Periodontitis Clinical Trials

Title Evaluation of the Effect of Reciprocal and Rotational NiTi File Systems and XP-Endo Finisher Combination on Postoperative Pain Clinical Research Protocol Summary Objective The aim of this study is to compare the effects of different NiTi file systems (FKG Race Evo and One Reci) and their combination with XP-Endo Finisher on postoperative pain. The study intends to evaluate how these two different file systems and XP-Endo Finisher influence patients' pain levels after endodontic treatment. It is also hypothesized that XP-Endo Finisher may play an important role in reducing postoperative pain by enhancing irrigation efficacy. This study is expected to contribute clinically significant findings to the limited literature on this topic. Background Endodontic treatment is a procedure performed to mechanically shape, disinfect, and hermetically seal teeth with pulpal damage or periapical lesions caused by caries or trauma. The success of treatment depends on proper shaping within biological limits, effective disinfection, preservation of apical constriction, and removal of bacteria from canal walls. NiTi alloys have improved canal shaping efficiency due to their flexibility and shape memory properties. Rotary and reciprocating NiTi systems each offer different clinical advantages. Rotary systems provide efficient shaping through continuous rotation, while reciprocating systems offer a minimally invasive approach using a single file. Postoperative pain is a common complication after endodontic treatment and may vary depending on instrumentation technique, irrigation protocol, and clinical conditions. Irrigation is essential for removing microorganisms and debris from the canal system. Conventional irrigation techniques may be insufficient to reach apical areas effectively. Therefore, advanced systems such as XP-Endo Finisher have been developed to improve irrigant penetration and enhance cleaning efficiency. FKG Race Evo is a rotary NiTi system with high cyclic fatigue resistance, while One Reci is a reciprocating single-file system that offers safe shaping with reduced procedural errors. This study will evaluate the postoperative pain outcomes of these systems in combination with XP-Endo Finisher. Materials and Methods The materials used in this study include FKG Race Evo and One Reci NiTi file systems, XP-Endo Finisher, 2.5% sodium hypochlorite (NaOCl), 17% EDTA, and saline solution. The study will be conducted on 80 patients attending the Department of Endodontics, Faculty of Dentistry, Eskisehir Osmangazi University. Healthy individuals aged 18-65 years with chronic apical periodontitis or periapical radiolucent lesions will be included. Written informed consent will be obtained from all participants. Patients will be randomly divided into four groups: Group 1: Instrumentation with FKG Race Evo 25/06 Group 2: FKG Race Evo 25/06 followed by XP-Endo Finisher irrigation Group 3: Instrumentation with One Reci 25/06 Group 4: One Reci 25/06 followed by XP-Endo Finisher irrigation All procedures will be performed under rubber dam isolation and local anesthesia. Canal shaping will be performed according to the assigned system, with irrigation performed after each file change. Obturation will be completed in the second session. Sample Size Calculation The sample size was calculated using G\*Power software (3.1.9.4; Heinrich Heine University, Düsseldorf, Germany). The calculation was based on a 5% type I error (alpha), 95% power (1-β), and an effect size of 0.587 (f), derived from a previous study. A total of 80 participants was determined to be sufficient to detect statistically significant differences between groups. Each group will include 20 patients. Statistical Analysis All data will be recorded electronically with strict confidentiality. Only authorized researchers will have access to the dataset. Statistical analysis will be performed using appropriate software. The choice of statistical tests will depend on data distribution. Study results may be published in national or international peer-reviewed journals in accordance with ethical and legal requirements. All data will be anonymized to protect participant confidentiality, and secure electronic storage will be used to prevent unauthorized access.