EVALUATION OF THE EFFECT OF RECIPROCATING AND ROTARY NICKEL-TITANIUM FILE SYSTEMS USED IN COMBINATION WITH XP-ENDO FINISHER ON POSTOPERATIVE PAIN FOLLOWING ROOT CANAL TREATMENT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
The aim of root canal treatment is to prevent infection in teeth with pulp exposed to the oral environment due to caries or trauma, or in teeth with periapical lesions, by applying mechanical shaping, irrigation, and disinfection. Successful endodontic treatment depends on shaping the root canal system within biological limits, effective disinfection, hermetic obturation, and completion of restoration with an appropriate coronal restoration. For this purpose, mechanical preparation and irrigation solutions are used together.
The criteria under the operator's control in root canal treatment include factors that determine treatment success. These include infection control, proper application of canal shaping techniques, and effective distribution of intracanal medicaments and cleaning solutions. In particular, the mechanical shaping stage plays a critical role in removing microorganisms and tissue debris within the canal system. The removal of infected pulp tissue, bacteria, and necrotic debris without causing damage to the periradicular area is an important part of treatment. In this way, the spread of infection is prevented and treatment success is increased. Maintaining apical constriction during preparation and preventing extrusion of debris, bacteria, and irrigants from the apical region is very important. Extruded materials may cause increased inflammation, postoperative pain, and delayed periapical healing. Therefore, controlling irritants originating from the apical region and preventing extrusion increases treatment success.
Root canal preparation instruments have undergone significant changes over time and have made important progress with technological developments in the last 25-30 years. During root canal preparation, various instruments are used. These include stainless steel hand files (K-type files, Hedström files, reamers), low-speed instruments (Peeso, Gates Glidden), motor-driven NiTi rotary files, reciprocating NiTi endodontic motors and files, and ultrasonic instruments. These instruments provide different advantages in shaping and cleaning the root canal.
Traditionally, root canal shaping is performed using stainless steel hand instruments manufactured according to ISO (International Organization for Standardization) standards with a 0.02 taper. The variability among stainless steel hand files is achieved through differences in cutting blade angle, depth, cross-sectional design, and tip modifications. Stainless steel hand files generally have 16 mm of cutting blades, and for each 1 mm, the diameter increases by 0.02 mm. In addition, tip designs differ in terms of cutting efficiency. K-type files are used with quarter-turn and pull motion, while Hedström files are used only with pull motion. The disadvantages of stainless steel hand instruments include lack of elasticity. Therefore, they may cause operator-related errors, especially in curved canals. In addition, low taper angles may make it difficult to properly shape the canal from apical to coronal direction. This may lead to apical extrusion of debris during canal shaping and reduced effectiveness of irrigating agents.
Since the beginning of the 20th century, various motor-driven systems have been developed after hand instruments to facilitate shaping and cleaning procedures. In the early 1960s in the United States, metallurgist Buehler investigated non-magnetic and waterproof alloys and developed NiTi alloys. NiTi alloys differ from other alloys with four properties:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-65 years. Healthy volunteers. Mandibular molar teeth with pulpal necrosis, asymptomatic status, chronic apical periodontitis, and periapical radiolucent lesion.
- •Written informed consent.
排除标准
- •Patients who have taken analgesic or anti-inflammatory drugs within the last 12 hours.
- •Patients with allergy to non-steroidal anti-inflammatory drugs or local anesthetics.
- •Pregnant or lactating patients. Patients with a history of gastrointestinal diseases. Patients using opioid medications. Teeth with calcified canals, resorptive defects, or complex root canal anatomy. Patients with severe periodontal disease. Patients with acute or chronic apical abscess or signs of systemic infection. Immunosuppressed patients.
研究者
BUSRA OZTURK
Research Assistant
Eskisehir Osmangazi University