Efficacy of a Guiding Device for Inferior Alveolar Nerve Block, EZ-Block®, Compared With a Conventional "Freehand" Administration, in Providing Anesthesia During Surgical Removal of Impacted Lower Third Molar.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 10
- 主要终点
- The success of the truncal infiltration of anesthetic product will be defined as the absence of recourse to additional anesthesia during the procedure
研究概览
简要总结
The success rates reported in the literature for the various truncal anesthesia techniques are extremely variable and have shown a lack of reproducibility of the techniques. The use of the EZ-BLOCK® guidance system would increase this success rate in a significant and reproducible way, as it is based on individualized anatomical foundations and therefore adapted to inter-patient variability.
In order to determine its effectiveness in clinical situations encountered in current practice, a comparative clinical study of the 2 techniques (freehand reference technique and using the EZ-BLOCK® system) is necessary.
详细描述
The use of loco-regional anesthesia in the mandibular foramen (Inferior Alveolar Nerve Block - IANB) is part of the therapeutic arsenal for any Dental Surgeon or specialist in Oral Surgery or Endodontics. These local-regional anesthesias are indicated for restorative, endodontic and single and/or multiple surgical treatments of mandibular teeth homolateral to the infiltrated side. The so-called "conventional" freehand reference technique was described by William Steward Halsted and compared in numerous studies to other truncal anesthesia techniques such as Gow Gates or even Akinosi-Vazirani.
Certain anatomical landmarks must be accurately identified by the operator to reduce the percentage of failure of this technique. Conventional IANB is associated with a 40% failure rate in surgical removal of the lower third molars included, which is the highest percentage of all clinical failures obtained under local anesthesia.
The purpose of this study is to compare the success rate of a IANB guidance device, EZ-Block®, with traditional freehand anatomic administration in the surgical removal of impacted lower third molars.
The use of the EZ-BLOCK® guidance system would increase the success rate significantly and reproducibly because it is based on individualized anatomical foundations and is therefore adapted to inter-patient variability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Investigator)
盲法说明
In each center, a pair of practitioners has been identified: one practitioner, "Anesthesia", will be in charge of the randomization and the realization of the anesthesia by one of the two techniques (EZ-Block or conventional freehand technique). Another practitioner, "Surgery", will be blinded to the anesthesia technique used. It is this practitioner who will perform the surgical procedure described below.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, 18 years of age or older
- •Dental panoramic radiograph or cone beam examination less than 6 months prior to inclusion
- •Clinical criteria and similar radiographs of the 2 mandibular third molars:
- •Stage of root planing
- •Normoposition, horizontal
- •Type of eruption: disincluded, impacted, impacted
- •Anatomical relationship between inferior alveolar nerve and mandibular wisdom tooth apices similar for both sides
- •Affiliation to a social security scheme
- •Informed consent, dated and signed before any study procedure is performed
排除标准
- •Pregnant or breastfeeding woman
- •Known allergy to the anesthetic molecule or to a component of the anesthetic carpule
- •Contraindication to the use of vasoconstrictor in dental anesthesia
- •Contraindication to a therapeutic procedure under local anesthesia
- •Patients taking TKA for another medical reason
- •Presence of a cystic pathology related to at least 1 of the 2 mandibular third molars to be extracted
- •Limitation of mouth opening
- •Associated systemic pathology requiring priority management
- •Inability of the patient to comply with study follow-up and scheduled visits (especially for second wisdom tooth avulsion)
- •Patient under legal protection
结局指标
主要结局
The success of the truncal infiltration of anesthetic product will be defined as the absence of recourse to additional anesthesia during the procedure
时间窗: During the procedure
The success of the truncal infiltration of anesthetic product will be defined as the absence of recourse to additional anesthesia during the procedure (binary criterion yes / no).
次要结局
- Visual Analog Scale (VAS) of pain(During the procedure)
- Total cumulative dose of anesthetic used(During the procedure)
- Adverse event report(Up to 10 days after the second intervention)