Effect of Inferior Alveolar and Gow-Gates Nerve Block Techniques for Symptomatic Mandibular Molars

May 4, 2017 updated by: Masoud Saatchi, DDS MSc, Isfahan University of Medical Sciences
Introduction: to evaluate the efficacy of inferior alveolar nerve block (IANB), Gow-Gates nerve block (GGNB), and their combination in patients with irreversible pulpitis. Methods: One hundred fifty subjects with irreversible pulpitis of a mandibular molar were selected. subjects randomly received two IANB injections or two GGNB injections or their combination of 1.8 mL 2% lidocaine with 1:100,000 epinephrine. Success was specified as no or mild pain on the basis of Heft-Parker visual analogue scale recordings up on the access cavity preparation or initial instrumentation. Data were analyzed by Kruskal-Wallis, and ANOVA tests.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Introduction: to evaluate the efficacy of inferior alveolar nerve block (IANB), Gow-Gates nerve block (GGNB), and their combination in patients with irreversible pulpitis. Methods: One hundred fifty subjects with irreversible pulpitis of a mandibular molar were selected. subjects randomly received two IANB injections or two GGNB injections or their combination of 1.8 mL 2% lidocaine with 1:100,000 epinephrine. Success was specified as no or mild pain on the basis of Heft-Parker visual analogue scale recordings up on the access cavity preparation or initial instrumentation. Data were analyzed by Kruskal-Wallis, and ANOVA tests.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 3

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • vital mandibular molar tooth
  • diagnosis of symptomatic irreversible pulpitis

Exclusion Criteria:

  • younger than 18 years old
  • history of significant medical conditions
  • allergies to local anesthetics or sulfites
  • pregnancy
  • taking any medications that might influence anesthetic assessment
  • active sites of pathosis in area of injection
  • inability to give informed consent

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: GGNB injection technique
In GGNB group, every patient received two1.8-mL cartridges of 2% lidocaine with 1:80,000 epinephrine using the GGNB technique
Procedure: GGNB injections
The patients received two GGNB injections of 1.8 mL 2% lidocaine with 1:100,000 epinephrine
Active Comparator: IANB injection technique
In IANB group, every patient received two 1.8-mL cartridges of 2% lidocaine with 1:80,000 epinephrine using the IANB technique
Procedure: IANB injections
The patients received two IANB injections of 1.8 mL 2% lidocaine with 1:100,000 epinephrine
Active Comparator: GGNB + IANB injection technique
In IANB + GGNB group, every patient received one 1.8-mL cartridges of 2% lidocaine with 1:80,000 epinephrine using the IANB technique and one 1.8-mL cartridges of 2% lidocaine with 1:80,000 epinephrine using the GGNB technique
Procedure: GGNB + IANB injections
The patients received one GGNB injection plus one IANB injection of 1.8 mL 2% lidocaine with 1:100,000 epinephrine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the success rate of GGNB local anesthesia technique based on Heft-Parker visual analog scale
Time Frame: at time of access cavity preparation
at time of access cavity preparation
the success rate of IANB local anesthesia technique based on Heft-Parker visual analog scale
Time Frame: at time of access cavity preparation
at time of access cavity preparation
the success rate of GGNB + IANB local anesthesia techniques based on Heft-Parker visual analog scale
Time Frame: at time of access cavity preparation
at time of access cavity preparation

Secondary Outcome Measures

Outcome Measure
Time Frame
initial pain based on Heft-Parker visual analog scale
Time Frame: before treatment
before treatment

Collaborators and Investigators

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

Sponsor

Isfahan University of Medical Sciences

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 (Actual)

December 1, 2015

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

April 3, 2017

First Submitted That Met QC Criteria

April 12, 2017

First Posted (Actual)

April 18, 2017

Study Record Updates

Last Update Posted (Actual)

May 9, 2017

Last Update Submitted That Met QC Criteria

May 4, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 395437

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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