Efficacy of Two Injection Techniques on Success Rate of Inferior Alveolar Nerve Anesthesia

NCT ID: NCT02543619

Last Updated: 2015-09-07

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

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-08-31

Brief Summary

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Forty healthy patients with including criteria who failed to infra alveolar nerve block injection (without lip numbness) have been randomly divided into two groups on a random basis and have received Gow-Gates or another inferior alveolar nerve block injection. Endodontic access cavity preparation has been initiated after complete anesthesia. If patients felt any pain during the steps of caries or dentin removal, Endodontic access cavity preparation or canal working length determination, treatment has been stopped and their pain has been measured by Heft Parker 170 mm Visual Analog Scale (Zero as no pain and 170 as maximum pain ).The data has been analyzed by Mann-U-Whitney and CHI- SQUARE tests.

Detailed Description

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The aim of this study was to assess the efficacy of Gow-Gates and inferior alveolar nerve block on success rate of anesthesia in patients with irreversible pulpitis. In this prospective, randomized, double-blind study , forty healthy patients with symptomatic irreversible pulpitis and including criteria who failed to infra alveolar nerve block injection (without lip numbness) have been randomly divided into two groups on a random basis and have received Gow-Gates or another inferior alveolar nerve block injection. Their pain has been evaluated by electric pulp tester every 5 minutes for two times. Endodontic access cavity preparation has been initiated after complete anesthesia. If patients felt any pain during the steps of caries or dentin removal, Endodontic access cavity preparation or canal working length determination, treatment has been stopped and their pain has been measured by Heft Parker 170 mm Visual Analog Scale (Zero as no pain and 170 as maximum pain ). The patients have been instructed to rate any pain during each of the mentioned steps. The data have been analyzed by Mann-U-Whitney and CHI- SQUARE tests.

Conditions

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Failed Mechanical Induction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Gow-Gates injection

An injection technique for infra alveolar nerve anesthesia

Group Type ACTIVE_COMPARATOR

Injection technique

Intervention Type OTHER

One group received Gow-Gates technique and the other group received Infra Alveolar Nerve Block technique for their failed first one anesthesia

Infra alveolar nerve block injection

An injection technique for infra alveolar nerve anesthesia

Group Type ACTIVE_COMPARATOR

Injection technique

Intervention Type OTHER

One group received Gow-Gates technique and the other group received Infra Alveolar Nerve Block technique for their failed first one anesthesia

Interventions

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Injection technique

One group received Gow-Gates technique and the other group received Infra Alveolar Nerve Block technique for their failed first one anesthesia

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with symptomatic irreversible pulpitis ( Visual Analog Scale ≥ 54) in one mandibular molar who need root canal treatment
* without systemic diseases
* non smoking
* non analgesic/sedative or any medicine consumption
* non pregnant
* non breast feeding
* the patients who received one conventional inferior alveolar nerve block and their block was failed ( without lip numbness)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Azad University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Nahid Mohammadzadeh Akhlaghi

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nahid Mohammadzadeh Akhlaghi, DDS, MDS

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

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Dental Branch, AZad UMS

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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AZad UMS

Identifier Type: -

Identifier Source: org_study_id

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