Inferior Alveolar Nerve Block FailurePhase 4NCT01546090
Effect of Alprazolam on the Success of Inferior Alveolar Nerve (IAN) Block
A Phase 4 study testing Alprazolam in people with Inferior Alveolar Nerve Block Failure, run by Isfahan University of Medical Sciences at 2 sites in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inferior Alveolar Nerve Block Failure
- What is being tested?
- Alprazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesIran
- Study dates
- Mar 2011to Feb 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Iran2 sites
School of Dentistry, Isfahan University of Medical Sciences
Isfahan, Isfahan, 8174673461
School of Dentistry, Isfahan University of Medical Sciences
Isfahan, Isfahan, 81747673461
About this study
Official title: Effect of Preoperative Alprazolam on the Success of Inferior Alveolar Nerve Block for Teeth With Irreversible Pulpitis
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.
Read the 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.
- Conditions
- Inferior Alveolar Nerve Block Failure
- Being tested
- Alprazolam, placebo
- Keywords
- Alprazolam, benzodiazepines, Inferior alveolar nerve block, irreversible pulpitis, local anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlprazolamDrug
Also called xanax, Pfizer
preoperative administration of an orally 0.50 mg single dose
placeboDrug
Also called starch
placebo capsules were filled with starch
| Study group | Role | What they receive |
|---|---|---|
| alprazolam | Experimental | Alprazolam is a short-acting anxiolytic of the benzodiazepine class of psychoactive drugs Receives: Drug: Alprazolam |
| placebo | Placebo comparator | placebo capsules were filled with starch Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the success rate of the IAN block
Measured: one hour after administration of alprazolam
Secondary outcomes (1)
initial pain
Measured: one hour after administration of alprazolam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startMar 2011
- Primary completionOct 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inferior Alveolar Nerve Block FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Isfahan
- Responsible party
- Principal investigator, Masoud Saatchi, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01546090
- Sponsor's protocol ID
- 390553
- Other IDs
- 390553, 390553
- Status last verified
- Mar 2012
- First submitted
- 2 Mar 2012
- Last updated
- 7 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18793913
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Alprazolam on the Success of Inferior Alveolar Nerve Block for Teeth With Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT01546090
- Acronym / sponsor ID
- 390553
- Conditions
- Inferior Alveolar Nerve Block Failure
- Keywords
- Alprazolam, benzodiazepines, Inferior alveolar nerve block, irreversible pulpitis, local anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Collaborators
- University of Isfahan
- Study start
- Mar 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 7 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| alprazolam | Experimental | Drug: AlprazolamAlprazolam is a short-acting anxiolytic of the benzodiazepine class of psychoactive drugs |
| placebo | Placebo comparator | Drug: placeboplacebo capsules were filled with starch |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlprazolamAlso: xanax, Pfizerpreoperative administration of an orally 0.50 mg single dose | Drug | alprazolam |
| placeboAlso: starchplacebo capsules were filled with starch | Drug | placebo |
Primary outcome
the success rate of the IAN block
Time frame: one hour after administration of alprazolam
1 secondary outcome
initial pain
Time frame: one hour after administration of alprazolam
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2012.
- Results publication: PubMed 18793913Lindemann 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.
Related trials for Inferior Alveolar Nerve Block Failure
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Intraligamentary vs Inferior Alveolar Nerve Block for Pulpitis: A Randomized Clinical Trial
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Active, not recruitingObservational study
Evaluation of Systemic Inflammatory Index and Biomarkers in Relation to Inferior Alveolar Nerve Block Success and Postoperative Pain
Postoperative Pain, Inferior Alveolar Nerve Block Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alprazolam in people with Inferior Alveolar Nerve Block Failure, run by Isfahan University of Medical Sciences at 2 sites in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the success rate of the IAN block (time frame: one hour after administration of alprazolam). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01546090, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2012.