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

Elsan

Status: Enrolling

Conditions: Tooth Avulsion

Treatments: Procedure: Anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT05214664

EZ-BLOCK

2020-A02755-34 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male or female, 18 years of age or older

2. Dental panoramic radiograph or cone beam examination less than 6 months prior to inclusion

3. Clinical criteria and similar radiographs of the 2 mandibular third molars:

   1. Stage of root planing
   2. Normoposition, horizontal
   3. Type of eruption: disincluded, impacted, impacted
   4. Anatomical relationship between inferior alveolar nerve and mandibular wisdom tooth apices similar for both sides

4. Affiliation to a social security scheme

5. Informed consent, dated and signed before any study procedure is performed

Exclusion criteria

1. Pregnant or breastfeeding woman
2. Known allergy to the anesthetic molecule or to a component of the anesthetic carpule
3. Contraindication to the use of vasoconstrictor in dental anesthesia
4. Contraindication to a therapeutic procedure under local anesthesia
5. Patients taking TKA for another medical reason
6. Presence of a cystic pathology related to at least 1 of the 2 mandibular third molars to be extracted
7. Limitation of mouth opening
8. Associated systemic pathology requiring priority management
9. Inability of the patient to comply with study follow-up and scheduled visits (especially for second wisdom tooth avulsion)
10. Patient under legal protection

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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210 participants in 2 patient groups

Guiding device for inferior alveolar nerve block

Experimental group

Description:

The system consists of a reusable angulator with a tube, a reusable plunger, and a single-use syringe body. These three components are combined with a single-use needle and an anesthetic cartridge to create the ready-to-use EZ-Block® device.

Treatment:

Procedure: Anesthesia

Conventional freehand technique for providing anesthesia

Active Comparator group

Description:

The injection site is located in the middle of the triangle with an upper base formed, during maximum mouth opening, outside by the mandibular ramus, inside by the mesial pterygoid muscle and above by the lateral pterygoid muscle. The needle is inserted up to the bone contact (about 20mm) while the body of the syringe is directed towards the contralateral premolars or molars. Use of a disposable carpule syringe with aspiration. Use of a 35mm long needle with a 0.5mm diameter. Use of an articaine anesthesia carpule with adrenaline 1/200000.

Treatment:

Procedure: Anesthesia