Comparative Evaluation of Postoperative Pain Following Unintentional Periapical Extrusion of Three Root Canal Sealers: A Prospective Clinical Study

Int. Jr. of Contemp. Res. in Multi. PEER-REVIEWED JOURNAL Volume 4 Issue 6 [NovDec] Year 2025 243 © 2025 Dr. Omkar Eswara Babu Danda, Dr. Jaheer Shaik, Dr. Rajeswari Putchala, Dr. Chandra Kiran Venkata Sai Pathur. This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International License (CC BY NC ND).https://creativecommons.org/licenses/by/4.0/ Research Article Comparative Evaluation of Postoperative Pain Following Unintentional Periapical Extrusion of Three Root Canal Sealers: A Prospective Clinical Study Dr. Omkar Eswara Babu Danda 1*, Dr. Jaheer Shaik 2, Dr. Rajeswari Putchala 3, Dr. Chandra Kiran Venkata Sai Pathur4 1 MDS, Senior Lecturer, Conservative Dentistry & Endodontics, Care Dental College, Guntur, Andhra Pradesh, India 2 Professor, Department of Conservative Dentistry and Endodontics, CARE Dental College, Andhra Pradesh, India 3 Senior Lecturer, St. Joseph's Dental College, Duggirala, NTR University of Health Sciences, Andhra Pradesh, India 4 MDS, Consultant Oral & Maxillofacial Surgeon, Department of Oral & Maxillofacial Surgery, Sibar Institute of Dental Sciences, Ongole, Prakasam, Andhra Pradesh, India Corresponding Author: *Dr. Omkar Eswara Babu Danda DOI: https://doi.org/10.5281/zenodo.17723094 Abstract Manuscript Information Background: Unintentional apical extrusion of root canal sealers is a common occurrence and may result in postoperative pain of varying intensity. Aim: To compare the intensity of postoperative pain following radiographically confirmed sealer extrusion using zinc oxide-eugenol (ZOE), AH Plus, and RoekoSeal sealers. Materials & Methods: Ninety single-rooted teeth with unintentional sealer extrusion visible on postoperative radiographs were prospectively included and divided into three groups (n=30 each) according to the sealer used: Group 1 – ZOE, Group 2 – AH Plus, Group 3 – RoekoSeal. Pain intensity was recorded using a 100-mm Visual Analogue Scale (VAS) at 0–6 h, 6–12 h, and 12–24 h postoperatively. Results: Mean VAS scores were highest in the ZOE group at all time intervals, followed by AH Plus and RoekoSeal. Statistically significant differences were observed between ZOE and the other two sealers at all time points (p < 0.05, Kruskal-Wallis test). Conclusion: Within the limitations of this prospective clinical study, RoekoSeal was associated with the least postoperative pain, while ZOE-based sealer caused the most intense discomfort when extruded periapically. ▪ ISSN No: 2583-7397 ▪ Received: 19-10-2025 ▪ Accepted: 22-11-2025 ▪ Published: 26-11-2025 ▪ IJCRM:4(6); 2025: 243-248 ▪ ©2025, All Rights Reserved ▪ Plagiarism Checked: Yes ▪ Peer Review Process: Yes How to Cite this Article Danda OEB, Shaik J, Putchala R, Pathur CKVS. Comparative Evaluation of Postoperative Pain Following Unintentional Periapical Extrusion of Three Root Canal Sealers: A Prospective Clinical Study. Int J Contemp Res Multidiscip. 2025;4(6):243-248. Access this Article Online www.multiarticlesjournal.com KEYWORDS: Postoperative pain, root canal sealer, overextrusion, zinc oxide eugenol, AH Plus, RoekoSeal, Visual Analogue Scale Int. Jr. of Contemp. Res. in Multi. PEER-REVIEWED JOURNAL Volume 4 Issue 6 [NovDec] Year 2025 244 © 2025 Dr. Omkar Eswara Babu Danda, Dr. Jaheer Shaik, Dr. Rajeswari Putchala, Dr. Chandra Kiran Venkata Sai Pathur. This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International License (CC BY NC ND).https://creativecommons.org/licenses/by/4.0/ 1. INTRODUCTION Endodontic therapy has undergone substantial development in the past few decades, yet post-operative pain remains one of the most frequent and undesirable consequences encountered after root canal treatment. The incidence of pain varies greatly in the literature, ranging from 3% to 58%, and has been linked to multiple biological, microbial, and procedural factors. Among these, irritation of periapical tissues due to unintentional extrusion of filling materials — particularly root canal sealers — plays a major role in provoking acute inflammatory responses. Root canal sealers are an integral component of the obturation system, intended to fill canal irregularities, promote adhesion between gutta-percha and dentinal walls, and create a threedimensional hermetic seal. However, these materials may inadvertently be forced beyond the apical constriction during obturation due to over-instrumentation, lack of apical stop, excessive lateral compaction pressure, or anatomical variations such as wide apical foramina. Once sealer extrusion occurs, the material directly contacts periapical connective tissues, periodontal ligament, and sometimes even