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Effect of Manual Glide Path Establishment on Endodontic Postoperative Pain

2022年1月11日 更新者:Heba Elasfouri、Cairo University

Effect of Manual Glide Path Versus Mechanical Glide Path Establishment on Endodontic Postoperative Pain. A Randomized Clinical Trial

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.

In group A manual glide path will be established using manual thermal treated stainless-steel files in a watch winding maneuver. In group B glide path will be established using rotary Ni-Ti files in a reciprocating maneuver. Coronal flaring will be performed using Gates Glidden drill #3 in a brushing motion away from dangerous zone. 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 were irrigated again with 10ml 1.5% NaOCl, which was delivered 2mm coronal to apical canal terminus. Irrigation was hydro-dynamically agitated with EndoActivator device (Dentsply Maillefer, Baillagues, Switzerland) using blue tips #30/06 inserted 2mm short of working length for 60 seconds.

研究概览

详细说明

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.

In group A manual glide path will be established using manual thermal treated stainless-steel files in a watch winding maneuver. In group B glide path will be established using rotary Ni-Ti files in a reciprocating maneuver. Coronal flaring will be performed using Gates Glidden drill #3 in a brushing motion away from dangerous zone. 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 were irrigated again with 10ml 1.5% NaOCl, which was delivered 2mm coronal to apical canal terminus. Irrigation was hydro-dynamically agitated with EndoActivator device (Dentsply Maillefer, Baillagues, Switzerland) using blue tips #30/06 inserted 2mm short of working length for 60 seconds. Root canals will be shaped using ProTaper next rotary Ni-Ti files (Dentsply Maillefer, Baillagues, Switzerland). 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.

研究类型

介入性

注册 (预期的)

32

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 70年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 1. The offending tooth has previous attempt of pulp therapy or root canal treatment.
  • 2. The patient showing any clinical or radiographic evidence of periapical pathosis.
  • 3. Patients received analgesics or systemic antibiotic prior to treatment.

    -.4 Immunocompromised patients.

  • 5. Any unknown infectious disease (e.g. HBV, HCV, HIV, or T.B.)
  • 6. History of cancer with radio or chemotherapy.
  • 7. Offending molar with mobility score ≥2.
  • 8. Offending molar with pocket depth ≥6mm.
  • 9. Immature molars.
  • 10. Nonodontogenic pain.
  • 11. Patients with more than one tooth requiring endodontic intervention.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的:Manual glide path
manual glide path will be established using manual thermal treated stainless-steel files in a watch winding maneuver
manual glide path will be established using manual thermal treated stainless-steel files in a watch winding maneuver. . Coronal flaring will be performed using Gates Glidden drill #3 in a brushing motion away from dangerous zone.
实验性的:mechanical glide path
glide path will be established using rotary Ni-Ti files in a reciprocating maneuver
glide path will be established using rotary Ni-Ti files in a reciprocating maneuver. Coronal flaring will be performed using Gates Glidden drill #3 in a brushing motion away from dangerous zone.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
postoperative pain
大体时间:after 4 hours after root canal treatment
postoperative pain after root canal treatment using VAS
after 4 hours after root canal treatment
postoperative pain
大体时间:after 6hours after root canal treatment
postoperative pain after root canal treatment using VAS
after 6hours after root canal treatment
postoperative pain
大体时间:after 12hours after root canal treatment
postoperative pain after root canal treatment using VAS
after 12hours after root canal treatment
postoperative pain
大体时间:after 24hours after root canal treatment
postoperative pain after root canal treatment using VAS
after 24hours after root canal treatment
postoperative pain
大体时间:after 48 hours after root canal treatment
postoperative pain after root canal treatment using VAS
after 48 hours after root canal treatment

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

合作者

调查人员

  • 研究主任:Heba A ElAsfouri、Cairo University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2022年6月1日

初级完成 (预期的)

2022年9月1日

研究完成 (预期的)

2022年9月1日

研究注册日期

首次提交

2021年12月26日

首先提交符合 QC 标准的

2022年1月11日

首次发布 (实际的)

2022年1月25日

研究记录更新

最后更新发布 (实际的)

2022年1月25日

上次提交的符合 QC 标准的更新

2022年1月11日

最后验证

2022年1月1日

更多信息

与本研究相关的术语

其他研究编号

  • 26-12-2021

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Manual glide path的临床试验

3
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