Effect of Alprazolam on the Success of Inferior Alveolar Nerve (IAN) Block

NCT ID: NCT01546090

Last Updated: 2012-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-02-29

Brief Summary

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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

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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.

Conditions

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Inferior Alveolar Nerve Block Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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alprazolam

Alprazolam is a short-acting anxiolytic of the benzodiazepine class of psychoactive drugs

Group Type EXPERIMENTAL

Alprazolam

Intervention Type DRUG

preoperative administration of an orally 0.50 mg single dose

placebo

placebo capsules were filled with starch

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo capsules were filled with starch

Interventions

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Alprazolam

preoperative administration of an orally 0.50 mg single dose

Intervention Type DRUG

placebo

placebo capsules were filled with starch

Intervention Type DRUG

Other Intervention Names

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xanax, Pfizer starch

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Isfahan

OTHER

Sponsor Role collaborator

Isfahan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Masoud Saatchi

Associate Professor of Endodontics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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School of Dentistry, Isfahan University of Medical Sciences

Isfahan, Isfahan, Iran

Site Status

School of Dentistry, Isfahan University of Medical Sciences

Isfahan, Isfahan, Iran

Site Status

Countries

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Iran

References

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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.

Reference Type RESULT
PMID: 18793913 (View on PubMed)

Other Identifiers

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390553

Identifier Type: -

Identifier Source: secondary_id

390553

Identifier Type: OTHER

Identifier Source: secondary_id

390553

Identifier Type: -

Identifier Source: org_study_id

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