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

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.