- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01177423
Efficiency Evaluation of Intradiploic Intra-osseus Anesthesia Versus Inferior Alveolar Nerve Block
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.
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Marseille, France
- Assistance Publique - Hopitaux de Marseille
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Quicksleeper intraosseous anesthesia
Pulpal and periapical molar and premolar sedation is managed by Quicksleeper intraosseous 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.
|
Pulpal and periapical molar and premolar sedation is randomly managed among studied population and Pulp-tester measures anesthesia minute by minute.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the Quicksleeper efficiency used in first intention versus inferior alveolar nerve block used in most current dental treatment.
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Herve TASSERY, Assistance Publique-Hôpitaux de Marseille
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009-08
- 2009-A00684-53
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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