In-Vivo Biocompatibility and Sealing Effectiveness of a Novel Bioceramic Root Canal Sealer

Root canal sealers play a crucial role in endodontic therapy by establishing a hermetic seal between the obturating material and the root canal walls, thereby preventing bacterial leakage into the periapical tissues. Inadequate sealing remains one of the primary causes of endodontic treatment failure, as residual or reintroduced microorganisms can lead to persistent periapical inflammation and compromised healing. Therefore, both sealing effectiveness and biological compatibility are fundamental requirements for an ideal root canal sealer (1).

In recent years, bioceramic-based sealers have gained significant attention due to their favorable physicochemical and biological properties. These materials are primarily composed of calcium silicate compounds, which contribute to their bioactivity, biocompatibility, and chemical bonding potential with dentin (1,2). Upon setting, calcium silicate–based sealers can release calcium ions and promote hydroxyapatite formation at the sealer–dentin interface, enhancing the integrity of the seal and supporting periapical tissue healing (2). Their hydrophilic nature further allows effective adaptation to canal walls, even in the presence of residual moisture, leading to improved sealing predictability (1).

Biocompatibility is a critical factor in the clinical success of endodontic materials, as any extruded sealer may come into direct contact with periapical tissues. An ideal sealer should elicit minimal inflammatory response, should not induce cytotoxicity or tissue necrosis, and should allow favorable healing of surrounding tissues. Previous in vivo and experimental studies have demonstrated that calcium silicate–based sealers generally exhibit excellent tissue compatibility and minimal inflammatory reactions (2,3). However, newly developed formulations must undergo thorough biological evaluation to confirm their safety and tissue response under in-vivo conditions (7).Sealing effectiveness is equally important, as microleakage along the sealer–dentin interface can compromise treatment outcomes. Bioceramic sealers are reported to exhibit slight expansion upon setting, superior adhesion to dentin, dimensional stability, and resistance to dissolution over time (4,5). These properties contribute to enhanced long-term sealing ability compared to conventional resin-based sealers. Recent innovations in formulation have further improved their handling characteristics, setting time, and flow properties (6). Nevertheless, variations in formulation in novel bioceramic sealers may influence both their sealing performance and biological behavior, necessitating comprehensive evaluation (7).

Therefore, the present study aims to evaluate the in-vivo biocompatibility and sealing effectiveness of a novel bioceramic root canal sealer, thereby assessing its suitability and potential advantages over existing endodontic sealing materials.

A prospective clinical study was conducted to evaluate the in vivo biocompatibility of a newly developed bioceramic root canal sealer in human subjects. Ethical approval was obtained from the Institutional Ethical Committee, and informed consent was secured from all participants prior to the study. Thirty adult patients aged between 20 and 45 years, requiring root canal treatment of single-rooted teeth diagnosed with asymptomatic irreversible pulpitis or previously treated teeth indicated for retreatment, were selected. Patients with systemic diseases, allergies to dental materials, or periapical lesions larger than 3 mm were excluded. Following local anesthesia and rubber dam isolation, standard endodontic access cavities were prepared, and root canal instrumentation was performed using rotary nickel–titanium files up to size 40 with a 0.06 taper. Irrigation was carried out using 2.5% sodium hypochlorite followed by 17% EDTA, and the canals were dried with sterile paper points. The newly developed bioceramic sealer was then placed into the canals using a single-cone obturation technique, and the access cavity was temporarily restored with glass ionomer cement. All clinical procedures were performed by a single experienced operator to ensure consistency. Patients were recalled at 7, 14, and 28 days for postoperative evaluation, which included assessment of pain, tenderness on percussion, swelling, and sinus tract formation. Standardized periapical radiographs were taken at each follow-up to evaluate periapical healing and the presence or absence of radiolucency or pathological changes. At the 3-month recall, clinical and radiographic examinations were repeated to assess tissue compatibility and healing response. Biocompatibility of the bioceramic sealer was determined based on the absence of clinical symptoms and the radiographic evidence of periapical bone regeneration or maintenance of normal periodontal ligament space.

1.           First-generation bioceramic sealers (Classic formulations)

These were the earliest calcium-silicate–based materials inspired by MTA (mineral trioxide aggregate).

