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Efficiency of a Guiding Device for Mandibular Foramen Anesthesia, EZ-Block®, Compared to a Conventional Technique

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ClinicalTrials.gov Identifier: NCT05214664
Recruitment Status : Not yet recruiting
First Posted : January 31, 2022
Last Update Posted : March 28, 2022
Sponsor:
Information provided by (Responsible Party):
Elsan

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.


Condition or disease Intervention/treatment Phase
Tooth Avulsion Procedure: Anesthesia Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Multicenter, randomized, single-blind, controlled clinical trial with cross-over.
Masking: Single (Investigator)
Masking Description: 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 described in section 2.2 and 2.3 of the protocol. Another practitioner, "Surgery", will be blinded to the anesthesia technique used. It is this practitioner who will perform the surgical procedure described below.
Primary Purpose: Other
Official Title: Efficacy of a Guiding Device for Mandibular Foramen Anesthesia, EZ-Block®, Compared With a Conventional "Freehand" Technique During Mandibular Wisdom Teeth Avulsion.
Estimated Study Start Date : September 1, 2022
Estimated Primary Completion Date : September 15, 2023
Estimated Study Completion Date : October 1, 2023

Arm Intervention/treatment
Experimental: A guidance system for the realization of a truncal anesthesia close to mandibular foramen

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

Once the anesthesia is performed by the "Anesthesia" practitioner either with the EZ-Block® device (as described in section 2.2) or by the conventional freehand technique (as described in section 2.3), 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.

Active Comparator: Conventional locoregional anesthesia is performed using osteomuscular landmarks

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

Once the anesthesia is performed by the "Anesthesia" practitioner either with the EZ-Block® device (as described in section 2.2) or by the conventional freehand technique (as described in section 2.3), 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.




Primary Outcome Measures :
  1. The success of the truncal infiltration of anesthetic product will be defined as the absence of recourse to additional anesthesia during the procedure [ Time Frame: 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).


Secondary Outcome Measures :
  1. Visual Analog Scale (VAS) of pain [ Time Frame: During the procedure ]
    Visual Analog Scale (VAS) of pain

  2. Total cumulative dose of anesthetic used [ Time Frame: During the procedure ]
    Total cumulative dose of anesthetic used

  3. Adverse event report [ Time Frame: Up to 10 days after the second intervention ]
    adverse event report


Other Outcome Measures:
  1. The success of the truncal infiltration of anesthetic product will be compared by center [ Time Frame: During the procedure ]
    The success rate of the truncal infiltration of anesthetic product will be compared by center



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05214664


Contacts
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Contact: Nicolas Cailleux, MD 06 21 87 52 92 ext +33 nicolas.caillieux@outlook.com

Locations
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France
CHU Montpellier
Montpellier, France, 34295
CHRU Nancy Service d'odontologie Brabois adultes
Nancy, France, 54500
Contact: Julie Guillet, MD         
Sub-Investigator: Charlène Kichenbrand, MD         
Service de médecine bucco-dentaire Hôpital BRetonneau - APHP
Paris, France, 75018
Contact: Anne-Laure Ejeil, MD         
Sub-Investigator: Ludovic Sicard, MD         
Hôpitaux universitaires de Strasbourg Hôpital Civil Pôle de Médecine et chirurgie bucco-dentaires
Strasbourg, France, 67091
Contact: Fabien Bornert, MD         
Sub-Investigator: Chadi Afif, MD         
Odontologie et traitement dentaire Pôle clinique des voies respiratoires Faculté de chirurgie de taire
Toulouse, France, 31059
Contact: Sarah Cousty, MD         
Sub-Investigator: Clément Cambronne, MD         
Sponsors and Collaborators
Elsan
Investigators
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Study Director: Marie-Alix Fauroux, MD CHU Montpellier - UFR Odontologie de Montpellier
Additional Information:
Publications:
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Responsible Party: Elsan
ClinicalTrials.gov Identifier: NCT05214664    
Other Study ID Numbers: EZ-BLOCK
2020-A02755-34 ( Other Identifier: ANSM )
First Posted: January 31, 2022    Key Record Dates
Last Update Posted: March 28, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tooth Avulsion
Fractures, Avulsion
Fractures, Bone
Wounds and Injuries
Tooth Injuries
Tooth Diseases
Stomatognathic Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs