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

NCT05214664 | Unknown

• 2 other identifiers: EZ-BLOCK2020-A02755-34
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 5

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.

Conditions

Tooth Avulsion

Outcome Measures

Primary Outcomes (1)

• The success of the truncal infiltration of anesthetic product will be defined as the absence of recourse to additional anesthesia 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).

  During the procedure

Secondary Outcomes (3)

• 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

Other Outcomes (1)

• The success of the truncal infiltration of anesthetic product will be compared by center

  During the procedure

Study Arms (2)

Guiding device for inferior alveolar nerve block

EXPERIMENTAL

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.

Procedure: Anesthesia

Conventional freehand technique for providing anesthesia

ACTIVE COMPARATOR

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.

Procedure: Anesthesia

Interventions

Anesthesia PROCEDURE

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.

Conventional freehand technique for providing anesthesia; Guiding device for inferior alveolar nerve block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18 years of age or older
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Elsan: lead

Study Sites (5)

CHU Montpellier

Montpellier, 34295, France

RECRUITING

CHRU Nancy Service d'odontologie Brabois adultes

Nancy, 54500, France

NOT YET RECRUITING

Service de médecine bucco-dentaire Hôpital BRetonneau - APHP

Paris, 75018, France

NOT YET RECRUITING

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

Strasbourg, 67091, France

NOT YET RECRUITING

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

Toulouse, 31059, France

NOT YET RECRUITING

Related Publications (2)

• 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.

  PMID: 21881056 BACKGROUND

• 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.

  PMID: 30344402 BACKGROUND

Related Links

• Alternative mandibular nerve block techniques: a review of the Gow-Gates and Akinosi-Vazirani closed-mouth mandibular nerve block techniques
• Comparison of Efficacy of Halstead, Vazirani Akinosi and Gow Gates Techniques for Mandibular Anesthesia

MeSH Terms

Conditions

Tooth Avulsion

Interventions

Anesthesia

Condition Hierarchy (Ancestors)

Tooth Injuries; Tooth Diseases; Stomatognathic Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

• Marie-Alix Fauroux, MD

  CHU Montpellier - UFR Odontologie de Montpellier

  STUDY DIRECTOR

Central Study Contacts

Nicolas Cailleux, MD

CONTACT

06 21 87 52 92; nicolas.caillieux@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, randomized, single-blind, controlled clinical trial with cross-over.

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: January 31, 2022
• Study Start: September 8, 2023
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 2, 2023

Record last verified: 2023-09

Locations

FR (5)