跳至主要内容
临床试验/NCT04465149
NCT04465149已完成不适用

Comparative Study of the Anaesthetic Efficacy of 4% Articaine Versus 2% Mepivacaine in Mandibular Third Molar Germectomy Using Different Anaesthetic Techniques: a Split-mouth Clinical Trial

University of Campania "Luigi Vanvitelli"2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年6月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Discomfort/Pain felt for anesthetic injection valued by the Patient on a Visual Analogue Scale

研究概览

简要总结

Aim: To compare the clinical efficacy of local anaesthetics with articaine 4% or mepivacaine 2% (both with epinephrine 1:100.000) using different anaesthetic techniques to perform germectomy of lower third molars and to assess patients' feelings and pain during surgery.

Methods: 50 patients (ranged 11-16 years) who required germectomy of mandibular third molars were recruited. Each patient received local anaesthesia on one side with articaine inoculated with plexus technique while on the other side with mepivacaine using inferior alveolar nerve block technique. The patients' evaluation was performed on pre and intraoperative tactile-pressure feelings and intraoperative pain with four levels on the analogic visual scale (VAS).

详细描述

The surgical extraction of a tooth that exhibits at least a third of its root in formation, with a periodontal ligament discernible on panoramic x-ray, is defined as germectomy. Early germectomy is a usefull intervention to avoid problems caused by lower third molar retention and impaction, and it is often required before or after orthodontic treatment. This surgical technique would also allow to avoid complications, such as inferior alveolar and lingual nerve damage.

The control of the patient's pain and anxiety by using local anaesthesia is essential in oral surgery: these aspects become more important in adolescents, above all in the case of third molar germectomy. Local anaesthetic (LA) injection is often the only painfull part of the dental procedure, and the fear associated with this technique is the main reason that leads patients to avoid dental treatment.

During the execution of dental surgical procedures, anaesthesia of the structures innervated by the mandibular nerve is necessary, and many local anaesthetic techniques are described in the literature. Generally, infiltration plexus technique is usually performed for maxillary procedures while IANB is used for molar mandibular sites with 2% local anaesthetics. Failure rates for IANB are high, sometimes reaching 80% for the lower incisors with this technique, and numerous approaches for the implementation of a new technique of IANB have been described. Among them, the articaine 4% already has been successfully used to achieve local anesthesia and facial infiltration anaesthetic technique in the mandible showed efficacy with encouraging result that can be overlapped to the IANB technique. Articaine (4-methyl-3-[2-(propylamino)-propionamido]-2-thiophene-carboxylic acid, methyl ester hydrochloride) contains a thiophene ring instead of benzene and an ester group. The thiophene ring allows for higher lipid solubility so a greater portion of an administered dose can enter in neurons. Gazal found that a combination of nerve block anaesthesia, buccal infiltration and intra-ligamentary injection resulted in more profound anaesthesia (P =0.003) and higher success rates compared to IANB alone in mandibular first molar pulp anaesthesia. Other studies reported the use of articaine in implantology interventions in which it was used with subperiosteal technique on the buccal and vestibular sides.

Thus, the literature showed several conflicting results on the mandibular facial plexus infiltration technique used with different anesthetics.

Recent studies of this anaesthetic technique found that 1.8 cc of 4% articaine facial infiltration in the mandible can be effective when the thickness of mandibular facial cortex is < 2.0-3.0 mm, with 5-10 minutes needed for the adequate anaesthesia.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
11 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients requiring bilateral germectomy of mandibular third molars before orthodontic treatment

排除标准

  • Patients presenting systemic and oral diseases

结局指标

主要结局

Discomfort/Pain felt for anesthetic injection valued by the Patient on a Visual Analogue Scale

时间窗: At the beginning of Surgery

Once performed the injections, patients were asked to notice on a visual analogue scale, how much discomfort they felt due to the anaesthetic injections, indicating one of the following values: 0 absent 1. mild 2. moderate 3. severe

次要结局

  • Test during the Surgery(After 10/15 minutes)

研究者

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

Alfredo De Rosa

Associated Professor

University of Campania "Luigi Vanvitelli"

研究点 (2)

Loading locations...

相似试验