NCT03802305

Comparison of Osteocentral Versus Locoregional Anesthesia in Case of Mandibular Molar Pulpitis

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endodontic Inflammation

Interventions

Type	Name	Description
DEVICE	computerized intraosseous technique (Quicksleeper™)	The anesthetic solution is administered with a specific equipment allowing the injection step by step: * anesthesia of the interdental papilla, * positioning of the needle and perforating of the interdental space, * Injection of the solution. All of these steps are based on an adjustment of the different part of this equipment.
DEVICE	loco-regional anesthesia (IANB technique)	The anesthetic solution is delivered by a needle near to the inferior alveolar nerve before it enters the mandibular foramen.

Timeline

• Start date: 2019-03-01
• Primary completion: 2022-06-17
• Completion: 2022-06-17
• First posted: 2019-01-14
• Last updated: 2022-06-28

Locations

1 site across 1 country: France