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

Last updated: September 29, 2023
Sponsor: Elsan
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Anesthesia

Clinical Study ID

NCT05214664
EZ-BLOCK
2020-A02755-34
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 toinclusion
  3. Clinical criteria and similar radiographs of the 2 mandibular third molars:
  4. Stage of root planing
  5. Normoposition, horizontal
  6. Type of eruption: disincluded, impacted, impacted
  7. Anatomical relationship between inferior alveolar nerve and mandibular wisdomtooth apices similar for both sides
  8. Affiliation to a social security scheme
  9. Informed consent, dated and signed before any study procedure is performed

Exclusion

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 molarsto 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

Study Design

Total Participants: 210
Treatment Group(s): 1
Primary Treatment: Anesthesia
Phase:
Study Start date:
September 08, 2023
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • CHU Montpellier

    Montpellier, 34295
    France

    Active - Recruiting

  • CHRU Nancy Service d'odontologie Brabois adultes

    Nancy, 54500
    France

    Site Not Available

  • Service de médecine bucco-dentaire Hôpital BRetonneau - APHP

    Paris, 75018
    France

    Site Not Available

  • Hôpitaux universitaires de Strasbourg Hôpital Civil Pôle de Médecine et chirurgie bucco-dentaires

    Strasbourg, 67091
    France

    Site Not Available

  • Odontologie et traitement dentaire Pôle clinique des voies respiratoires Faculté de chirurgie dentaire

    Toulouse, 31059
    France

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.