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下颌后牙种植体植入神经阻滞与浸润技术的麻醉效果和安全性比较。

2026年10月4日 更新者:Adrià Jorba García、University of Barcelona

下颌后牙种植体植入神经阻滞与浸润技术的麻醉效果和安全性比较。三盲随机临床试验。

The goal of this triple blind randomized clinical trial is to compare the safety, efficacy and postoperative pain between the inferior dental nerve block (IDNB) and the infiltrative technique (TINF) in the placement of mandibular posterior dental implants in patients with partial edentulism.

The main questions it aims to answer are:

  • The anesthetic efficacy of the IDNB technique, measured as the number of reanesthesias during the surgical procedure, is superior to the infiltrative technique in the placement of dental implants in the posterior mandibular area.
  • The IDNB technique presents a higher rate of adverse effects than TINF in the placement of dental implants in the posterior mandibular area.
  • The IDNB technique presents less postoperative pain than TINF in the placement of dental implants in the posterior mandibular area.

The investigator (XA) will perform the anesthetic technique. A modified dental anxiety questionnaire (MDAS) will be administered prior to surgery. Then, 2g of Amoxicillin will be administered 1 hour before the surgery. Subsequently, the surgeon and his assistant will prepare the surgical field with sterile sizes. The surgeon and assistant will then leave the operating room and the study investigator in charge of anesthetizing the patients (XA) will enter.

The anesthesia will be performed by an investigator other than the surgeon performing the procedure. The patient will be assigned to a treatment group; patients in the control group will undergo vestibular and lingual infiltration, while the experimental group will undergo IDNB together with buccal nerve block.

The anesthetic latency time will be determined by using a pulpometer on the most posterior tooth in the arch.

Failure to achieve sufficient anesthetic depth, as measured by pulpometer, within 6 minutes of the last puncture will be considered early anesthetic failure and will be counted as such.

  • Subsequently, a student of the Master's Degree in Oral Surgery of the University of Barcelona will perform the surgical intervention. The surgeons in charge of performing the surgery will not know to which group each patient belongs.
  • The collection of the variables and the postoperative controls will be carried out by the researcher who has not performed the anesthetic technique and who will not know the study group to which the patient belongs.

研究概览

研究类型

介入性

注册 (估计的)

42

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。

学习地点

    • Barcelona
      • L'Hospitalet de Llobregat、Barcelona、西班牙、08907
        • Hospital odontológic de Bellvitge, Universitat de Barcelona

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 及以上 (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:

  • Patients of legal age (≥18 years), partially edentulous, requiring the placement of one or more mandibular implants in the molar area.
  • Patients without relevant systemic pathology (equal or lower than ASA II).
  • Sufficient intellectual capacity to understand the study, the informed consent and to adequately complete the questionnaires.

Exclusion Criteria:

  • - Pregnant patients.
  • Patients with allergy or hypersensitivity to articaine or adrenaline.
  • Patients with uncontrolled systemic diseases.
  • Patients who may recognize the anesthetic technique used (e.g. dentists).
  • Drugs or systemic diseases (ASA III or higher) that contraindicate surgical intervention or the use of anesthetics and/or vasoconstrictors.
  • Patients with relative or absolute contraindication of conventional analgesic or anti-inflammatory regimen.
  • Immediate implants.
  • Surgeries requiring bone grafts.

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:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:三倍

武器和干预

参与者组/臂
干预/治疗
实验性的:Inferior dental nerve block

One articaine cartridge (1.8 mL of articaine 4% at 1:100,000) with the direct technique for the inferior dental nerve block and half a cartridge (0.9 mL) for the buccal nerve block.

The surgeon and his assistant will leave the operating room and the study investigator in charge of anesthetizing the patients (XA) will enter.

The anesthesia will be performed by an investigator other than the surgeon performing the procedure. The patient will be assigned to a treatment group; patients in the control group will undergo vestibular and lingual infiltration, while the experimental group will undergo inferior dental nerve block together with buccal nerve block.

有源比较器:Infiltrative

One anesthetic cartridge (1.8 mL of articaine 4% 1:100,000) using the vestibular infiltrative technique (supraperiosteal paraapical). Subsequently administer half a cartridge of anesthetic (0.9 mL of articaine 4% 1:100,000) using the infiltrative technique (supraperiosteal paraapical) lingually in the sublingual area of the tooth to be treated.

The surgeon and his assistant will leave the operating room and the study investigator in charge of anesthetizing the patients (XA) will enter.

The anesthesia will be performed by an investigator other than the surgeon performing the procedure. The patient will be assigned to a treatment group; patients in the control group will undergo vestibular and lingual infiltration, while the experimental group will undergo inferior dental nerve block together with buccal nerve block.

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
To compare the efficacy of the inferior dental nerve block and the infiltrative technique in the placement of mandibular posterior dental implants in patients with partial edentulism.
大体时间:1 hour

Determined by: Reporting a negative response to the pulpometer within 6 minutes after injection. Absence of need for reanesthesia during the surgical procedure.

1 hour

次要结果测量

结果测量
措施说明
大体时间
To evaluate the safety of anesthetic techniques used in the placement of dental implants in the posterior mandibular region.
大体时间:7 days

Determined by the appearance or absence of adverse effects, such as : Disorientation, dizziness, blurred vision, nausea, vomiting, tremors, convulsions, vasovagal syncope, paresthesia or trismus.

7 days
To analyze the postoperative pain associated with the placement of mandibular implants using an inferior dental nerve block compared to those implanted with infiltrative techniques.
大体时间:7 days

Determined using a visual anlogical scale of 10 cm at the 2, 6, and 12 hours posteriors to the surgery and then everyday until the 7 days

7 days

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。

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。

一般刊物

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 (实际的)

2024年11月5日

初级完成 (实际的)

2026年6月10日

研究完成 (估计的)

2026年12月1日

研究注册日期

首次提交

2024年10月11日

首先提交符合 QC 标准的

2024年10月11日

首次发布 (实际的)

2024年10月15日

研究记录更新

最后更新发布 (实际的)

2026年10月6日

上次提交的符合 QC 标准的更新

2026年10月4日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • 23-2024

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

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