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

June 27, 2022 updated by: Nantes University Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
time required (in minutes) to re-obtain the baseline cardiovascular parameters like reported before injection: expected event.
Time Frame: at day 0, from T0 minute to T14 minutes
  • 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Compare the pain of the patient between the two anesthetic techniques
Time Frame: 3 days
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
Time Frame: 3 days
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 17, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 17, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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