Objectives: This randomized, controlled, pilot study assessed the outcome of non-surgical primary/secondary root canal treatments either with a novel bioactive sealer and the single-cone technique or with gutta-percha, zinc oxide-eugenol sealer (ZOE), and warm vertical compaction.
Materials and methods: Sixty-nine patients were randomly divided into two groups that were treated using the single-cone technique with BioRootTM RCS (Septodont) (BIO group) or warm vertical compaction with gutta-percha and ZOE sealer (PCS group). Two subsamples (BIOAP and PCSAP) comprised the cases with apical periodontitis. Treatment was undertaken by four residents using a standardized instrumentation and disinfection protocol. The periapical index (PAI) was recorded, and clinical and radiographic follow-up performed at 1, 3, 6, and 12 months. Treatment success was assessed according to "periapical healing" and "tooth survival". The test for the equality of proportions, t tests for the equality of means, and non-parametric K-sample tests for the equality of medians were applied when appropriate.
Results: The survival rate was similar in the BIO and PCS (p = 0.4074) and the BIOAP and PCSAP groups (p = 0.9114). The success rate was higher in the BIO groups, but not statistically significant (p = 0.0735). In both BIOAP and PCSAP groups, a progressive decrease in the PAI was observed.
Conclusion: At 12 months, both techniques showed reliable results. Further studies and longer follow-ups are needed.
Clinical relevance: This study documents the feasibility of using a bioactive sealer in conjunction with the single-cone technique to obturate the root canal and obtaining a predictable outcome.
Trial registration: ClinicalTrials.gov Identifie: NCT04249206.
Keywords: Bioactive sealers; Endodontic outcome; Root canal obturation; Single cone.