Clinical trial NCT05214664: Efficiency of a Guiding Device for Inferior Alveolar Nerve Block, EZ-Block®, Compared to a Conventional Freehand Administration.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tooth Avulsion
Lead sponsor: Elsan
Sponsor class: OTHER
First posted: 2022-01-31
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Multicenter, randomized, single-blind, controlled clinical trial with cross-over.
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: The success of the truncal infiltration of anesthetic product will be defined as the absence of recourse to additional anesthesia during the procedure
timeFrame: During the procedure
Secondary outcomes:
measure: Visual Analog Scale (VAS) of pain
timeFrame: During the procedure
measure: Total cumulative dose of anesthetic used
timeFrame: During the procedure
measure: Adverse event report
timeFrame: Up to 10 days after the second intervention
Other outcomes:
measure: The success of the truncal infiltration of anesthetic product will be compared by center
timeFrame: During the procedure
Locations:
city: Montpellier
country: France
facility: CHU Montpellier
city: Nancy
country: France
facility: CHRU Nancy Service d'odontologie Brabois adultes
city: Paris
country: France
facility: Service de médecine bucco-dentaire Hôpital BRetonneau - APHP
city: Strasbourg
country: France
facility: Hôpitaux universitaires de Strasbourg Hôpital Civil Pôle de Médecine et chirurgie bucco-dentaires
city: Toulouse
country: France
facility: Odontologie et traitement dentaire Pôle clinique des voies respiratoires Faculté de chirurgie dentaire
Study officials:
affiliation: CHU Montpellier - UFR Odontologie de Montpellier
name: Marie-Alix Fauroux, MD
role: STUDY_DIRECTOR
References:
citation: Haas DA. Alternative mandibular nerve block techniques: a review of the Gow-Gates and Akinosi-Vazirani closed-mouth mandibular nerve block techniques. J Am Dent Assoc. 2011 Sep;142 Suppl 3:8S-12S. doi: 10.14219/jada.archive.2011.0341.
citation: Ravi Kiran BS, Kashyap VM, Uppada UK, Tiwari P, Mishra A, Sachdeva A. Comparison of Efficacy of Halstead, Vazirani Akinosi and Gow Gates Techniques for Mandibular Anesthesia. J Maxillofac Oral Surg. 2018 Dec;17(4):570-575. doi: 10.1007/s12663-018-1092-5. Epub 2018 Feb 26.