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CompletedNCT01177423Updated Aug 29, 2014

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

An interventional study of Dental anesthesia in Dental Pain, sponsored by Assistance Publique Hopitaux De Marseille. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-08-29.

Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Dental Pain

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Keywords

  • restorative odontology
  • Patients cared in restorative odontology department
03

In context

Toothache

140 studies on the registry are indexed under Toothache; 24 are open to participants now.

This study's enrollment of 37 is below the median of 100 across 121 interventional studies indexed under Toothache.

Browse Toothache studies →

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Active comparator
    Quicksleeper intraosseous anesthesia

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

    Procedure: Dental anesthesia

  • Active comparator
    Inferior alveolar nerve block

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

    Procedure: Dental anesthesia

Interventions

  • ProcedureDental anesthesia

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

06

What researchers measure

Primary outcomes

  1. To evaluate the Quicksleeper efficiency used in first intention versus inferior alveolar nerve block used in most current dental treatment.

    Time frame: 2 years

07

Study locations

1 site
  • Assistance Publique - Hôpitaux de Marseille
    Marseille, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01177423
Lead sponsor
Assistance Publique Hopitaux De Marseille
Responsible party
Sponsor
First posted
Aug 9, 2010
Start date
Oct 2009
Primary completion
Sep 2013
Completion
Sep 2013
Last update
Aug 29, 2014

Study contacts

Herve TASSERY
principal investigator · Assistance Publique-Hôpitaux de Marseille

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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