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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01177423
Other study ID # 2009-08
Secondary ID 2009-A00684-53
Status Completed
Phase N/A
First received October 15, 2009
Last updated August 28, 2014
Start date October 2009
Est. completion date September 2013

Study information

Verified date August 2014
Source Assistance Publique Hopitaux De Marseille
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France Assistance Publique - Hôpitaux de Marseille Marseille

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary To evaluate the Quicksleeper efficiency used in first intention versus inferior alveolar nerve block used in most current dental treatment. 2 years Yes
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