Evaluation of the efficacy of calcium silicate vs. glass ionomer cement indirect pulp capping and restoration assessment criteria: a randomised controlled clinical trial—2-year results.

Objectives: Assess calcium silicate cement (Biodentine™) vs. glass ionomer cement (Fuji IX™, control) as indirect pulp capping (IPC) materials in patients with reversible pulpitis after a 2-year follow-up. Evaluate the integrity of the overlying resin composite restorations using modified USPHS criteria and FDI criteria. Investigate the sensitivity of the modified USPHS criteria compared to the FDI criteria in the assessment of the restorations.Materials and methods: Seventy-two restorations (36 Biodentine™, 36 Fuji IX™) were placed randomly in 53 patients. Periapical radiographs were taken at pre-treatment (T0), 12-month (T12), and 24-month (T24) review. Restorations were assessed using the modified USPHS and FDI criteria at T12 and T24.Results: At 24 months, 15 teeth had failed to maintain vitality (6 Biodentine™, 9 Fuji IX™). Clinical success rate of IPC for both materials was 72% and is related to the intensity of reversible pulpitis symptoms. No difference was found between T12 and T24 in the periapical (PA) radiographs and in the integrity of the resin composite restorations overlying Biodentine™ compared to Fuji IX™. There was no difference in the efficacy of the USPHS criteria compared to the FDI criteria in the assessment of the resin composite restorations.Conclusions: Biodentine™ and Fuji IX™ were clinically effective when used as IPC materials in teeth with reversible pulpitis at T24. Resin composite restorations overlying both materials performed well at T24. Using the USPHS or FDI criteria is equally efficient at T24; however, longer term follow-up is needed to establish whether there are sensitivity differences between these assessment criteria.Clinical significance: Teeth with deep carious lesions approaching the pulp and with signs of reversible pulpitis can be treated successfully by indirect pulp capping using either Biodentine™ or Fuji IX™. Using the USPHS or FDI criteria to assess restorations is equally effective at 2 years.Trial registration: NCT02201641 [ABSTRACT FROM AUTHOR]