NCT01177423

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2009

Completed
10 months until next milestone

First Posted

Study publicly available on registry

August 9, 2010

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

August 29, 2014

Status Verified

August 1, 2014

Enrollment Period

3.9 years

First QC Date

October 15, 2009

Last Update Submit

August 28, 2014

Conditions

Dental Pain

Keywords

restorative odontologyPatients cared in restorative odontology department

Outcome Measures

Primary Outcomes (1)

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

    2 years

Study Arms (2)

Quicksleeper intraosseous anesthesia

ACTIVE COMPARATOR

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

Procedure: Dental anesthesia

Inferior alveolar nerve block

ACTIVE COMPARATOR

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

Procedure: Dental anesthesia

Interventions

Dental anesthesiaPROCEDURE

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

Inferior alveolar nerve blockQuicksleeper intraosseous anesthesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique - Hôpitaux de Marseille

Marseille, France

Location

MeSH Terms

Conditions

Toothache

Interventions

Anesthesia, Dental

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesFacial PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and AnalgesiaDentistry

Study Officials

  • Herve TASSERY

    Assistance Publique-Hôpitaux de Marseille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2009

First Posted

August 9, 2010

Study Start

October 1, 2009

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

August 29, 2014

Record last verified: 2014-08

Locations

FR(1)