NCT05214664

Efficiency of a Guiding Device for Inferior Alveolar Nerve Block, EZ-Block®, Compared to a Conventional Freehand Administration.

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Elsan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Tooth Avulsion

Interventions

Type	Name	Description
PROCEDURE	Anesthesia	Once the anesthesia is performed by the "Anesthesia" practitioner either with the EZ-Block® device or by the conventional freehand technique, the surgical procedure will be performed in the same way in both arms, and for each tooth, by the "Surgery" practitioner: * The "Surgery" practitioner takes charge of the patient after a post-anesthesia time of 10 minutes and performs a new antisepsis then completes the anesthesia by anesthetizing the buccal and lingual nerve with a carpule of 1.8ml of articaine + adrenaline at 1/200000. * The "Surgery" practitioner starts the surgical procedure. * In the absence of pain, the practitioner "Surgery" carries out the surgical act in its totality (situation of success for the principal criterion of the study) then records the EVA at the end of the intervention.

Timeline

• Start date: 2023-09-08
• Primary completion: 2024-09-01
• Completion: 2024-12-01
• First posted: 2022-01-31
• Last updated: 2023-10-02

Locations

5 sites across 1 country: France