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临床试验/NCT07250399
NCT07250399招募中不适用

Effect of Instrumentation Kinematics on Intraoperative and Post-operative Pain in Maxillary Premolars With Acute Irreversible Pulpitis: A Randomized Clinical Trial

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2025年10月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
56
试验地点
1
主要终点
Intraoperative pain

研究概览

简要总结

Post-endodontic pain refers to the discomfort experienced following endodontic procedures. The incidence of post-operative pain is reported to be 25-40% regardless of the pulp and periradicular condition. It has been shown that pain prevalence declined from 40% in the first 48 h after treatment to 11% 7 days post-treatment. The mechanisms behind post-endodontic pain are complex and multifactorial that include host-dependent factors such as host immunity and preoperative pain history as well as operator-related factors such as chemical, mechanical or bacterial injury that occurs during endodontic procedure. A major contributor to this pain is the extrusion of infected debris as dentin chips, microorganisms, and the remnants of pulp tissue to the periradicular area. The intensity of pain is directly proportional to the extent of tissue injury caused.

During root canal preparation, a variety of materials including dentin debris, pulp remnants, microorganisms, endotoxins, and irrigating solutions may be extruded into the periapical tissues, potentially leading to inflammation, increased vascular permeability, oedema, nerve compression and postoperative pain. Studies suggest that apical extrusion is affected by file systems, file kinematics and instrumentation techniques used during root canal preparation .

Rotary systems vary in the amount of debris they extrude due to variations in cross-sectional design, flute depth, cutting blade, kinematics, taper, file sequence, tip size and cutting efficiency. Both rotary and reciprocating NiTi files are effective in reducing endotoxins and bacterial by-products from infected root canals. NiTi files enhance biomechanical preparation and canal centering and exhibit greater resistance to cycle fatigue due to their super elasticity and

greater flexibility. However, the extent of periapical inflammation may differ among NiTi systems due to variations in the amounts of extruded irritantsEdgeOne Fire reciprocating system (EdgeEndo, Albuquerque, New Mexico, USA) features a parallelogram cross-section having two cutting edges and an off-center design. these endodontic instruments are treated with a proprietary heat process called FireWire™, that it is claimed to provide high flexibility and a negligible restoring force. It operates using alternating cutting and releasing angles through a reciprocating motion; with an exchange in the direction of rotation.

Jizai rotary file systems (JZ) (MANI, Tochigi, Japan) is a recently developed NiTi rotary system made of a proprietary heat-treated NiTi alloy. JZ system exhibits bending deformation indicating that it is not purely austenitic but contains R-phase and/or martensite at room or body temperature. It has an off-center quasi-rectangular cross-section with a radial land on one of the short sides. According to the manufacturer, this cross-sectional design produces low screw-in forces owing to the radial land and provides wide spaces for debris removal. EdgeOne Fire reciprocating system (EdgeEndo, Albuquerque, New Mexico, USA) features a parallelogram cross-section having two cutting edges and an off-center design. these endodontic instruments are treated with a proprietary heat process called FireWire™, that it is claimed to provide high flexibility and a negligible restoring force. It operates using alternating cutting and releasing angles through a reciprocating motion; with an exchange in the direction of rotation.

Jizai rotary file systems (JZ) (MANI, Tochigi, Japan) is a recently developed NiTi rotary system made of a proprietary heat-treated NiTi alloy. JZ system exhibits bending deformation indicating that it is not purely austenitic but contains R-phase and/or martensite at room or body temperature. It has an off-center quasi-rectangular cross-section with a radial land on one of the short sides. According to the manufacturer, this cross-sectional design produces low screw-in forces owing to the radial land and provides wide spaces for debris removal.A systematic review of the literature suggested that debris extrusion is influenced by instrument kinematics . However, evidence is still conflicting and sometimes even contradicting regarding the association of kinematics with debris extrusion and post-operative pain.

详细描述

  1. Trial design:

This study will be a parallel randomized controlled trial a. It is written in accordance with the Preferred Reporting Items for Randomized Trial in Endodontics (PRIRATE) 2020 guidelines . 2. Participants:

Patients of age range between 20 and 50 years old from the outpatient clinic of Endodontic Department, Faculty of Dental Medicine for Girls, Al-Azhar University will participate in this study. These patients have maxillary premolar teeth with symptomatic pulpitis. Patients will be informed about all the study's procedures. They will be included in the study after fulfilling the inclusion criteria and sign an informed consent . The Visual Analog Scale (VAS) will be explained to all participants utilizing visual, verbal and numerical methods to ensure complete understanding. Training on its use will be provided after their recruitment and before randomization to ensure that participants are familiar with the scale before pretreatment pain assessment. 3. Sample size calculation:

Sample size calculation was performed using G*Power version 3.1.9.7 based on the results of a previous study (Kherlakian et al.) . A power analysis was designed to have adequate power to apply a two-sided statistical test to reject the null hypothesis that there is no difference between groups. By adopting an alpha level of (0.05) and a beta of (0.2), i.e. power = 80% and an effect size (d) of (0.826). The predicted sample size (n) was (50), i.e., 25 subjects per group. This number is increased to 28 subjects per group to compensate for a drop-out rate of 10%.

Criteria of patient selection:

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Maxillary first and second bi-rooted premolar teeth having type I root canal.
  • •have mature teeth with closed apex.
  • •Teeth with prolonged response to the pulp tests.
  • •Spontaneous pain (preoperative visual analog scale score )4-6).
  • •Teeth with normal periapical appearance.
  • •Restorable teeth.
  • •Patients who will be able to understand the informed consent form and pain recording scales used in the study will be included.

排除标准

  • 未提供

研究组 & 干预措施

Group I reciprocating system (EdgeOne Fire group)

Experimental

Root canal preparation will be completed using EdgeOne Fire reciprocating system (Albuquerque, NM, USA) up to size (35/0.04). Files will be operated at reciprocating motion, where the angle of reciprocation will be set at 150° counterclockwise (CCW) and 30° clockwise (CW).

干预措施: EdgeOne Fire reciprocating system (Device)

Group II rotary system (JZ file group)

Experimental

Root canal preparation will be completed using JZ file system up to size (35/0.04). The files will be operated at 300 rpm and 2 Ncm torque.

干预措施: JZ file system (Device)

结局指标

主要结局

Intraoperative pain

时间窗: immediately after root canal preparation

The evaluation of intraoperative pain will be conducted immediately after root canal preparation with each of the instrumentation kinematics using Visual Analog Scale (VAS). In each group, the patients will be asked to specify the level of pain for the buccal and palatal canals separately. The average of two values reported by the patient will be taken and then accepted as VAS value.

Postoperative pain

时间窗: 6,12,24,48,72 hours and 1 week

Postoperative pain will be recorded after 6,12,24,48,72 hours and 1 week of the treatment using Visual Analog Scale (VAS).

次要结局

  • Analgesic intake assessment(from immediately after the treatment to 1 week postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sabah Morad Sobhy

Endodontic department, al azhar university. principal investigator

Al-Azhar University

研究点 (1)

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