Comparison of Osteocentral Versus Locoregional Anesthesia in Case of Mandibular Molar Pulpitis (COQ)

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

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.

Study Overview

• Status: Completed
• Conditions: Endodontic Inflammation
• Intervention / Treatment: Device: computerized intraosseous technique (Quicksleeper™); Device: loco-regional anesthesia (IANB technique)

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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Loire-Atlantique
    • Nantes, Loire-Atlantique, France, 44093
      • Nantes Universitary Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Computerized intraosseous technique (Quicksleeper™); patients will receive the anesthetic solution with computerized intraosseous technique anesthesia near the tooth roots involved.	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.
Active Comparator: loco-regional anesthesia (IANB technique); patients will receive the anesthetic solution with the loco-regional anesthesia technique: near the place where the nerve goes into the jaw, based on osteo muscular markers.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time required (in minutes) to re-obtain the baseline cardiovascular parameters like reported before injection: expected event.	3 successive values of heart rate similar to those registered before injection.; 3 successive values of blood pressure (diastolic and systolic) similar to those registered before injection.	at day 0, from T0 minute to T14 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the pain of the patient between the two anesthetic techniques	Scores measured with Visual Analog Score( Heft-Parker's pain assessment) (minimum score : no pain ; maximal score : maximum pain unimaginable)	3 days
Compare the possible postoperative course between the 2 anesthetic techniques	The postoperative course will be evaluated using a post-operative table to be completed by the patient at Day + 1, Day + 2 and Day + 3. Collection of information by phone call to the patient. The presence or absence of the following item is measured : pain after waking up, swelling, hematoma, seepage, higher tooth sensation, bite, possibility of feeding, mouth opening limitation.	3 days

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): June 17, 2022
• Study Completion (Actual): June 17, 2022

Study Registration Dates

• First Submitted: December 19, 2018
• First Submitted That Met QC Criteria: January 10, 2019
• First Posted (Actual): January 14, 2019

Study Record Updates

• Last Update Posted (Actual): June 28, 2022
• Last Update Submitted That Met QC Criteria: June 27, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Inflammation; Pulpitis; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: RC18_0268

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No