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Tailored 70S30C Bioactive glass induces severe inflammation as pulpotomy agent in primary teeth: an interim analysis of a randomised controlled trial

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Abstract

Objectives

This study compared clinical, histologic, and inflammatory outcomes of Biodentine and Bioactive glass (70S30C-BAG) as pulpotomy agents in primary teeth.

Methods

A randomised, clinical trial was performed recruiting 70 children, 5–9 years old, having ≥ 1 tooth indicated for vital pulpotomy. Participants were randomised to Biodentine or 70S30C-BAG groups. Clinical evaluation was scheduled at 1, 3, 6, 9, and 12 months. Additional 16 teeth were extracted after 6 weeks to assess histologic and inflammatory response (IL-8/IL-10 ratio) using ELISA. Fisher exact, Mann Whitney U test, and t test were used to compare clinical, histologic outcomes and IL-8/IL-10 ratio.

Results

After 3 months, 10 teeth treated with Biodentine were clinically successful, while 9 teeth treated with 70S30C-BAG failed (P < 0.001) necessitating trial termination. Causes of failure were analysed by assessing the pH and ionic release of 70S30C-BAG. Biodentine-treated teeth showed minor inflammation, normal pulp, and hard tissue formation.70S30C-BAG-treated teeth showed severe inflammation, abscesses, root resorption without hard tissue formation. There was a significantly greater percent reduction of IL-8/IL-10 ratio in Biodentine than 70S30C-BAG (mean ± SD = 66.39 ± 18.56 and 40.66 ± 0.86, P = 0.02).

Conclusions

Biodentine showed favourable clinical, histologic, and anti-inflammatory outcomes, promoting pulp healing and regeneration. 70S30C-BAG resulted in pulp necrosis—through persistent inflammation—causing clinical failure.

Clinical relevance

Biodentine is a promising pulpotomy agent in primary teeth; it promoted healing and regeneration of the dentine-pulp complex. In its current form, 70S30C-BAG is not a suitable pulpotomy agent; it induced persistent inflammation, negating the pulp ability to heal and regenerate. TRN: NCT03786302, 12/19/2018.

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Acknowledgments

The authors are indebted to Dr. Noha ElShazly, Tissue Engineering Laboratory, Faculty of Dentistry, Alexandria University, Alexandria, Egypt for preparing the material used in this study, Dr. Nevien Mahmoud, Assistant Professor of Biochemistry, Pharos University in Alexandria, Egypt for performing the ELISA analysis, and Dr. Osama Abd Ellatif, Associate Professor of Physical Chemistry, Pharos University in Alexandria, Egypt for his guidance through the laboratory part of the study.

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  1. Yasmine Elhamouly

    Present address: Pediatric and Community Dentistry Department, Faculty of Dentistry, Pharos University in Alexandria, Alexandria, Egypt

Authors and Affiliations

  1. Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, Alexandria, Egypt

    Yasmine Elhamouly, Dalia M. Talaat, Maha El Tantawi & Karin M. L. Dowidar

  2. Conservative Dentistry Department, Faculty of Dentistry, Alexandria University, Alexandria, Egypt

    Rania M. El Backly

  3. Oral Biology Department, Faculty of Dentistry, Alexandria University, Alexandria, Egypt

    Samia S. Omar

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Contributions

Conceptualisation and study design: (Yasmine Elhamouly, Rania M El Backly, Maha El Tantawi, and Karin ML Dowidar); Performance of clinical and laboratory procedures, follow-up, data collection, writing, original draft preparation, editing: (Yasmine Elhamouly); Supervision of the clinical procedures: (Rania M El Backly, Dalia M Talaat, and Karin ML Dowidar); Randomisation and concealment: (Dalia M Talaat and Karin ML Dowidar); Follow-up, data analysis and interpretation: (Yasmine Elhamouly, Rania M El Backly, Dalia M Talaat, and Karin ML Dowidar); Supervising acquisition and retrieval of ELISA samples, analysis and interpretation of the laboratory data: (Rania M El Backly); Supervising processing of histological samples, analysis, interpretation, and acquisition of histological data: (Samia S Omar); Performing the statistical analysis, interim analysis, termination procedures and supervised registration of the clinical trial: (Maha El Tantawi); Reviewing: (Rania M El Backly, Samia S Omar, Dalia M Talaat, Maha El Tantawi and Karin ML Dowidar). All authors contributed to drafting of the manuscript, critical revision, and approval of the final manuscript.

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Correspondence to Yasmine Elhamouly.

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All procedures performed in the study involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. The study was approved by the Research Ethics Committee, Faculty of Dentistry, Alexandria University, Egypt, (IRB 00010556)-(IORG 0008839).

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Elhamouly, Y., El Backly, R.M., Talaat, D.M. et al. Tailored 70S30C Bioactive glass induces severe inflammation as pulpotomy agent in primary teeth: an interim analysis of a randomised controlled trial. Clin Oral Invest 25, 3775–3787 (2021). https://doi.org/10.1007/s00784-020-03707-5

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