224_18

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