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

Primary Purpose

Tooth Avulsion

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Anesthesia
Sponsored by
Elsan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Tooth Avulsion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • CHU MontpellierRecruiting
  • CHRU Nancy Service d'odontologie Brabois adultes
  • Service de médecine bucco-dentaire Hôpital BRetonneau - APHP
  • Hôpitaux universitaires de Strasbourg Hôpital Civil Pôle de Médecine et chirurgie bucco-dentaires
  • Odontologie et traitement dentaire Pôle clinique des voies respiratoires Faculté de chirurgie dentaire

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Guiding device for inferior alveolar nerve block

Conventional freehand technique for providing anesthesia

Arm 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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Visual Analog Scale (VAS) of pain
Visual Analog Scale (VAS) of pain
Total cumulative dose of anesthetic used
Total cumulative dose of anesthetic used
Adverse event report
adverse event report

Full Information

First Posted
January 17, 2022
Last Updated
September 29, 2023
Sponsor
Elsan
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1. Study Identification

Unique Protocol Identification Number
NCT05214664
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 8, 2023 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Elsan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Avulsion

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Multicenter, randomized, single-blind, controlled clinical trial with cross-over.
Masking
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 (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.
Allocation
Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Guiding device for inferior alveolar nerve block
Arm Type
Experimental
Arm 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.
Arm Title
Conventional freehand technique for providing anesthesia
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Anesthesia
Intervention Description
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.
Primary Outcome Measure Information:
Title
The success of the truncal infiltration of anesthetic product will be defined as the absence of recourse to additional anesthesia during the procedure
Description
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).
Time Frame
During the procedure
Secondary Outcome Measure Information:
Title
Visual Analog Scale (VAS) of pain
Description
Visual Analog Scale (VAS) of pain
Time Frame
During the procedure
Title
Total cumulative dose of anesthetic used
Description
Total cumulative dose of anesthetic used
Time Frame
During the procedure
Title
Adverse event report
Description
adverse event report
Time Frame
Up to 10 days after the second intervention
Other Pre-specified Outcome Measures:
Title
The success of the truncal infiltration of anesthetic product will be compared by center
Description
The success rate of the truncal infiltration of anesthetic product will be compared by center
Time Frame
During the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male or female, 18 years of age or older Dental panoramic radiograph or cone beam examination less than 6 months prior to inclusion 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas Cailleux, MD
Phone
06 21 87 52 92
Ext
+33
Email
nicolas.caillieux@outlook.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Alix Fauroux, MD
Organizational Affiliation
CHU Montpellier - UFR Odontologie de Montpellier
Official's Role
Study Director
Facility Information:
Facility Name
CHU Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Alix Fauroux, MD
Phone
04 67 33 67 48
Ext
+33
Email
ma-fauroux@chu-montpellier.fr
Facility Name
CHRU Nancy Service d'odontologie Brabois adultes
City
Nancy
ZIP/Postal Code
54500
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Guillet, MD
First Name & Middle Initial & Last Name & Degree
Charlène Kichenbrand, MD
Facility Name
Service de médecine bucco-dentaire Hôpital BRetonneau - APHP
City
Paris
ZIP/Postal Code
75018
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne-Laure Ejeil, MD
First Name & Middle Initial & Last Name & Degree
Ludovic Sicard, MD
Facility Name
Hôpitaux universitaires de Strasbourg Hôpital Civil Pôle de Médecine et chirurgie bucco-dentaires
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabien Bornert, MD
First Name & Middle Initial & Last Name & Degree
Chadi Afif, MD
Facility Name
Odontologie et traitement dentaire Pôle clinique des voies respiratoires Faculté de chirurgie dentaire
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Cousty, MD
First Name & Middle Initial & Last Name & Degree
Clément Cambronne, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
21881056
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.
Results Reference
background
PubMed Identifier
30344402
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.
Results Reference
background
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/21881056/
Description
Alternative mandibular nerve block techniques: a review of the Gow-Gates and Akinosi-Vazirani closed-mouth mandibular nerve block techniques
URL
https://pubmed.ncbi.nlm.nih.gov/30344402/
Description
Comparison of Efficacy of Halstead, Vazirani Akinosi and Gow Gates Techniques for Mandibular Anesthesia

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

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