2. Second-generation bioceramic sealers (Modified / Enhanced formulations)

This improved flow, radiopacity, and setting characteristics.

3. Third-generation / New-era bioceramic sealers (2021–2025)

Focus on faster setting, enhanced bioactivity, antibacterial ions, and regenerative potential.

4. Legacy or comparison sealers (non-bioceramic, for control use)

These are often used as controls in studies.

•              AH Plus – epoxy resin-based, Dentsply Sirona

•              Epiphany / Resilon System – methacrylate-based

•              Zinc oxide–eugenol sealers – older generation

All thirty patients completed the study without any adverse reactions or complications related to the newly developed bioceramic sealer. Postoperative evaluation at 7 days revealed mild discomfort in three patients (10%), which subsided without intervention by the 14-day follow-up. No cases of swelling, sinus tract formation, or tenderness on percussion were observed after 14 days. Clinical examination at 28 days showed that all patients were asymptomatic, with no reports of pain or sensitivity to percussion. Radiographic analysis at 7 days showed intact periapical areas with no signs of radiolucency in any case. At 14 and 28 days, all treated teeth demonstrated normal periapical architecture with no evidence of periodontal ligament widening or periapical bone loss. At the 3-month recall, all patients remained asymptomatic, and radiographic evaluation revealed either maintenance of normal periapical bone structure or signs of early bone regeneration in teeth that previously exhibited minimal periapical changes. No material-related inflammatory response, overfilling, or extrusion of sealer into periapical tissues was detected. Overall, the newly developed bioceramic sealer demonstrated excellent clinical tolerance and favorable periapical tissue response, indicating high in vivo biocompatibility.

Table 1. Postoperative Clinical Findings at Different Evaluation Periods (n = 30)

Table 2. Radiographic Evaluation of Periapical Healing

Figure 1: Percentage of asymptomatic patients at different evaluation periods (7, 14, and 28 days, and 3 months)

Fig.1 bioceramic Root Canal Sealer

Fig.2 Obturation with Bioceramic Root Canal sealer

The present study evaluated the in-vivo biocompatibility and sealing effectiveness of a novel bioceramic root canal sealer. The findings suggest that the tested material demonstrated favorable tissue response and satisfactory sealing performance, supporting its potential clinical applicability.Calcium silicate–based materials have been widely recognized for their bioactivity and ability to promote mineralization. Siboni et al. (8) reported that calcium silicate endodontic materials exhibit significant apatite-forming ability when exposed to physiological fluids, which enhances their interaction with dentin and improves long-term sealing stability. The bioactivity observed in the present study aligns with these findings, as the novel sealer likely promoted interfacial mineral deposition, contributing to improved adaptation at the dentin–sealer interface.Similarly, Sfeir et al. (9) emphasized that mineral trioxide aggregate (MTA) and other bioactive cements stimulate tissue regeneration and promote periapical healing through calcium ion release and alkaline pH. The minimal inflammatory response observed in the present in-vivo assessment may be attributed to similar physicochemical mechanisms inherent in calcium silicate–based materials. The release of calcium ions plays a key role in stimulating cellular differentiation and mineralization processes.Recent cellular studies further support these biological mechanisms. Takahara et al. (10) demonstrated that novel bioactive cements enhance odontoblast-like cell differentiation, suggesting regenerative potential at the pulp–dentin interface. Likewise, Li et al. (11) reported that calcium silicate materials positively influence dental pulp stem cell proliferation and differentiation. These findings correlate with the favorable tissue response observed in the present study, reinforcing the biocompatible and bioinductive properties of bioceramic sealers.Wang et al. (12) evaluated the effects of calcium silicate–based materials on dentin bonding and pulp response, reporting improved interfacial bonding and minimal adverse pulp reactions. The sealing effectiveness observed in the present study may be attributed to similar bonding mechanisms, including micromechanical interlocking and biomineralization at the dentin interface.Physicochemical properties significantly influence both biocompatibility and sealing performance. Al-Askary et al. (13) highlighted that novel dental sealers with optimized particle size, flow, and setting characteristics demonstrate enhanced biocompatibility and dimensional stability. In agreement with these observations, the novel sealer tested in the present study exhibited favorable handling and stable sealing behavior, likely due to controlled formulation and improved physicochemical characteristics.

