Comparing a new device for dental anesthesia to traditional methods

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.

This study is testing a new dental anesthesia device to see if it works better than the traditional method for numbing patients during tooth surgeries.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 210 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Elsan (Academic / other)
• Locations: 5 sites (Montpellier and 4 other locations)
• Trial ID: NCT05214664 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of the EZ-Block® guidance system for administering inferior alveolar nerve blocks compared to the conventional freehand technique. The research aims to address the high failure rate associated with traditional methods, which can be as high as 40% during procedures like the surgical removal of impacted lower third molars. By utilizing individualized anatomical data, the EZ-Block® system seeks to improve the success rate of anesthesia in dental surgeries. Participants will undergo a comparative analysis to determine which method yields better outcomes in terms of anesthesia effectiveness.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who require surgical removal of impacted lower third molars and meet specific anatomical criteria.

Not a fit: Patients who are pregnant, breastfeeding, or have contraindications to local anesthesia will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more reliable and effective dental anesthesia, reducing pain and anxiety for patients during procedures.

How similar studies have performed: While traditional methods have shown variable success rates, the use of guided systems like EZ-Block® is a novel approach that has not been extensively tested in this specific context.

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

Where this trial is running

Montpellier and 4 other locations

• CHU Montpellier — Montpellier, France (Recruiting)
• CHRU Nancy Service d'odontologie Brabois adultes — Nancy, France (Not_yet_recruiting)
• Service de médecine bucco-dentaire Hôpital BRetonneau - APHP — Paris, France (Not_yet_recruiting)
• Hôpitaux universitaires de Strasbourg Hôpital Civil Pôle de Médecine et chirurgie bucco-dentaires — Strasbourg, France (Not_yet_recruiting)
• Odontologie et traitement dentaire Pôle clinique des voies respiratoires Faculté de chirurgie dentaire — Toulouse, France (Not_yet_recruiting)

Study contacts

• Study coordinator: Nicolas Cailleux, MD

Conditions Tooth Avulsion