Clinical trial NCT03802305: Comparison of Osteocentral Versus Locoregional Anesthesia in Case of Mandibular Molar Pulpitis
Official title: Comparison of the Variations of the Cardiovascular Parameters and the Efficiency of the Osteocentral Anesthesia (Quicksleeper™) and the Locoregional Anesthesia in the Case of Mandibular Pulpitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endodontic Inflammation
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2019-01-14
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Number of Arms: 2 Masking: Simple Blinded, Masked Roles: Subject Allocation: Randomized Study Endpoint Classification: Interventional Research with Minimal Risk and Constraints, Safety/Efficacy Enrollment: subjects (anticipated)
Primary purpose: TREATMENT

Brief summary: The irreversible acute pulpitis is the most common emergency at the hospital during dental consultation. Pulpitis are characterized by intense and spontaneous oro-facial pains. In case of mandibular molar, the emergency treatment consists in realizing a pulpotomy (eviction of cameral pulp) under locoregional anesthesia called inferior alveolar nerve block (IANB). The latter represents a real challenge, since inflammation may decrease its action. To mitigate this deficiency and the drawbacks of the IANB (onset and duration of the anesthesia, bites risk reported with IANB) other anesthesias are proposed. In particular the computerized intraosseous technique anesthesia of which the Quicksleeper™ system is a part. However, according to the observers, a mild to severe tachycardia have been reported.

Very few valid clinical trials exists on the subject, most being realized with systems of intraosseous anesthesia other than Quicksleeper™. Therefore, the aim of this study is first to analyze the variations of the cardiovascular parameters into two groups of anesthesia: locoregional anesthesia and Quicksleeper ™ system; and then, to compare the efficiency, side effects, operating consequences of both techniques. This study should provide better data about potential risk with computerized intraosseous technique such has Quicksleeper ™ system in healthy or cardiovascular risk patient.

Detailed description: When the patient arrive in the dental care center, an initial assessment is made to get the diagnosis of irreversible pulpitis:

1. Anamnesis:

   acute and spontaneous oro-facial pain, pulsatile severe intensity, which could irradiate toward the ear and/or jaw, exacerbated by cold or hot.
2. Clinical exams: positive vitality tests (electric test and cold pressor test)
3. Further examination (radiography)

The inclusion and exclusion criteria will be checked and the informed consent of the patient will be taken. The patient is then randomized in one of the group (experimental or control). He will fill a questionnaire (Corah's scale) for evaluating his state of anxiety during care. A monitoring of cardiac parameters is made during the care at defined moment.

The patient evaluates his pain himself with the VAS (Visual Analog Score), before the intervention. The anesthesia is carried out by only one experimenter, with the Quickslepper™ handpiece but different specific needles.

Each patient receive 1.8 mL of 4% articaine 1:100 000 on a period of 2 minutes.

Eligibility criteria: Inclusion Criteria:

* real irreversible pulpitis of a mandibular molar in dental emergency consultation at the Nantes hospital
* Healthy patient without medical history (ASA 1), without treatment for heart rate distress (anti arrhythmic, beta-blocking drug)
* Major and covered by the social security
* Informed consent

Exclusion Criteria:

* ASA \> 1
* Pregnant and breastfeeding women
* Minors
* Adults under guardianships
* Adults deprived of freedom
* Impossibility to obtain for informed consent
* Allergy to anesthetic components
* Contraindication of vasoconstrictor
* Angle closure glaucoma

  * Pheochromocytomas
  * Bisphosphonate IV
  * Irradiated patient (upper respiratory and gastrointestinal tract cancer)
  * Contraindication with Mono-amino oxidase inhibitors
* Acute apical periodontitis
* Pulpitis on wisdom teeth
* Vital teeth with fixed prosthesis
* Active periodontal disease
* Local anatomic difficulty
* No reference tooth for vitality dental test

Primary outcomes:
measure: time required (in minutes) to re-obtain the baseline cardiovascular parameters like reported before injection: expected event.
timeFrame: at day 0, from T0 minute to T14 minutes
Secondary outcomes:
measure: Compare the pain of the patient between the two anesthetic techniques
timeFrame: 3 days
measure: Compare the possible postoperative course between the 2 anesthetic techniques
timeFrame: 3 days
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes Universitary Hospital
state: Loire-Atlantique
Study officials:
References: