NCT02012257

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2012

Status
completed

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

September 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 16, 2013

Completed
Last Updated

December 16, 2013

Status Verified

December 1, 2013

Enrollment Period

11 months

First QC Date

December 8, 2013

Last Update Submit

December 10, 2013

Conditions

Keywords

anterior middle superior alveolar nerveelectric pulp testerlocal anesthesia

Outcome Measures

Primary Outcomes (1)

  • 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.

    After each injection (base line) to 60 minutes

Study Arms (3)

Anterior Site

EXPERIMENTAL

AMSA nerve block injection

Procedure: AMSA nerve block injectio

Common Site

EXPERIMENTAL

AMSA nerve block injection

Procedure: AMSA nerve block injectio

Posterior Site

EXPERIMENTAL

AMSA nerve block injection

Procedure: AMSA nerve block injectio

Interventions

Sites of injection

Anterior SiteCommon SitePosterior Site

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Use medications alleviating or altering the pain sensation
  • Allergy to anesthetics Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Masoud Yaghmaei, DMD, MS

    Shahid Beheshti University of Medical Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ali Shokraneh

Study Record Dates

First Submitted

December 8, 2013

First Posted

December 16, 2013

Study Start

September 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

December 16, 2013

Record last verified: 2013-12