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

Primary Purpose

Symptomatic Irreversible Pulpitis

Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
GGNB injections
IANB injections
GGNB + IANB injections
Sponsored by
Isfahan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Symptomatic Irreversible Pulpitis focused on measuring Gow-Gates nerve block, Inferior alveolar nerve block, local anesthesia, molar, pulpitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Isfahan University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

GGNB injection technique

IANB injection technique

GGNB + IANB injection technique

Arm Description

In GGNB group, every patient received two1.8-mL cartridges of 2% lidocaine with 1:80,000 epinephrine using the GGNB technique

In IANB group, every patient received two 1.8-mL cartridges of 2% lidocaine with 1:80,000 epinephrine using the IANB 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

Outcomes

Primary Outcome Measures

the success rate of GGNB local anesthesia technique based on Heft-Parker visual analog scale
the success rate of IANB local anesthesia technique based on Heft-Parker visual analog scale
the success rate of GGNB + IANB local anesthesia techniques based on Heft-Parker visual analog scale

Secondary Outcome Measures

initial pain based on Heft-Parker visual analog scale

Full Information

First Posted
April 3, 2017
Last Updated
May 4, 2017
Sponsor
Isfahan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03117491
Brief Title
Effect of Inferior Alveolar and Gow-Gates Nerve Block Techniques for Symptomatic Mandibular Molars
Official Title
Effect of Inferior Alveolar and Gow-Gates Nerve Block Techniques for Symptomatic Mandibular Molars
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
December 1, 2015 (Actual)
Primary Completion Date
November 1, 2016 (Actual)
Study Completion Date
December 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Irreversible Pulpitis
Keywords
Gow-Gates nerve block, Inferior alveolar nerve block, local anesthesia, molar, pulpitis

7. Study Design

Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GGNB injection technique
Arm Type
Active Comparator
Arm Description
In GGNB group, every patient received two1.8-mL cartridges of 2% lidocaine with 1:80,000 epinephrine using the GGNB technique
Arm Title
IANB injection technique
Arm Type
Active Comparator
Arm Description
In IANB group, every patient received two 1.8-mL cartridges of 2% lidocaine with 1:80,000 epinephrine using the IANB technique
Arm Title
GGNB + IANB injection technique
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
GGNB injections
Intervention Description
The patients received two GGNB injections of 1.8 mL 2% lidocaine with 1:100,000 epinephrine
Intervention Type
Procedure
Intervention Name(s)
IANB injections
Intervention Description
The patients received two IANB injections of 1.8 mL 2% lidocaine with 1:100,000 epinephrine
Intervention Type
Procedure
Intervention Name(s)
GGNB + IANB injections
Intervention Description
The patients received one GGNB injection plus one IANB injection of 1.8 mL 2% lidocaine with 1:100,000 epinephrine
Primary Outcome Measure Information:
Title
the success rate of GGNB local anesthesia technique based on Heft-Parker visual analog scale
Time Frame
at time of access cavity preparation
Title
the success rate of IANB local anesthesia technique based on Heft-Parker visual analog scale
Time Frame
at time of access cavity preparation
Title
the success rate of GGNB + IANB local anesthesia techniques based on Heft-Parker visual analog scale
Time Frame
at time of access cavity preparation
Secondary Outcome Measure Information:
Title
initial pain based on Heft-Parker visual analog scale
Time Frame
before treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Isfahan University of Medical Sciences
City
Isfahan
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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