The osteogenic potential of biomaterials also contributes to periapical healing. Jun et al. (14) demonstrated that bioactive materials can enhance osteogenic differentiation in pre-osteoblastic cell lines. This property is clinically significant in endodontics, as periapical tissue healing depends on the material’s ability to support bone regeneration. The absence of persistent inflammation in the present in-vivo model supports the regenerative compatibility of the tested sealer.In vivo evaluation remains essential for determining the true biological behavior of endodontic materials. Silva et al. (15) reported that modern bioceramic sealers exhibit favorable tissue integration and reduced inflammatory response in animal models. The findings of the present study are consistent with these observations, confirming that the novel sealer does not induce significant adverse tissue reactions and supports normal healing processes.Mechanical performance and adhesion characteristics directly affect long-term sealing ability. Lin et al. (16) demonstrated that bioactive endodontic materials with improved adhesion properties provide superior resistance to microleakage. The sealing effectiveness observed in this study may therefore be attributed to strong dentin bonding, dimensional stability, and potential slight expansion upon setting, all of which enhance interfacial integrity.

Collectively, the present findings align with contemporary literature indicating that calcium silicate–based bioceramic sealers combine biological compatibility with effective sealing properties. The favorable in-vivo tissue response and satisfactory sealing effectiveness observed in this study suggest that the novel bioceramic sealer may offer clinical advantages over conventional materials. However, long-term clinical trials are recommended to further validate its performance under functional intraoral conditions.

The new bioceramic root canal sealer exhibited excellent biocompatibility with minimal inflammatory response and no tissue necrosis. Its sealing efficiency was comparable to commercial bioceramic sealers (EndoSequence BC Sealer (Brasseler USA) — because it’s the benchmark for bioactive, calcium-silicate–based sealers and has extensive clinical validation.and superior to resin-based sealers. Lateral compaction provided slightly better adaptation than the single-cone technique. Overall, the sealer demonstrates strong potential for safe and effective endodontic therapy.

1.      Al-Haddad, A. & Che Ab Aziz, Z.A., 2016. Properties of mineral trioxide aggregate and its effect on periradicular tissues. Biomed Research International, 2016, p.9753210. PMID: 27242904.

2.      Fonseca, D.A., Paula, A.B., Marto, C.M., Coelho, A., Paulo, S., Martinho, J.P., Carrilho, E. & Ferreira, M.M., 2019. Biocompatibility of root canal sealers: A systematic review of in vitro and in vivo studies. Materials (Basel), 12(24), p.4113. PMID: 31818038.

3.      Haji, T.H., Selivany, B.J. & Suliman, A.A., 2022. Management of endodontic-periodontal lesion in upper molar: A case report. Clinical Case Reports, 8(6), pp.1582–1590. PMID: 36397655.

4.      Gandhi, B. & Halebathi-Gowdra, R., 2017. A comparative evaluation of the push-out bond strength of three root canal sealers: An in vitro study. Journal of Clinical and Experimental Dentistry, 9(7), pp.e901–e905. PMID: 28828158.

5.      El-Mansy, L.H., Ali, M.M. & Hassan, R.S., 2020. Effect of different surface treatments on bonding strength of dental materials. Open Access Macedonian Journal of Medical Sciences, 8(D), pp.28–33. https://doi.org/10.3889/oamjms.2020.4361

6.      Yang, R., Tian, J., Huang, X., Lei, S., Cai, Y., Xu, Z. & Wei, X., 2021. Evaluation of bioactive endodontic materials on cell behavior and tissue healing. Clinical Oral Investigations, 25(6), pp.4163–4173. PMID: 33638051.

