Assessing the influence of KatanaTM Cleaner on the clinical performance of bulk-fill restorations in endodontically treated teeth: study protocol for a randomized clinical study

Abstract

Background Complete cleaning of the pulp chamber is mandatory prior to restoration. Ethanol is the commonly used cleaning agent; however, studies report its inefficiency in completely removing residues. Although Katana is recommended for prosthetic purposes, studies on its use as a pulp chamber cleaning agent have shown promising results; moreover, it has the potential to improve dentin bonding strength. This study aimed to conduct a prospective, controlled, equivalence trial to evaluate the effectiveness of the Katana™ Cleaner in cleaning the pulp chamber of endodontically treated teeth and to assess its impact on the clinical performance of bulk-fill resin restorations. Methods This will be a parallel, randomized, double-blind clinical trial conducted in accordance with the CONSORT guidelines. Based on the type of sealer (epoxy or bioceramic cement) and the cleaning agent used, the patients (n = 224) will be divided into four treatment groups, and the final restoration will be done using bulk-fill resin. The clinical performance of the restorations will be assessed by an experienced, calibrated dentist who is not involved in the restorative procedures. Clinical performance evaluations will be conducted immediately and after 6, 12, and 18 months, using two assessment criteria: World Dental Federation (FDI) and United States Public Health Service (USPHS). Kaplan–Meier survival and Cox regression analyses will be used to determine the occurrence of failure over time and the risk of failure in both treatment types, respectively. The significance level for all tests will be set at 5%. Discussion This study will be the first to examine the clinical effects of a new cleaning protocol for the removal of endodontic cement residue. Moreover, this study will explore whether the use of Katana improves the bonding strength of a self-conditioning adhesive to dentin in teeth restored with composite resin. If clinical studies yield promising results, individuals would benefit from interventions using the proposed protocol, thereby leading to an improved prognosis of endodontically treated tooth restorations, prompting further research. Trial registration: REBEC: RBR-86ycwq7 on February 29, 2024.