bone, thereby stimulating an inflammatory cascade. The degree of tissue reaction varies significantly depending on the physicochemical properties of the sealer, including cytotoxicity, solubility, setting characteristics, thermal insult, and rate of degradation. Pro-inflammatory mediators and neuropeptides released in response to sealer toxicity contribute to symptomatic flare-ups, spontaneous pain, swelling, and delayed healing. Hence, the choice of sealer becomes a decisive clinical factor, especially in cases with wide apical foramina or compromised apical morphology. Zinc Oxide Eugenol (ZOE)–based sealers have been widely used for decades due to affordability and antimicrobial properties. However, the free eugenol released during setting is known to produce strong cytotoxic effects on periapical tissues and peripheral nerves, often aggravating pain after extrusion. Literature reports indicate that ZOE sealers not only elicit acute irritation but may also persist for extended durations due to slow degradation, resulting in sustained inflammatory reactions. AH Plus, an epoxy-resin-based sealer, represents a more contemporary material with excellent dimensional stability, adhesion, low solubility, and reduced cytotoxicity relative to ZOE. Despite these advantages, earlier investigations have documented that AH Plus may release unreacted amines and epoxy monomers during its initial setting period, which can irritate adjacent tissues; therefore, extrusion may still provoke moderate immediate post-operative pain. Roekoseal, a silicone-based sealer, is considered more biocompatible than both ZOE and epoxy-resin sealers. Its inert composition, low cytotoxicity, and minimal solubility enable favourable tissue tolerance. Extrusion of Roekoseal rarely elicits prolonged irritation, and its soft consistency allows physiological encapsulation rather than persistent inflammatory insult. For this reason, it has been recommended in cases requiring maximal biocompatibility. Despite multiple studies assessing the performance of different sealers, clinical literature comparing post-operative pain specifically due to accidental apical extrusion in vivo remains limited. Most previous research focuses on in vitro cytocompatibility, solubility, or sealing ability rather than patient-reported pain outcomes at specific post-treatment intervals. Because pain perception is subjective and strongly influenced by tissue response over time, it becomes essential to quantify pain at standardised time intervals using reliable assessment tools. The Visual Analogue Scale (VAS) is a widely accepted method for evaluating subjective pain intensity in endodontics. It provides a quantitative measure allowing comparison across studies and materials. Pain assessment during the first 24 hours post-treatment is critical because the acute inflammatory phase is most active during this period. A sealer that induces minimal pain during this early stage is likely to be advantageous for patient comfort, faster healing, and improved compliance. The present in-vivo investigation evaluates and compares the post-operative pain elicited by the unintentional extrusion of three commonly used root canal sealers — ZOE, AH Plus, and Roekoseal — by analysing VAS scores recorded at 0–6, 6–12, and 12–24 hours after obturation. By correlating pain patterns with the biological properties of the sealers, this study attempts to provide clinically relevant evidence that can guide appropriate material selection, particularly in cases where apical extrusion risk is high. Given the current clinical emphasis on minimally invasive and biologically conservative endodontics, identifying a sealer that elicits minimal inflammatory response upon extrusion is of paramount importance. The findings of this study address a major gap in the literature by presenting evidence-based insight on acute pain associated with three widely used sealers under real clinical conditions. This prospective clinical study was therefore designed to compare postoperative pain intensity within the first 24 hours following unintentional extrusion of three commonly used root canal sealers with distinct chemical compositions. 