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

Study Overview
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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.

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

Conditions
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Dental Pain

Intervention / Treatment
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* Procedure: Dental anesthesia


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Quicksleeper intraosseous anesthesia<br>Pulpal and periapical molar and premolar sedation is managed by Quicksleeper intraosseous anesthesia. | Procedure: Dental anesthesia<br>* Pulpal and periapical molar and premolar sedation is randomly managed among studied population and Pulp-tester measures anesthesia minute by minute.<br>|
| Active Comparator: Inferior alveolar nerve block<br>Pulpal and periapical molar and premolar sedation is managed by inferior alveolar nerve block. | Procedure: Dental anesthesia<br>* Pulpal and periapical molar and premolar sedation is randomly managed among studied population and Pulp-tester measures anesthesia minute by minute.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the Quicksleeper efficiency used in first intention versus inferior alveolar nerve block used in most current dental treatment. |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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restorative odontology, Patients cared in restorative odontology department