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临床试验/NCT04728386
NCT04728386Unknown不适用

Assessment of Postoperative Pain and Antibacterial Efficacy After Root Canal Irrigation With Curcumin Versus Sodium Hypochlorite in Patients With Necrotic Mandibular Molars: Randomized Clinical Trial

Cairo University0 个研究点目标入组 38 人开始时间: 2021年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
38
主要终点
postoperative pain at 8 hours

研究概览

简要总结

This study aims to compare the effect of 2% curcumin solution versus 2.5% sodium hypochlorite as irrigating solutions in necrotic mandibular molars in terms of postoperative pain and antibacterial effect.

详细描述

patients with necrotic mandibular molars will be selected

  1. Diagnostic procedures:
  • Personal information (name, age, gender, address and phone number), full medical and dental histories using schematic charts will be obtained from all patients participating in this research.
  • History of chief complaint will be obtained in the dental history chart.
  • Clinical and radiographic evaluation for each tooth included in this study will be recorded. The tooth will be examined for presence of extensive caries or pulp exposures. Soft tissue examination and tooth mobility evaluation will be done by percussion and palpation.
  • Extraoral examination will be performed by visual inspection of the face and neck and palpation for any swollen lymph nodes.
  • Each tooth will be evaluated for sensitivity using electric pulp tester. Diagnosis will also be confirmed by the absence of bleeding after access cavity preparation.
  • Final Diagnosis: Mature mandibular asymptomatic necrotic molars with normal periapical radiographic appearance.
  • The operator will explicitly explain the trial steps to the patients, and an informed consent will be signed by patients who accept enrollment.
  • Pain scale chart will be given to each patient to rate his /her pain level before endodontic treatment as preoperative reading using a Numerical Rating Scale (NRS).
  1. Endodontic procedures:
  • All the performed steps of root canal treatment will be included in the chart of endodontic procedures.
  • The tooth will be isolated with rubber dam to maintain aseptic field, after isolation the tooth and surrounding field will be disinfected by a protocol using 3% hydrogen peroxide and 2.5% sodium hypochlorite before and after coronal access cavity preparation.
  • The initial sample S1 will be collected from root canals before preparation using sterile paper points. Each root canal will be dried with 3 sterile paper points ISO# 15 which will be left inside the root canal for 1 minute each with pumping movements to generate a suspension with bacteria of the main pulpal area.
  • The paper points will be immediately placed in sterile test tubes containing reduced transport medium of thioglycolate and sent to the Microbiology Laboratory, Faculty of Medicine, Cairo University for microbiologic processing to be cultured within one hour.
  • Root canals will be mechanically prepared in a crown-down approach using ProTaper Universal NiTi files in an X-Smart endodontic motor according to the manufacture instructions.
  • The canals will be thoroughly irrigated between every two subsequent files using 2 ml of 2.5% NaOCl using a side vented needle (gauge 29) to control the possibility of irrigant apical extrusion.
  • After complete root canal preparation all canals will be flushed with 17 % EDTA followed by sterile saline.
  1. Random allocation:
  • According to the randomization sequence, after complete root canal preparation patients will be assigned to one of 2 groups:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Patient's age between 18-50 years.
  • Male and female.
  • Systemically healthy patients (ASA I or II).
  • Mature mandibular molar teeth with: Necrotic pulps, normal periapical radiographic appearance and no intra-canal calcifications or internal resorptive lesions

排除标准

  • Medically compromised patients having substantive functional limitations (ASA III or IV).
  • Patients having two or more adjacent teeth requiring endodontic treatment.
  • Patients who received antibiotic therapy within the last three months before treatment.
  • Patients administered analgesics in the last 24 hours before treatment.
  • Teeth with:
  • Vital pulps.
  • Immature apices.
  • Acute periapical abscess, swellings and facial cellulitis.
  • Periodontally hopeless (mobility grade II or III).
  • Previous root canal treatment.
  • Non-restorable coronal portion.
  • TMJ problems, bruxism or traumatic occlusion.
  • Inability to perceive the given instructions

结局指标

主要结局

postoperative pain at 8 hours

时间窗: 8 hours

recorded by 11-point NRS scale with scores from 0 to 10, with 0 for having no symptoms and 10 having worst imaginable symptoms. Pain levels will be categorized as follows: * 0 = no pain. * 1-3= mild pain. * 4-6= moderate pain. * 7-10= severe pain. scale with scores from 0 to 10, with 0 for having no symptoms and 10 having worst imaginable symptoms. Pain levels will be categorized as follows: * 0 = no pain. * 1-3= mild pain. * 4-6= moderate pain. * 7-10=severe pain

postoperative pain at 24 hours

时间窗: 24 hours

recorded by 11-point NRS scale with scores from 0 to 10, with 0 for having no symptoms and 10 having worst imaginable symptoms. Pain levels will be categorized as follows:

postoperative pain at 48 hours

时间窗: 48 hours

recorded by 11-point NRS scale with scores from 0 to 10, with 0 for having no symptoms and 10 having worst imaginable symptoms. Pain levels will be categorized as follows:

次要结局

  • antibacterial effect(during treatment)

研究者

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

Eman Medhat

post graduate student

Cairo University

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