2. MATERIALS AND METHODS Study design: Prospective consecutive-patient cohort study Sample: Ninety single-rooted teeth requiring root canal treatment in patients aged 18–55 years were included consecutively. Only teeth exhibiting definite radiographic evidence of sealer extrusion beyond the apical foramen in postoperative periapical radiographs were finally enrolled. Int. Jr. of Contemp. Res. in Multi. PEER-REVIEWED JOURNAL Volume 4 Issue 6 [NovDec] Year 2025 245 © 2025 Dr. Omkar Eswara Babu Danda, Dr. Jaheer Shaik, Dr. Rajeswari Putchala, Dr. Chandra Kiran Venkata Sai Pathur. This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International License (CC BY NC ND).https://creativecommons.org/licenses/by/4.0/ Figure 1: Periapical radiographs showing unintentional extrusion of root canal sealers beyond the root apex. Allocation: All teeth were cleaned using a rubber cup and pumice prophylaxis. Standard protocol for administration of local anaesthesia was followed (2% lignocaine with adrenaline 1:80,000), followed by rubber dam isolation. Access preparation was done, and working length was established using both the radiographic method and an apex locator. Biomechanical preparation was completed using the step-back technique with standard irrigation protocols. Obturation was performed using the cold lateral condensation technique with non-standardised gutta-percha cones. The teeth were obturated using one of three sealers: • Group I — Zinc Oxide Eugenol (ZOE) • Group II — AH Plus • Group III — Roekoseal Clinical procedure: Standard nonsurgical root canal treatment was performed under a rubber dam by two experienced operators using step-back preparation and cold lateral condensation obturation. Pain assessment: Patients marked their pain intensity on a 100mm VAS at 0–6 h, 6–12 h, and 12–24 h postoperatively. Patients were not informed about the sealer type. Statistical analysis: Data were analysed using the KruskalWallis test followed by Dunn’s post-hoc test. Significance level was set at p < 0.05. Figure 2: The three endodontic sealers used in the present study: (a) Zinc Oxide Eugenol (ZOE), (b) AH Plus, and (c) Roekoseal. Int. Jr. of Contemp. Res. in Multi. PEER-REVIEWED JOURNAL Volume 4 Issue 6 [NovDec] Year 2025 246 © 2025 Dr. Omkar Eswara Babu Danda, Dr. Jaheer Shaik, Dr. Rajeswari Putchala, Dr. Chandra Kiran Venkata Sai Pathur. This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International License (CC BY NC ND).https://creativecommons.org/licenses/by/4.0/ The access cavities were restored with glass ionomer cement, and postoperative periapical radiographs were obtained. Pain intensity was assessed using the Visual Analogue Scale (VAS) score at 0–6 hours, 6–12 hours, and 12–24 hours after obturation. Pain was categorised as: • None (0–4 mm) • Mild (5–44 mm) • Moderate (45–74 mm) • Severe (75–100 mm) 3. RESULTS Mean and Standard Deviation of Visual Analogue Scale Scores Using ANOVA. Group / Time interval 0–6 hours (Mean ± SD) 6–12 hours (Mean ± SD) 12–24 hours (Mean ± SD) Zinc Oxide Eugenol (n = 30) 37.13 ± 34.06 46.34 ± 27.56 12.48 ± 18.32 AH Plus (n = 30) 18.23 ± 24.74 38.68 ± 28.44 6.58 ± 4.76 Roekoseal (n = 30) 10.32 ± 14.42 28.32 ± 16.48 3.24 ± 2.22 Intergroup Comparison Using Kruskal–Wallis Test Time interval A vs. B A vs. C B vs. C 0–6 hours 0.038 0.661 0.018 6–12 hours 0.000 0.524 0.05 12–24 hours 0.015 0.559 0.041 Level of significance: p < 0.05 4. DISCUSSION Post-operative pain following root canal treatment remains a clinically relevant problem, despite several improvements in materials and instrumentation. The current study investigated the extent of pain associated with the unintentional extrusion of three endodontic sealers — Zinc Oxide Eugenol (ZOE), AH Plus, and Roekoseal — at three postoperative intervals using the Visual Analogue Scale (VAS). A consistent trend emerged, wherein ZOE produced the highest pain intensity, followed by AH Plus and then Roekoseal across all observation periods. Understanding the biological and chemical behaviour of these sealers offers insight into the observed outcomes. The immediate post-operative pain (0–6 hours) was significantly higher in the ZOE group compared with AH Plus and Roekoseal. This can be attributed to the irritant effect of eugenol, which is known to trigger acute inflammatory responses in periapical tissues. Eugenol diffuses rapidly across periapical vasculature and may stimulate nociceptors directly, leading to spontaneous pain and exaggerated sensitivity. The substantial mean VAS score of 37.13 ± 34.06 for ZOE reflects the inflammatory potential of this sealer during its initial setting. In contrast, Roekoseal’s softer composition and inert biointeraction likely contributed to its considerably lower mean pain score of 10.32 ± 14.42, reinforcing the notion that the biological compatibility of materials influences clinical symptoms. In the 6–12-hour interval, the ZOE group showed not only persistence but intensification of pain (mean = 46.34 ± 27.56). This sustained pain pattern corresponds with the slow setting time of ZOE, during which free eugenol remains unbound and chemically active. The cytotoxic effects of ZOE have been extensively documented, including damage to fibroblasts, macrophages, and osteoblasts. The pain score decreased in the AH Plus group compared