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

Not Applicable

Completed

• Conditions: Dental Pain
• Interventions: Procedure: Dental anesthesia

• Registration Number: NCT01177423
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-15
• Study First Submitted QC: 2010-08-06
• Study First Posted: 2010-08-09
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-28
• Last Update Posted: 2014-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inferior alveolar nerve block	Dental anesthesia	Pulpal and periapical molar and premolar sedation is managed by inferior alveolar nerve block.
Quicksleeper intraosseous anesthesia	Dental anesthesia	Pulpal and periapical molar and premolar sedation is managed by Quicksleeper intraosseous anesthesia.

Primary Outcome Measures

Name	Time	Method
To evaluate the Quicksleeper efficiency used in first intention versus inferior alveolar nerve block used in most current dental treatment.	2 years

Trial Locations

Locations (1)

Assistance Publique - Hôpitaux de Marseille; 🇫🇷 Marseille, France