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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Assistance Publique Hopitaux De Marseille.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01177423
First received: October 15, 2009
Last updated: August 6, 2010
Last verified: August 2010
  Purpose

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.


Condition Intervention
Dental Pain
Procedure: Dental anesthesia

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Efficiency Evaluation of Intradiploic Intra-osseus Anesthesia Versus Inferior Alveolar Nerve Block

Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • To evaluate the Quicksleeper efficiency used in first intention versus inferior alveolar nerve block used in most current dental treatment. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: October 2009
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Quicksleeper intraosseous anesthesia
Pulpal and periapical molar and premolar sedation is managed by Quicksleeper intraosseous anesthesia.
Procedure: Dental anesthesia
Pulpal and periapical molar and premolar sedation is randomly managed among studied population and Pulp-tester measures anesthesia minute by minute.
Active Comparator: Inferior alveolar nerve block
Pulpal and periapical molar and premolar sedation is managed by inferior alveolar nerve block.
Procedure: Dental anesthesia
Pulpal and periapical molar and premolar sedation is randomly managed among studied population and Pulp-tester measures anesthesia minute by minute.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01177423

Contacts
Contact: Herve Tassery herve.tassery@ap-hm.fr

Locations
France
Assistance Publique - Hôpitaux de Marseille Recruiting
Marseille, France
Contact: Herve TASSERY       herve.tassery@ap-hm.fr   
Principal Investigator: Herve TASSERY         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: Herve TASSERY Assistance Publique-Hôpitaux de Marseille
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Marseille, Direction de la Recherche
ClinicalTrials.gov Identifier: NCT01177423     History of Changes
Other Study ID Numbers: 2009-08, 2009-A00684-53
Study First Received: October 15, 2009
Last Updated: August 6, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Assistance Publique Hopitaux De Marseille:
restorative odontology
Patients cared in restorative odontology department

Additional relevant MeSH terms:
Toothache
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Signs and Symptoms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014