with ZOE supports prior work indicating that resin-based sealers, although mildly cytotoxic at early stages due to epoxy-amine release, gradually stabilise as polymerisation progresses. Interestingly, Roekoseal again demonstrated the lowest pain intensity in this interval, suggesting minimal inflammatory potential. The final pain assessment interval (12–24 hours) showed a significant reduction in pain across all groups, consistent with the natural decline of acute inflammatory mediators. However, ZOE continued to elicit substantially higher pain than the other two sealers, with a mean score of 12.48 ± 18.32. The presence of eugenol or persistent necrotic pathology near tissues may prolong sensitisation of periapical nerve fibres. AH Plus showed markedly reduced pain (mean = 6.58 ± 4.76), coinciding with near-completion of polymerisation and stabilisation of resin components. Roekoseal demonstrated the least pain during this period as well (mean = 3.24 ± 2.22), indicating that silicone-based sealers may remain passive even after initial extrusion. The results align with biological expectations based on known material chemistry. ZOE sealers, while antibacterial, possess significant cytotoxicity during and shortly after setting. Epoxy resin–based sealers have lower cytotoxicity but still release irritants during polymerisation. Roekoseal’s silicone matrix confers excellent biocompatibility, with minimal cellular damage or inflammatory response reported in earlier literature. The findings are also supported by previous clinical and histological studies. Scolozzi et al. reported that extrusion of ZOE-based sealers could induce severe postoperative pain requiring surgical intervention in rare cases, a finding that matches the exaggerated early pain noted in the present study. Govind Shashirekha et al. demonstrated higher pain levels associated with AH Plus compared with ZOE during the initial 12 hours; however, their study did not include Roekoseal and suggested that AH Plus irritation subsides rapidly due to polymerisation. The present findings extend that knowledge by providing a three-way comparison and showing that both ZOE and AH Plus produce higher early pain than Roekoseal. Clinical interpretation of these results suggests that the biological tolerance of periapical tissues depends strongly on the chemical nature of the extruded sealer. When sealer extrusion is anticipated — such as in teeth with open or widened foramina, resorption, or immature root morphology — a more biocompatible sealer may be preferable. Conversely, in cases where extrusion risk is minimal, sealer biocompatibility may not critically influence postoperative outcomes. Another relevant point is the time-bound evolution of pain. In all groups, pain significantly decreased after 12 hours. This supports the understanding that post-operative discomfort is Int. Jr. of Contemp. Res. in Multi. PEER-REVIEWED JOURNAL Volume 4 Issue 6 [NovDec] Year 2025 247 © 2025 Dr. Omkar Eswara Babu Danda, Dr. Jaheer Shaik, Dr. Rajeswari Putchala, Dr. Chandra Kiran Venkata Sai Pathur. This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International License (CC BY NC ND).https://creativecommons.org/licenses/by/4.0/ directly linked to the acute phase of inflammation and resolves spontaneously unless active infection persists. No cases in the present study reported prolonged unresolved pain, suggesting that although the degree of pain differs based on material, natural recovery occurs across sealers within the first day. This study has several strengths: • It assesses pain as a primary clinical outcome rather than a secondary observation. • Pain was measured using a standardised VAS scale. • The group sizes were equal and balanced. • Real-world clinical cases were included rather than simulated models. However, some limitations must be considered. Pain is inherently subjective and influenced by factors such as individual pain threshold, anxiety, systemic health, and operator variability. Although standard protocols were followed, obturation pressure may vary between practitioners. Follow-up was limited to 24 hours and did not evaluate delayed pain or long-term tissue healing. Future studies may consider long-term CBCT evaluation to correlate radiographic healing patterns with extrusion type. Additionally, the comparative role of sealer volume extruded — not only extrusion presence — may offer further insight into pain stimulus thresholds. 