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

September 4, 2015 updated by: Nahid Mohammadzadeh Akhlaghi, Azad University of Medical Sciences

Comparative Efficacy of Gow-Gates and Inferior Alveolar Nerve Block Injection Techniques on Success Rate of Anesthesia in Patients With Symptomatic Irreversible Pulpitis

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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Gow-Gates injection
An injection technique for infra alveolar nerve anesthesia
One group received Gow-Gates technique and the other group received Infra Alveolar Nerve Block technique for their failed first one anesthesia
Active Comparator: Infra alveolar nerve block injection
An injection technique for infra alveolar nerve anesthesia
One group received Gow-Gates technique and the other group received Infra Alveolar Nerve Block technique for their failed first one anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score
Time Frame: 4 Hours
Heft Parker 170 mm Analog Visual Scale
4 Hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nahid Mohammadzadeh Akhlaghi, DDS, MDS, Associate Professor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

September 4, 2015

First Submitted That Met QC Criteria

September 4, 2015

First Posted (Estimate)

September 7, 2015

Study Record Updates

Last Update Posted (Estimate)

September 7, 2015

Last Update Submitted That Met QC Criteria

September 4, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • AZad UMS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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