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临床试验/NCT05169879
NCT05169879Unknown不适用

Influence of Early Coronal Flaring Upon Postoperative Pain Following Root Canal Treatment. A Randomized Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2022年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
32
试验地点
1
主要终点
postoperative pain

研究概览

简要总结

The aim of this clinical study is to evaluate the influence of early coronal flaring upon postoperative pain following root canal treatment in a single session approach.

详细描述

All patients will be treated in a single session approach regardless of the group. All molars will be anesthetized either through infiltration in case of maxillary molars or inferior alveolar nerve block in case of mandibular molars using Octocaine 2% with epinephrine 1: 100,000 (Lidocaine HCl, Novocol Pharmaceutical, Ontario, Canada.). Rubber dam will be applied; and access will be opened using Endo access bur.

Canals will be scouted using manual patency file in a watch winding maneuver. In group A, ProGlider PG (size 16, .02 taper) instrument with a length of 25 mm will be used to the working length, then early coronal flaring will be performed using Gates Glidden drill #3 in a brushing motion away from dangerous zone. In group B no coronal flaring will be performed following minimally invasive approach.

Root canals will be copiously irrigated using 10 ml 2.5% sodium hypochlorite NaOCl (Clorox; Egyptian Company for household bleach, Egypt) delivered using 28 Gauge safety Steri Irrigation Tip (DiaDent Group International, Burnaby, BC, Canada) inserted 3 mm below cementoenamel junction. Working length will be determined using electronic apex locator Root ZX II (J. Morita Mfg. Corp, Kyoto, Japan) and confirmed radiographically using parallel technique with receptor holding device.

Canals will be irrigated again with 10ml 1.5% NaOCl, which will be delivered 2mm coronal to apical canal terminus. Irrigation will be hydro-dynamically agitated with EndoActivator device (Dentsply Maillefer, Baillagues, Switzerland) using yellow tips #15/02 inserted 2mm short of working length for 60 seconds. ProGlider PG (size 16, .02 taper) instrument with a length of 25 mm will be used to the working length. Root canals will be shaped using ProTaper next rotary Ni-Ti files (Dentsply Maillefer, Baillagues, Switzerland) till # X3 (Elnaghy et al. 2014). Each file will be used in one molar. Finally, Root canals will be obturated using cold lateral compaction technique. The molars will be permanently restored using composite resin restoration and will be scheduled for extra coronal restoration.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient age above 18-70 years old.
  • Both males and females will be included.
  • All patients are in a good health without systemic condition.
  • The offending tooth is a molar.
  • The offending molar is indicated for root canal treatment.
  • One molar for every patient.
  • All patients will sign an informed consent.

排除标准

  • Necrotic molars
  • The offending tooth has previous attempt of pulp therapy or root canal treatment.
  • The patient showing any clinical or radiographic evidence of periapical pathosis.
  • Patients received analgesics or systemic antibiotic prior to treatment.
  • Immunocompromised patients.
  • Any unknown infectious disease (e.g. HBV, HCV, HIV, or T.B.)
  • History of cancer with radio or chemotherapy.
  • Offending molar with mobility score ≥
  • Offending molar with pocket depth ≥6mm.
  • Immature molars.
  • Nonodontogenic pain.
  • Patients with more than one tooth requiring endodontic intervention

结局指标

主要结局

postoperative pain

时间窗: after 48 hours after treatment.

The pain level will be measured using a validated pain scale known as the Verbal Analogue scale

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

Heba Elasfouri

Associate professor

Cairo University

研究点 (1)

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