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临床试验/NCT06501703
NCT06501703已完成不适用

The Impact Of Different Final Irrigation Activation Techniques On Postoperative Pain In Single Rooted Mandibular Premolar Teeth: A Randomized Clinical Trial

Sinai University2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年6月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
2
主要终点
The Impact Of Different Final Irrigation Activation Techniques On Postoperative Pain

研究概览

简要总结

The trial was conducted to assess the impact of passive ultrasonic irrigation, XP endo finisher, AF max file, and manual dynamic agitation on postoperative pain and analgesic consumption at 6 h., 12 h., 24 h., 48 h., 72 h., and a week later on single-rooted lower premolar teeth with acute irreversible pulpitis and apical periodontitis.

详细描述

Selection of cases:

A total number of sixty-four patients in the 18-40 age range will be enrolled for the study from the outpatient clinic of restorative department of Sinai university (Kantara branch). The selected patients will have a carious pulp exposure that will be selected according to the inclusion and exclusion criteria to participate in this study. the procedure, possible discomfort and benefits will be explained to the patients. Informed consent will be obtained from the patients prior to study which includes root canal treatment in a single visit of single rooted mandibular premolar teeth with carious pulp exposure and symptomatic irreversible pulpitis with apical periodontitis, and both verbal and written consent is advisable. Before initiation of treatment, the whole procedural steps will be explained to the patients. Then the patients will sign an informed consent form.

Sample size:

Sample size calculation was performed using G*Power version 3.1.9.7 based on the results of a previous study) (13). 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 (0.55) calculated based on the results of a previous study. The predicted sample size (n) will be (64), i.e., 16 samples per group. To detect for different postoperative pain between groups Patient Selection Criteria Systemically healthy patients with single rooted mandibular premolar teeth with oval canals diagnosed with carious pulp exposure and symptomatic irreversible pulpitis with apical periodontitis will be included in the study. The diagnosis will be based on clinical findings, including pain level and its characteristics, intensity, duration, frequency, and provoking and relieving factors. Intraoral clinical examination had revealed either extensive restoration or a history of significant caries. Digital periapical x-rays had been used to assess the following factors: tooth structure, extensive caries, improper fillings, periapical tissue condition, and periodontal support. Whenever the regular x-rays disclosed participants with doubt of more than one canal, cone beam computed tomography (CBCT) was used to exclude. The inclusion guidelines for individuals' restorable teeth with a normal periodontal score index of less than two were as follows: severe preoperative pain (Vas score 3), discomfort response on biting/mastication or percussion but no mobility. Discomfort response on palpation of surrounding tissue but with no intraoral swelling. The inclusion criteria also include patients who stopped medications for the last 12 hours before the procedure. Additionally, the radiograph showed only normal or slight widening in the periodontal ligament space of the affected root. The exclusion criteria included patients with any serious systemic disease, those under the age of eighteen or incapable of giving informed consent, those over forty, those with severe preoperative pain on biting/mastication or percussion, those with a mandibular premolar involving multiple canals or huge periapical pathosis, open apices, periodontal involvement, retreated cases, sinus tract presence, and swelling of surrounding soft tissues; in addition to those, patients who had been pregnant and allergic patients with local anesthetic agents.(15) All participants will be informed about the study, and their consent will be obtained before treatment. A list for random participant assignment will be generated by a randomization software. This randomization will be performed by an operator not involved in the study. An ethyl chloride cold pulp tester will be used to detect the affected tooth's response and the adjacent and contralateral teeth (used as control) to ensure that the tester will work properly and that the participants responds adequately. The preoperative pain level will be assessed by giving each participant a pain scale chart (VRS) to record the pain level before any intervention. Clinical and radiographic data of each patient will be attached to their clinical notes Preparation of the patient: - Before the preparation and restoration visit, all patients will be subjected to full mouth scaling and will be given proper oral hygiene instruction.

Clinical Steps

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)

盲法说明

double (participants ,outcome assessors)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • solitary-rooted lower premolar teeth with acute irreversible pulpitis and apical periodontitis who were in the age range between 18 and 40 years old.
  • Each patient received root canal treatment in one session.
  • restorable teeth with a normal periodontal score index of less than two
  • severe preoperative pain (Vas score 3)
  • discomfort response on biting/mastication or percussion but no mobility.
  • Discomfort response on palpation of surrounding tissue but with no intraoral swelling.
  • Patients who stopped medications for the last 12 hours before the procedure
  • The radiograph showed only normal or slight widening in the periodontal ligament space of the affected root.

排除标准

  • patients with any serious systemic disease
  • Patients under the age of eighteen or incapable of giving informed consent
  • Patients over forty
  • Patients with a mandibular premolar involving multiple canals or huge periapical pathosis
  • Patients with severe preoperative pain on biting/mastication or percussion
  • Mandibular premolar with open apices
  • Mandibular premolar with periodontal involvement
  • Retreated cases, sinus tract presence, and swelling of surrounding soft tissues
  • patients who had been pregnant and allergic patients with local anesthetic agents

结局指标

主要结局

The Impact Of Different Final Irrigation Activation Techniques On Postoperative Pain

时间窗: 6, 12, 24, 48, 72 hours and I week after completion of root canal treatment.

Patients will be informed about the possible development of pain. Postoperative pain will be assessed using a VRS 6, 12, 24, 48, 72 hours and I week after completion of root canal treatment. The VRS consisted of a four-step pain scale using a continuous 0-3 point scale; No pain (0): the treated tooth felt normal. Patients did not have any pain or discomfort, mild (1): recognizable, not discomforting), moderate (2): discomforting, but bearable, and severe (3): considerable discomfort, difficult to bear. Each participant will be given a chart to record the level of postoperative pain and the frequency rate of the analgesic intake.

次要结局

未报告次要终点

研究者

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

Yasmin Tawfik Mohamed Sobh

Endodontic lecturer

Sinai University

研究点 (2)

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