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

Tooth Avulsion Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05214664
• Other study ID #: EZ-BLOCK
• Secondary ID: 2020-A02755-34
• Status: Recruiting
• Phase: N/A
• Start date: September 8, 2023
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: Elsan
• Contact: Nicolas Cailleux, MD
• Phone: 06 21 87 52 92
• Email: nicolas.caillieux[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tooth Avulsion

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
France	CHU Montpellier	Montpellier
France	CHRU Nancy Service d'odontologie Brabois adultes	Nancy
France	Service de médecine bucco-dentaire Hôpital BRetonneau - APHP	Paris
France	Hôpitaux universitaires de Strasbourg Hôpital Civil Pôle de Médecine et chirurgie bucco-dentaires	Strasbourg
France	Odontologie et traitement dentaire Pôle clinique des voies respiratoires Faculté de chirurgie dentaire	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Elsan

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Secondary	Visual Analog Scale (VAS) of pain	Visual Analog Scale (VAS) of pain	During the procedure
Secondary	Total cumulative dose of anesthetic used	Total cumulative dose of anesthetic used	During the procedure
Secondary	Adverse event report	adverse event report	Up to 10 days after the second intervention

External Links

•   Alternative mandibular nerve block techniques: a review of the Gow-Gates and Akinosi-Vazirani closed-mouth mandibular nerve block techniques
•   Comparison of Efficacy of Halstead, Vazirani Akinosi and Gow Gates Techniques for Mandibular Anesthesia