Efficiency Evaluation of Intradiploic Intra-osseus Anesthesia Versus Inferior Alveolar Nerve Block

NCT ID: NCT01177423

Last Updated: 2014-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2013-09-30

Brief Summary

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Management of dental pain emergencies is a challenge for the clinician, particularly when pain is due to endodontic infection.

Tested hypothesis is intradiploic anesthesia is more effective and quicker than inferior alveolar nerve block for mandibular molars anesthesia.

The aim of the study is the evaluation of Quicksleeper efficiency used in first intention versus inferior alveolar nerve block used in most current dental treatment.

Detailed Description

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Management of dental pain emergencies is a challenge for the clinician, particularly when pain is due to endodontic infection. Failure rate of local anesthesia highly increases with irreversible pulpitis or inflamed periradicular tissue.

Tested hypothesis is intradiploic anesthesia is more effective and quicker than inferior alveolar nerve block for mandibular molars anesthesia (from teeth 35 up to 38 and from 45 up to 48).

The primary aim of the study is the evaluation of Quicksleeper efficiency used in first intention versus inferior alveolar nerve block used in most current dental treatment.

Four clinical situations are evaluated : pulpitis; periapical abcess; pulpal hyperemia; asymptomatic decayed tooth.

Evaluated parameters are : speed of sedation, ability of cure, additional anesthesia needed, total of needles and cartridges used, side effects. Time and validation of complete anesthesia is controlled by pulp tester.

Studied population is patients cared in restorative, endodontics department.

Pulpal and periapical molar and premolar sedation is randomly managed by inferior alveolar nerve block or Quicksleeper intraosseous anesthesia, among studied population (divided in 2 groups of 50 patients). Pulp-tester measures anesthesia minute by minute.

The comparison of study results to bibliography, guidelines and advantages for using mechanical Quicksleeper anesthesia system will be discussed.

Conditions

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Dental Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Quicksleeper intraosseous anesthesia

Pulpal and periapical molar and premolar sedation is managed by Quicksleeper intraosseous anesthesia.

Group Type ACTIVE_COMPARATOR

Dental anesthesia

Intervention Type PROCEDURE

Pulpal and periapical molar and premolar sedation is randomly managed among studied population and Pulp-tester measures anesthesia minute by minute.

Inferior alveolar nerve block

Pulpal and periapical molar and premolar sedation is managed by inferior alveolar nerve block.

Group Type ACTIVE_COMPARATOR

Dental anesthesia

Intervention Type PROCEDURE

Pulpal and periapical molar and premolar sedation is randomly managed among studied population and Pulp-tester measures anesthesia minute by minute.

Interventions

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Dental anesthesia

Pulpal and periapical molar and premolar sedation is randomly managed among studied population and Pulp-tester measures anesthesia minute by minute.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Irreversible pulpitis on second mandibular premolar or mandibular molars
* Necessity of pulpotomy or pulpectomy

Exclusion Criteria

* Pregnancy, chest feeding
* Non dental emergency state
* hypersensibility to local anesthesia
* Pheochromocytoma
* Irregularity of cardiac rhythm
* Myocardial infarct in the 6 previous months
* Hepatic porphyria
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Herve TASSERY

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique-Hôpitaux de Marseille

Locations

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Assistance Publique - Hôpitaux de Marseille

Marseille, , France

Site Status

Countries

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France

Other Identifiers

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2009-A00684-53

Identifier Type: -

Identifier Source: secondary_id

2009-08

Identifier Type: -

Identifier Source: org_study_id

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