Tooth Avulsion
Conditions
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.
Interventions
PROCEDUREAnesthesia
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.
Sponsors
Elsan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Masking description
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.
Intervention model description
Multicenter, randomized, single-blind, controlled clinical trial with cross-over.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The success of the truncal infiltration of anesthetic product will be defined as the absence of recourse to additional anesthesia during the procedure | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) of pain | During the procedure | Visual Analog Scale (VAS) of pain |
| Total cumulative dose of anesthetic used | During the procedure | Total cumulative dose of anesthetic used |
| Adverse event report | Up to 10 days after the second intervention | adverse event report |
Other
| Measure | Time frame | Description |
|---|---|---|
| The success of the truncal infiltration of anesthetic product will be compared by center | During the procedure | The success rate of the truncal infiltration of anesthetic product will be compared by center |
Countries
France
Contacts
Primary ContactNicolas Cailleux, MD
Outcome results
None listed