Anesthesia; FunctionalNCT02012257
Success Rate of Anterior Middle Superior Alveolar (AMSA) Nerve Block in Three Different Sites of Injection
A study testing AMSA nerve block injectio in people with Anesthesia; Functional, run by Shahid Beheshti University of Medical Sciences.
Trial summary
AMSA nerve block injection is targeted anterior superior alveolar nerve and middle superior alveolar nerve branches of infraorbital nerve through nutrient canals. Therefore, central to second premolar teeth of one quadrant can be anesthetized. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anesthesia; Functional
- What is being tested?
- AMSA nerve block injectio
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Aug 2013
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy subject
- Subjects had all their maxillary teeth from second premolar of one side to the second premolar of another Neither of these teeth was non vital, nor had large restorations, prosthetic crowns, caries, periodontal disease, history of trauma, and hypersensitivity.
Who cannot join
- Use medications alleviating or altering the pain sensation
- Allergy to anesthetics Pregnancy
About this study
AMSA nerve block injection is targeted anterior superior alveolar nerve and middle superior alveolar nerve branches of infraorbital nerve through nutrient canals. Therefore, central to second premolar teeth of one quadrant can be anesthetized. The aim of the present study was to evaluate the efficacy of AMSA nerve block injection at an anterior and a posterior positions compared to commonly administrated site.
Read the detailed description
AMSA: Anterior middle superior alveolar
- Conditions
- Anesthesia; Functional
- Being tested
- AMSA nerve block injectio
- Keywords
- anterior middle superior alveolar nerve, electric pulp tester, local anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMSA nerve block injectioProcedure or surgery
Sites of injection
| Study group | Role | What they receive |
|---|---|---|
| Anterior Site | Experimental | AMSA nerve block injection Receives: Procedure: AMSA nerve block injectio |
| Common Site | Experimental | AMSA nerve block injection Receives: Procedure: AMSA nerve block injectio |
| Posterior Site | Experimental | AMSA nerve block injection Receives: Procedure: AMSA nerve block injectio |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulpal anesthesia of central incisor to second premolar by electric pulp tester (EPT)
Each teeth were evaluated by electric pulp tester immediately after injection to 60 minutes every six minutes. Having no reaction to the EPT was the criterion of considering a tooth has been anaesthetized. Anesthesia was considered successful if no reaction to the maximum output for two consecutive tests.
Measured: After each injection (base line) to 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study startSep 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia; FunctionalStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Shokraneh, DDS, MS, Shahid Beheshti University of Medical Sciences
- Investigators
- Masoud Yaghmaei, DMD, MS, Study chair, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02012257
- Sponsor's protocol ID
- 2952
- Status last verified
- Dec 2013
- First submitted
- 8 Dec 2013
- Last updated
- 16 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Success Rate of Anterior Middle Superior Alveolar (AMSA) Nerve Block in Three Different Sites of Injection
- ClinicalTrials.gov ID
- NCT02012257
- Acronym / sponsor ID
- 2952
- Conditions
- Anesthesia; Functional
- Keywords
- anterior middle superior alveolar nerve, electric pulp tester, local anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 16 Dec 2013 (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.
AMSA nerve block injection is targeted anterior superior alveolar nerve and middle superior alveolar nerve branches of infraorbital nerve through nutrient canals. Therefore, central to second premolar teeth of one quadrant can be anesthetized. The aim of the present study was to evaluate the efficacy of AMSA nerve block injection at an anterior and a posterior positions compared to commonly administrated site.
Detailed description
AMSA: Anterior middle superior alveolar
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anterior Site | Experimental | Procedure: AMSA nerve block injectioAMSA nerve block injection |
| Common Site | Experimental | Procedure: AMSA nerve block injectioAMSA nerve block injection |
| Posterior Site | Experimental | Procedure: AMSA nerve block injectioAMSA nerve block injection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy subject
- Subjects had all their maxillary teeth from second premolar of one side to the second premolar of another Neither of these teeth was non vital, nor had large restorations, prosthetic crowns, caries, periodontal disease, history of trauma, and hypersensitivity.
Key exclusion criteria (2 listed)
- Use medications alleviating or altering the pain sensation
- Allergy to anesthetics Pregnancy
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 |
|---|---|---|
| AMSA nerve block injectioSites of injection | Procedure or surgery | Anterior Site, Common Site, Posterior Site |
Primary outcome
Pulpal anesthesia of central incisor to second premolar by electric pulp tester (EPT)
Time frame: After each injection (base line) to 60 minutes
Each teeth were evaluated by electric pulp tester immediately after injection to 60 minutes every six minutes. Having no reaction to the EPT was the criterion of considering a tooth has been anaesthetized. Anesthesia was considered successful if no reaction to the maximum output for two consecutive tests.
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 16 Dec 2013.
Related trials for Anesthesia; Functional
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Active, not recruitingObservational study
The Effect of Single Lung Ventilation Duration and Intraoperative Brain Oxygenation on Cognitive Function and Postoperative Pain in Geriatric Patients
Thoracic Anesthesia, Geriatric Anesthesia
Not yet recruiting
Impact of High Thoracic Paravertebral Block on Diaphragmatic Function: a Prospective Study
Breast Cancer Surgery, Breast Cancer Surgery Pain
Not yet recruiting
Effect of Opioid-free Anesthesia on Sleep Quality, Cognitive Function and Recovery Quality After General Anesthesia in Elderly Patients
Opioid-Free Anesthesia, POCD
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.
Masoud Yaghmaei, DMD, MS study chair
Shahid Beheshti University of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A study testing AMSA nerve block injectio in people with Anesthesia; Functional, run by Shahid Beheshti University of Medical Sciences.
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 2 inclusion and 2 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 16 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Pulpal anesthesia of central incisor to second premolar by electric pulp tester (EPT) (time frame: After each injection (base line) to 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2013.