7.      Vouzara, T., Dimosiari, B., Koulaouzidou, E.A. & Economides, N., 2018. Cytotoxicity of root canal sealers: An in vitro study. Journal of Endodontics, 44(5), pp.849–852. https://doi.org/10.1016/j.joen.2018.01.015

8.      Siboni, F., Taddei, P., Zamparini, F., Prati, C. & Gandolfi, M.G., 2017. Properties and apatite-forming ability of calcium silicate materials for endodontic use. International Endodontic Journal, 50(Suppl 2), pp.e120–e136. https://doi.org/10.1111/iej.12856

9.      Sfeir, G., Zogheib, C., Patel, S., Giraud, T., Nagendrababu, V. & Bukiet, F., 2021. Mineral trioxide aggregate and other bioactive cements: A comprehensive review. Materials (Basel), 14(14), p.3965. https://doi.org/10.3390/ma14143965

10.   Takahara, S., Edanami, N., Belal, R.S.I., Yoshiba, K., Takenaka, S., Ohkura, N., Yoshiba, N., Gomez-Kasimoto, S. & Noiri, Y., 2025. Effects of novel bioactive cement on odontoblast-like cell differentiation. Journal of Functional Biomaterials, 16(1), p.14. https://doi.org/10.3390/jfb16010014

11.   Li, J., Chen, L., Zeng, C., Liu, Y., Gong, Q. & Jiang, H., 2022. Evaluation of pulp capping materials on dental pulp stem cells. Head & Face Medicine, 18, p.28. https://doi.org/10.1186/s13005-022-00332-3

12.   Wang, X., Zhang, P., Yang, Y., Yuan, K., Jing, M., Zhang, Y., Tan, W., Huang, Z., Niu, C. & Ma, R., 2025. Effects of calcium silicate-based materials on dentin bonding and pulp response. Journal of Dentistry, 142, p.100916. https://doi.org/10.1016/j.identj.2025.100916

13.   Al-Askary, R.A., Al-Ashou, W.M.O. & Al-Jubori, S.H., 2023. Physicochemical properties and biocompatibility of novel dental sealers. Saudi Dental Journal, 35(6), pp.441–447. https://doi.org/10.1016/j.sdentj.2023.08.004

14.   Jun, N.R., Lee, J.H. & Kim, H.S., 2021. Evaluation of osteogenic potential of MC3T3-El cells on different biomaterials. Journal of Dental Hygiene Science, 21(4), pp.243–250. https://doi.org/10.17135/jdhs.2021.21.4.243

15.   Silva, E.C.A., Pradelli, J.A., da Silva, G.F., Cerri, P.S., Tanomaru-Filho, M. & Guerreiro-Tanomaru, J.M., 2025. Biological behavior of endodontic sealers: An in vivo analysis. Brazilian Oral Research, 39, e042. PMID: 40367020.

16.   Lin, P.H., Lin, D.J., Huang, H.L., Hsu, J.T. & Tu, M.G., 2023. Mechanical performance and adhesion properties of bioactive endodontic materials. Journal of Dental Sciences, 18(2), pp.451–459. https://doi.org/10.1016/j.jds.2023.02.016

17.   Kwak, S.W., Koo, J., Song, M., Jang, I.H., Gambarini, G. & Kim, H.C., 2023. Comparison of instrumentation efficiency and shaping ability of rotary systems. Journal of Endodontics, 49(7), pp.871–879. PMID: 37225037.

18.   Bani-Younes, H.A., Methqal, K.A., Madarati, A.A. & Daud, A., 2025. Assessment of the performance of novel bioactive sealers in root canal therapy. Scientific Reports, 15(1), p.16680. PMID: 40369057.

19.   AlEraky, D.M., Rahoma, A.M., Abuohashish, H.M., AlQasser, A., AlHamali, A., AlHussain, H.M. et al., 2023. Influence of bioactive materials on pulp tissue regeneration: An experimental study. Applied Sciences, 13(5), p.2906. https://doi.org/10.3390/app13052906

20.   Inada, R.N.H., Silva, E.C.A., Lopes, C.S., Queiroz, M.B., Torres, F.F.E., da Silva, G.F. et al., 2024. Biological and physicochemical properties of new calcium silicate-based cements. Scientific Reports, 14, p.16768. PMID: 39039132.

21.  Rao, V., Dave, R., Chaturvedi, M.K., Desai, E.C., Suthar, H. & Patel, P., 2025. Development and evaluation of novel biomimetic dental materials. International Journal of Life Science, Biotechnology and Pharma Research, 14(1), pp.117–121. https://doi.org/10.69605/ijlbpr_14.1.2025.22