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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A02755-34 | Other Identifier | ANSM |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) of pain | Visual Analog Scale (VAS) of pain | During the procedure |
| Total cumulative dose of anesthetic used | Total cumulative dose of anesthetic used |
| Measure | Description | Time Frame |
|---|---|---|
| The success of the truncal infiltration of anesthetic product will be compared by center | The success rate of the truncal infiltration of anesthetic product will be compared by center | During the procedure |
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:
Affiliation to a social security scheme
Informed consent, dated and signed before any study procedure is performed
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicolas Cailleux, MD | Contact | 06 21 87 52 92 | +33 | nicolas.caillieux@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| Marie-Alix Fauroux, MD | CHU Montpellier - UFR Odontologie de Montpellier | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Montpellier | Recruiting | Montpellier | 34295 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21881056 | Background | 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. | |
| 30344402 | 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. |
| Label | URL |
|---|---|
| Alternative mandibular nerve block techniques: a review of the Gow-Gates and Akinosi-Vazirani closed-mouth mandibular nerve block techniques | View source |
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| ID | Term |
|---|---|
| D014084 | Tooth Avulsion |
| ID | Term |
|---|---|
| D018677 | Tooth Injuries |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D000758 | Anesthesia |
| ID | Term |
|---|---|
| D000760 | Anesthesia and Analgesia |
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Multicenter, randomized, single-blind, controlled clinical trial with cross-over.
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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.
|
| During the procedure |
| Adverse event report | adverse event report | Up to 10 days after the second intervention |
| CHRU Nancy Service d'odontologie Brabois adultes | Not yet recruiting | Nancy | 54500 | France |
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| Service de médecine bucco-dentaire Hôpital BRetonneau - APHP | Not yet recruiting | Paris | 75018 | France |
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| Hôpitaux universitaires de Strasbourg Hôpital Civil Pôle de Médecine et chirurgie bucco-dentaires | Not yet recruiting | Strasbourg | 67091 | France |
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| Odontologie et traitement dentaire Pôle clinique des voies respiratoires Faculté de chirurgie dentaire | Not yet recruiting | Toulouse | 31059 | France |
|
| Comparison of Efficacy of Halstead, Vazirani Akinosi and Gow Gates Techniques for Mandibular Anesthesia | View source |