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

NCT03802305 | Completed

• 1 other identifier: RC18_0268
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Endodontic Inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Compare the pain of the patient between the two anesthetic techniques

  3 days

• Compare the possible postoperative course between the 2 anesthetic techniques

  3 days

Study Arms (2)

Computerized intraosseous technique (Quicksleeper™)

EXPERIMENTAL

patients will receive the anesthetic solution with computerized intraosseous technique anesthesia near the tooth roots involved.

Device: computerized intraosseous technique (Quicksleeper™)

loco-regional anesthesia (IANB technique)

ACTIVE COMPARATOR

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)

Interventions

computerized intraosseous technique (Quicksleeper™) DEVICE

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.

Computerized intraosseous technique (Quicksleeper™)

loco-regional anesthesia (IANB technique) DEVICE

The anesthetic solution is delivered by a needle near to the inferior alveolar nerve before it enters the mandibular foramen.

loco-regional anesthesia (IANB technique)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes Universitary Hospital

Nantes, Loire-Atlantique, 44093, France

Location

Related Publications (2)

• Gaudin A, Clouet R, Boeffard C, Laham A, Martin H, Amador Del Valle G, Enkel B, Prud'homme T. Comparing intraosseous computerized anaesthesia with inferior alveolar nerve block in the treatment of symptomatic irreversible pulpitis: A randomized controlled trial. Int Endod J. 2023 Aug;56(8):922-931. doi: 10.1111/iej.13935. Epub 2023 May 29.

  PMID: 37209243 DERIVED

• Laham A, Clouet R, Del Valle GA, Gaudin A, Prud'homme T. Anaesthetic efficacy and influence on cardiovascular parameters change of intraosseous computerised anaesthesia versus inferior alveolar nerve block anaesthesia in acute irreversible pulpitis of mandibular molars: study protocol for a prospective randomised controlled trial. Trials. 2022 Dec 5;23(1):979. doi: 10.1186/s13063-022-06915-4.

  PMID: 36471427 DERIVED

MeSH Terms

Conditions

Pulpitis

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: January 14, 2019
• Study Start: March 1, 2019
• Primary Completion: June 17, 2022
• Study Completion: June 17, 2022
• Last Updated: June 28, 2022

Record last verified: 2022-06

Locations

FR (1)