Back to resultsEffect of Alprazolam on the Success of Inferior Alveolar Nerve (IAN) Block
Primary Purpose
Inferior Alveolar Nerve Block Failure
Status
Completed
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Alprazolam
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Inferior Alveolar Nerve Block Failure focused on measuring Alprazolam, benzodiazepines, Inferior alveolar nerve block, irreversible pulpitis, local anesthesia
Eligibility Criteria
Inclusion Criteria:
- patients with active pain in a mandibular molar
- prolonged response to cold testing with Endo-Frost cold spray
- Absence of any periapical radiolucency on radiographs
- a vital pulp while access cavity preparation
- ability to understand the use of pain scales.
Exclusion Criteria:
- patients were having allergy and sensitivity to benzodiazepines
- pregnant and breast feeding patients
- patients who had taken sedation within 24 hours before the treatment
- having pain in more than one mandibular tooth
- unable to give informed consent
Sites / Locations
- School of Dentistry, Isfahan University of Medical Sciences
- School of Dentistry, Isfahan University of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
alprazolam
placebo
Arm Description
Alprazolam is a short-acting anxiolytic of the benzodiazepine class of psychoactive drugs
placebo capsules were filled with starch
Outcomes
Primary Outcome Measures
the success rate of the IAN block
Secondary Outcome Measures
initial pain
Full Information
NCT ID
NCT01546090
First Posted
March 2, 2012
Last Updated
March 6, 2012
Sponsor
Isfahan University of Medical Sciences
Collaborators
University of Isfahan
1. Study Identification
Unique Protocol Identification Number
NCT01546090
Brief Title
Effect of Alprazolam on the Success of Inferior Alveolar Nerve (IAN) Block
Official Title
Effect of Preoperative Alprazolam on the Success of Inferior Alveolar Nerve Block for Teeth With Irreversible Pulpitis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences
Collaborators
University of Isfahan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this prospective, randomized, double-blind, placebo-controlled study is to evaluate the effect of preoperative administration of alprazolam on the success of the IAN block for teeth with irreversible pulpitis.
Detailed Description
Sixty patients diagnosed with irreversible pulpitis of a mandibular molar randomly receive, in a double-blind manner, identical capsules of either 0.50 mg alprazolam or placebo 45 minutes before the administration of a conventional IAN block. Access is begun 15 minutes after completion of the IAN block, and all patients profound lip numbness. Success is defined as no or mild pain based on visual analog scale recordings during access preparation and initial instrumentation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inferior Alveolar Nerve Block Failure
Keywords
Alprazolam, benzodiazepines, Inferior alveolar nerve block, irreversible pulpitis, local anesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
alprazolam
Arm Type
Experimental
Arm Description
Alprazolam is a short-acting anxiolytic of the benzodiazepine class of psychoactive drugs
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo capsules were filled with starch
Intervention Type
Drug
Intervention Name(s)
Alprazolam
Other Intervention Name(s)
xanax, Pfizer
Intervention Description
preoperative administration of an orally 0.50 mg single dose
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
starch
Intervention Description
placebo capsules were filled with starch
Primary Outcome Measure Information:
Title
the success rate of the IAN block
Time Frame
one hour after administration of alprazolam
Secondary Outcome Measure Information:
Title
initial pain
Time Frame
one hour after administration of alprazolam
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients with active pain in a mandibular molar
prolonged response to cold testing with Endo-Frost cold spray
Absence of any periapical radiolucency on radiographs
a vital pulp while access cavity preparation
ability to understand the use of pain scales.
Exclusion Criteria:
patients were having allergy and sensitivity to benzodiazepines
pregnant and breast feeding patients
patients who had taken sedation within 24 hours before the treatment
having pain in more than one mandibular tooth
unable to give informed consent
Facility Information:
Facility Name
School of Dentistry, Isfahan University of Medical Sciences
City
Isfahan
ZIP/Postal Code
8174673461
Country
Iran, Islamic Republic of
Facility Name
School of Dentistry, Isfahan University of Medical Sciences
City
Isfahan
ZIP/Postal Code
81747673461
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
18793913
Citation
Lindemann M, Reader A, Nusstein J, Drum M, Beck M. Effect of sublingual triazolam on the success of inferior alveolar nerve block in patients with irreversible pulpitis. J Endod. 2008 Oct;34(10):1167-70. doi: 10.1016/j.joen.2008.07.013. Epub 2008 Aug 23.
Results Reference
result
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Effect of Alprazolam on the Success of Inferior Alveolar Nerve (IAN) Block
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