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

NCT ID: NCT05214664

Last Updated: 2023-10-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-08
• Study Completion Date: 2024-12-31

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.

Conditions

Tooth Avulsion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Guiding device for inferior alveolar nerve block

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.

Group Type: EXPERIMENTAL

Anesthesia

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Anesthesia

Intervention Type: 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.

Interventions

Anesthesia

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Elsan

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marie-Alix Fauroux, MD

Role: STUDY_DIRECTOR

CHU Montpellier - UFR Odontologie de Montpellier

Locations

CHU Montpellier

Montpellier, , France

Site Status: RECRUITING

CHRU Nancy Service d'odontologie Brabois adultes

Nancy, , France

Site Status: NOT_YET_RECRUITING

Service de médecine bucco-dentaire Hôpital BRetonneau - APHP

Paris, , France

Site Status: NOT_YET_RECRUITING

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

Strasbourg, , France

Site Status: NOT_YET_RECRUITING

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

Toulouse, , France

Site Status: NOT_YET_RECRUITING

Countries

France

Central Contacts

Nicolas Cailleux, MD

Role: CONTACT

nicolas.caillieux@outlook.com

06 21 87 52 92 ext. +33

Facility Contacts

Marie-Alix Fauroux, MD

Role: primary

ma-fauroux@chu-montpellier.fr

04 67 33 67 48 ext. +33

Julie Guillet, MD

Role: primary

Anne-Laure Ejeil, MD

Role: primary

Fabien Bornert, MD

Role: primary

Sarah Cousty, MD

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 21881056 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30344402 (View on PubMed)

Related Links

https://pubmed.ncbi.nlm.nih.gov/21881056/

Alternative mandibular nerve block techniques: a review of the Gow-Gates and Akinosi-Vazirani closed-mouth mandibular nerve block techniques

https://pubmed.ncbi.nlm.nih.gov/30344402/

Comparison of Efficacy of Halstead, Vazirani Akinosi and Gow Gates Techniques for Mandibular Anesthesia

Other Identifiers

2020-A02755-34

Identifier Type: OTHER

Identifier Source: secondary_id

EZ-BLOCK

Identifier Type: -

Identifier Source: org_study_id