NCT03117491

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2015

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

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

December 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 18, 2017

Completed
Last Updated

May 9, 2017

Status Verified

April 1, 2017

Enrollment Period

11 months

First QC Date

April 3, 2017

Last Update Submit

May 4, 2017

Conditions

Symptomatic Irreversible Pulpitis

Keywords

Gow-Gates nerve blockInferior alveolar nerve blocklocal anesthesiamolarpulpitis

Outcome Measures

Primary Outcomes (3)

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

    at time of access cavity preparation

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

    at time of access cavity preparation

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

    at time of access cavity preparation

Secondary Outcomes (1)

  • initial pain based on Heft-Parker visual analog scale

    before treatment

Study Arms (3)

GGNB injection technique

ACTIVE COMPARATOR

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

IANB injection technique

ACTIVE COMPARATOR

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

GGNB + IANB injection technique

ACTIVE COMPARATOR

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

Interventions

GGNB injectionsPROCEDURE

The patients received two GGNB injections of 1.8 mL 2% lidocaine with 1:100,000 epinephrine

GGNB injection technique
IANB injectionsPROCEDURE

The patients received two IANB injections of 1.8 mL 2% lidocaine with 1:100,000 epinephrine

IANB injection technique
GGNB + IANB injectionsPROCEDURE

The patients received one GGNB injection plus one IANB injection of 1.8 mL 2% lidocaine with 1:100,000 epinephrine

GGNB + IANB injection technique

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • vital mandibular molar tooth
  • diagnosis of symptomatic irreversible pulpitis

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Isfahan University of Medical Sciences

Isfahan, Iran

Location

MeSH Terms

Conditions

Pulpitis

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Endodontics

Study Record Dates

First Submitted

April 3, 2017

First Posted

April 18, 2017

Study Start

December 1, 2015

Primary Completion

November 1, 2016

Study Completion

December 1, 2016

Last Updated

May 9, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)