AzTrials
AzTrials

Tooth AvulsionNCT05214664

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

A study testing Anesthesia in people with Tooth Avulsion, run by Elsan at 5 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Tooth Avulsion
What is being tested?
Anesthesia
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
5 sitesFrance
Study dates
8 Sep 2023to Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

5 sites in 1 country.

Nicolas Cailleux, MD contact

06 21 87 52 92 ext. +33

nicolas.caillieux@outlook.com

5 sites in 1 country

France5 sites, 5 recruiting

  • CHU Montpellier

    Montpellier, 34295

    Marie-Alix Fauroux, MD, 04 67 33 67 48 ext. +33, ma-fauroux@chu-montpellier.fr

    Recruiting

  • CHRU Nancy Service d'odontologie Brabois adultes

    Nancy, 54500

    Julie Guillet, MD

    Charlène Kichenbrand, MD

    Not yet recruiting

  • Service de médecine bucco-dentaire Hôpital BRetonneau - APHP

    Paris, 75018

    Anne-Laure Ejeil, MD

    Ludovic Sicard, MD

    Not yet recruiting

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

    Strasbourg, 67091

    Fabien Bornert, MD

    Chadi Afif, MD

    Not yet recruiting

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

    Toulouse, 31059

    Sarah Cousty, MD

    Clément Cambronne, MD

    Not yet recruiting

Other trials in France

About this study

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.

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.

Read the 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
Being tested
Anesthesia
Medical subject headings
Tooth Avulsion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AnesthesiaProcedure or surgery

    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.
Study groups in NCT05214664
Study groupRoleWhat they receive
Guiding device for inferior alveolar nerve blockExperimentalThe 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.
Receives: Procedure: Anesthesia
Conventional freehand technique for providing anesthesiaActive comparatorThe 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.
Receives: Procedure: Anesthesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: During the procedure

Secondary outcomes (3)

  1. Visual Analog Scale (VAS) of pain

    Visual Analog Scale (VAS) of pain

    Measured: During the procedure

  2. Total cumulative dose of anesthetic used

    Total cumulative dose of anesthetic used

    Measured: During the procedure

  3. Adverse event report

    adverse event report

    Measured: Up to 10 days after the second intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2022
  2. Study start8 Sep 2023
  3. Primary completionSep 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Model description
Multicenter, randomized, single-blind, controlled clinical trial with cross-over.
Masking
Single blind
Who is masked
Investigator
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05214664
Sponsor's protocol ID
EZ-BLOCK
Other IDs
2020-A02755-34
Status last verified
Sep 2023
First submitted
17 Jan 2022
Last updated
2 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 21881056

  • 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.

    PubMed 30344402

Questions about this trial

What is this clinical trial studying?

A study testing Anesthesia in people with Tooth Avulsion, run by Elsan at 5 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nicolas Cailleux, MD (06 21 87 52 92 ext. +33, nicolas.caillieux@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05214664, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in