Efficiency Evaluation of Intradiploic Intra-osseus Anesthesia Versus Inferior Alveolar Nerve Block
Primary Purpose
Dental Pain
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Dental anesthesia
Sponsored by
About this trial
This is an interventional supportive care trial for Dental Pain focused on measuring restorative odontology, Patients cared in restorative odontology department
Eligibility 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
Sites / Locations
- Assistance Publique - Hôpitaux de Marseille
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Quicksleeper intraosseous anesthesia
Inferior alveolar nerve block
Arm Description
Pulpal and periapical molar and premolar sedation is managed by Quicksleeper intraosseous anesthesia.
Pulpal and periapical molar and premolar sedation is managed by inferior alveolar nerve block.
Outcomes
Primary Outcome Measures
To evaluate the Quicksleeper efficiency used in first intention versus inferior alveolar nerve block used in most current dental treatment.
Secondary Outcome Measures
Full Information
NCT ID
NCT01177423
First Posted
October 15, 2009
Last Updated
August 28, 2014
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT01177423
Brief Title
Efficiency Evaluation of Intradiploic Intra-osseus Anesthesia Versus Inferior Alveolar Nerve Block
Official Title
Efficiency Evaluation of Intradiploic Intra-osseus Anesthesia Versus Inferior Alveolar Nerve Block
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Pain
Keywords
restorative odontology, Patients cared in restorative odontology department
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Quicksleeper intraosseous anesthesia
Arm Type
Active Comparator
Arm Description
Pulpal and periapical molar and premolar sedation is managed by Quicksleeper intraosseous anesthesia.
Arm Title
Inferior alveolar nerve block
Arm Type
Active Comparator
Arm Description
Pulpal and periapical molar and premolar sedation is managed by inferior alveolar nerve block.
Intervention Type
Procedure
Intervention Name(s)
Dental anesthesia
Intervention Description
Pulpal and periapical molar and premolar sedation is randomly managed among studied population and Pulp-tester measures anesthesia minute by minute.
Primary Outcome Measure Information:
Title
To evaluate the Quicksleeper efficiency used in first intention versus inferior alveolar nerve block used in most current dental treatment.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herve TASSERY
Organizational Affiliation
Assistance Publique-Hôpitaux de Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique - Hôpitaux de Marseille
City
Marseille
Country
France
12. IPD Sharing Statement
Learn more about this trial
Efficiency Evaluation of Intradiploic Intra-osseus Anesthesia Versus Inferior Alveolar Nerve Block
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