5. CONCLUSION Within the limitations of this in vivo investigation, it can be concluded that postoperative pain following root canal treatment is significantly influenced by the type of extruded endodontic sealer. All three tested sealers demonstrated a gradual reduction in pain over 24 hours; however, the degree of pain intensity varied distinctly among groups. Zinc Oxide Eugenol consistently produced the highest Visual Analogue Scale (VAS) scores at all postoperative intervals, indicating a stronger inflammatory response when displaced into periapical tissues. AH Plus produced comparatively lower pain scores than ZOE, although its initial postoperative discomfort remained clinically relevant, possibly due to the release of unreacted resin components during polymerisation. Roekoseal exhibited the lowest postoperative pain at every recorded interval, indicating superior tissue tolerance and biocompatibility when unintentionally extruded. The clinical implication of these findings is that the biological interaction of sealing materials becomes particularly critical in clinical scenarios where extrusion risk is high, such as widened apical foramina, apical resorption, or over-prepared canals. Although careful obturation technique remains the most important means of avoiding sealer extrusion, material selection can serve as an additional protective factor in minimising patient discomfort during the acute healing phase. Further longterm clinical trials incorporating radiographic healing and histopathologic evaluation may provide a deeper understanding of the sequelae of sealer extrusion. Overall, this study reinforces that postoperative pain is not only a procedural outcome but also a biomaterial-dependent phenomenon, and clinicians should remain aware of how different sealers may influence patient comfort during the early postoperative period. FUNDING: No Funding CONFLICT OF INTEREST: The Author declares no conflict Limitations 1. Lack of randomisation and blinding of operators and patients due to distinctly different handling characteristics of the sealers. 2. Quantitative assessment of extruded sealer volume was not performed because of the inherent limitations of twodimensional radiographs. 3. Relatively short observation period of 24 hours. 4. Influence of individual pain threshold and possible use of rescue analgesics (although patients were instructed to record pain before taking any medication). These limitations should be addressed in future randomised controlled trials with three-dimensional imaging and longer follow-up. REFERENCES 1. Dalopoulou A, et al. Extrusion of root canal sealer in periapical tissues – Report of two cases with different treatment management and literature review. Baulk J Dent Med. 2017;21:12-18. 2. Govind Shashirekha, et al. Assessment of pain and dissolution of apically extruded sealers and their effect on the periradicular tissues. J Conserv Dent. 2018;21:546-50. 3. Gençoğlu N, et al. A new silicon-based root canal sealer (Roekoseal Automix). J Oral Rehabil. 2003;30:753-757. 4. Cintra LTA, et al. Evaluation of inflammatory response to different sealers in rat subcutaneous tissue. J Endod. 2017;43:1679-84. 5. Siqueira JF Jr, Rocas IN. Clinical implications and microbiology of postoperative pain following endodontic treatment. Clin Oral Investig. 2008;12:21-29. 6. Donnermeyer D, et al. Physicochemical and biological properties of epoxy resin-based sealers: A systematic review. Materials (Basel). 2021;14:1-16. 7. Cohen S, Hargreaves KM. Pathways of the Pulp – Chapter on postoperative pain and inflammatory mediators. St. Louis: Mosby Elsevier. 2016. p. 569-590. Int. Jr. of Contemp. Res. in Multi. PEER-REVIEWED JOURNAL Volume 4 Issue 6 [NovDec] Year 2025 248 © 2025 Dr. Omkar Eswara Babu Danda, Dr. Jaheer Shaik, Dr. Rajeswari Putchala, Dr. Chandra Kiran Venkata Sai Pathur. This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International License (CC BY NC ND).https://creativecommons.org/licenses/by/4.0/ 8. de Deus G, et al. Cytotoxicity of root canal sealers depends on the setting reaction and exposure time. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007;104:e138-42. 9. Khetarpal A, Chaudhary S, et al. Comparative evaluation of postoperative pain after obturation using AH Plus, Sealapex and Roekoseal. Indian J Dent Res. 2019;30:256-61. 10. Balto K, et al. Tissue response to apical extrusion of endodontic sealers: An in-vivo histological study. Int Endod J. 2012;45:1015-23. Creative Commons (CC) License This article is an open-access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY 4.0) license. This license permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. About the Corresponding author Dr. Omkar Eswara Babu Danda, MDS, is a Senior Lecturer in the Department of Conservative Dentistry and Endodontics at Care Dental College, Guntur, Andhra Pradesh. His academic and clinical interests include root canal materials, endodontic pain management, and minimally invasive dentistry. He actively contributes to research and dental education.