Effect of Alprazolam on the Success of Inferior Alveolar Nerve (IAN) Block
Effect of Preoperative Alprazolam on the Success of Inferior Alveolar Nerve Block for Teeth With Irreversible Pulpitis
1 other identifier
interventional
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2011
Shorter than P25 for phase_4
2 active sites
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
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 2, 2012
CompletedFirst Posted
Study publicly available on registry
March 7, 2012
CompletedMarch 7, 2012
March 1, 2012
7 months
March 2, 2012
March 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the success rate of the IAN block
one hour after administration of alprazolam
Secondary Outcomes (1)
initial pain
one hour after administration of alprazolam
Study Arms (2)
alprazolam
EXPERIMENTALAlprazolam is a short-acting anxiolytic of the benzodiazepine class of psychoactive drugs
placebo
PLACEBO COMPARATORplacebo capsules were filled with starch
Interventions
preoperative administration of an orally 0.50 mg single dose
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Isfahan University of Medical Scienceslead
- University of Isfahancollaborator
Study Sites (2)
School of Dentistry, Isfahan University of Medical Sciences
Isfahan, Isfahan, 8174673461, Iran
School of Dentistry, Isfahan University of Medical Sciences
Isfahan, Isfahan, 81747673461, Iran
Related Publications (1)
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.
PMID: 18793913RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Endodontics
Study Record Dates
First Submitted
March 2, 2012
First Posted
March 7, 2012
Study Start
March 1, 2011
Primary Completion
October 1, 2011
Study Completion
February 1, 2012
Last Updated
March 7, 2012
Record last verified: 2012-03