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临床试验/NCT06439186
NCT06439186已完成4 期

Infiltrative Anesthesia With Lidocaine Can Replace The Inferior Alveolar Nerve Block In Extraction of Devitalized Mandibular Molar Teeth

Konya Necmettin Erbakan Üniversitesi1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Visual analogue scale

研究概览

简要总结

Generally it is accepted that infiltrative anesthesia (IA) is not sufficient for extraction of lower molars and that an inferior alveolar nerve block (IANB) is needed. In this study, it was aimed to compare the effectiveness of IANB and IA in extraction of devitalized mandibular molars.

Sixty subjects are randomly divided into study (n=30) and control (n=30) groups. Lidocaine with epinephrine is used for all injections. In the study group only vestibular and lingual IA will be used. In the control group, IANB will be applied. Teeth were extracted as usual. The pain felt during extraction will be compared.

详细描述

It has been taught in dental curricula that using only infiltrative anesthesia (IA) is not sufficient for extraction of lower molars and that an inferior alveolar nerve block (IANB) is needed. However, it is also well-known that dental implants can be inserted into mandibular posterior region using only IA.

It can be claimed that there is no difference regarding the need for anesthesia between extracting a devitalized tooth and placing an implant in the same area. In this study, it was aimed to compare the effectiveness of IANB and IA in extraction of mandibular molars that had previously undergone root canal treatment.

The study is as a prospective, randomized, and non blinded clinical trial. All procedures are carried out at Necmettin Erbakan University, Faculty of Dentistry. The inclusion criteria are: age > 18 years, the tooth to be extracted is a mandibular first or second molar with a previously completed root canal treatment. The patients allergic to local anesthetics, those with severely mobile teeth, those had severe pain due to an acute infection, and the patients using psychotropic drugs are excluded.

Sixty subjects are randomly divided into study (n=30) and control (n=30) groups. An anesthetic solution containing 20 mg/mL of lidocaine and 0.0125 mg/mL of epinephrine was used in all subjects. In the study group only vestibular and lingual IA will be used. In the control group, IANB will be applied. The teeth will be extracted as usual. Using a visual analog scale (VAS), the pain felt during extraction will be separately recorded. Mann-Whitney U test will be used for statistical analysis. Statistical significance is defined as p<.05.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 62 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •the patient is older than 18 years
  • •the tooth to be extracted is a mandibular first or second molar with a previously completed root canal treatment

排除标准

  • •The patients allergic to local anesthetics
  • •Those with severely mobile teeth
  • •Those had severe pain due to an acute infection
  • •The patients using psychotropic drugs

研究组 & 干预措施

Anesthesia

Active Comparator

In the first group, inferior alveolar anesthesia is used. In the second group, infiltrative anesthesia is used.

In both groups, one dose of lidocaine HCl contained in 2 mL ampule is used. It is a standard drug.

干预措施: Lidocain (Drug)

tooth extraction pain

Active Comparator

In both groups, the patient is asked to evaluate the pain she/he experienced during the extraction. This evaluation is done immediately after the extraction, by using a "visual analogue scale" (detailed in other sections of this trial record).

干预措施: Lidocain (Drug)

结局指标

主要结局

Visual analogue scale

时间窗: Immediately after the tooth extraction.

This is a 100 mm linear scale used to measure pain. On the left end is a description: "No pain at all. On the right end, there is the description "The worst pain imaginable." The patient will be asked to mark the pain on this line and then the distance from the left end to the mark will be measured.

次要结局

未报告次要终点

研究者

发起方
Konya Necmettin Erbakan Üniversitesi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kubilay Isik

Professor

Konya Necmettin Erbakan Üniversitesi

研究点 (1)

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