Regenerative endodontic procedures for the treatment of necrotic mature teeth: A preliminary randomized clinical trial.

Abstract

This preliminary randomized, prospective, controlled trial aimed to compare the clinical and radiographic outcomes of two regenerative endodontic procedures (REPs), revitalization and a platelet-rich fibrin (PRF)-based technique, in the treatment of mature permanent teeth with necrotic pulps. The trial has been reported according to the Preferred Reporting Items for Randomized Trials in Endodontics 2020 guidelines. The study protocol was registered at the clinical trial registry (ClinicalTrials.gov) with identifier number NCT04158232. Twenty patients with mature necrotic anterior teeth with large periapical lesions were randomly allocated into two groups (n=10): group I, treated with revitalization with the blood clot (BC) technique and group II, treated with a PRF-based technique. The follow-up was for 12months. Periradicular healing was assessed using standardized radiographs taken at baseline, and at 6 and 12months after treatment. An electric pulp tester was used to assess whether pulp sensibility had been regained during the follow-up period. Statistical analysis was conducted using Mann-Whitney test and Wilcoxon test for non-parametric data. For parametric data, repeated measures analysis of variance was used. The significance level was set at p≤.05. There was a significant increase in periradicular healing in both groups at 6 and 12months, compared to that at baseline, with no significant difference between the studied groups after 12months (p=.143). There was a significant difference between the tooth sensibility readings at baseline, 6-month and 12-month follow-up timepoints (p<.001). The findings of this preliminary trial indicate the potential for using REPs, such as revitalization or PRF-based techniques, as treatment options for mature teeth with necrotic pulps. A higher level of evidence obtained through adequately powered clinical trials and longer follow-up periods are required to conclusively validate the different outcomes of REPs.