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

Clin Oral Investig. 2021 Jun;25(6):3775-3787. doi: 10.1007/s00784-020-03707-5. Epub 2021 Jan 6.

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.

Keywords: Bioactive glass; Biodentine; Cytokines; ELISA; Primary teeth; Regenerative endodontics.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Aluminum Compounds*
  • Calcium Compounds
  • Child
  • Child, Preschool
  • Drug Combinations
  • Glass
  • Humans
  • Inflammation
  • Oxides
  • Pulpotomy*
  • Silicates
  • Tooth, Deciduous

Substances

  • Aluminum Compounds
  • Calcium Compounds
  • Drug Combinations
  • Oxides
  • SiO2-CaO glass
  • Silicates

Associated data

  • ClinicalTrials.gov/NCT03786302